Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. (REAL 1)

• ClinicalTrials.gov Identifier: NCT02229851
• Recruitment Status: Completed
• First Posted: September 3, 2014
• Results First Posted: July 7, 2020
• Last Update Posted: November 23, 2020
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Interventions: Drug: somapacitan; Drug: somatropin; Drug: placebo
• Enrollment: 301

Participant Flow

Recruitment Details	The trial was conducted at 92 sites in 16 countries: Australia - 8, Germany - 4, India - 5, Japan - 14, Latvia - 1, Lithuania - 2, Malaysia - 3, Poland - 5, Romania - 5, Russian Fed. - 6, South Africa - 3, Sweden - 1, Turkey - 4, Ukraine - 1, United Kingdom - 4, United States - 26.
Pre-assignment Details	The trial had a main phase and an extension phase. Participants were treated for 34 weeks in the main phase (followed by 1 week washout) and for 52 weeks in the extension phase (followed by 1 week washout).300 participants received treatment;1 participant was randomised but didn't receive any treatment and was therefore not included in any analyses

Arm/Group Title	Placebo	Norditropin	Somapacitan	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main phase were randomised 1:1 to continue with norditropin or switch to somapacitan. Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main phase were randomised 1:1 to continue with Norditropin or switch to somapacitan. Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Period Title: Main Phase (Double-blind Phase)
Started	61	119	120	0 [1]	0 [1]	0 [1]	0 [1]
Full Analysis Set	61	119	120	0	0	0	0
Safety Analysis Set	61	119	120	0	0	0	0
Completed	55	103	114	0	0	0	0
Not Completed	6	16	6	0	0	0	0
Reason Not Completed
Unclassified	1	2	0	0	0	0	0
Lost to Follow-up	0	1	0	0	0	0	0
Withdrawal by Subject	4	12	4	0	0	0	0
Protocol Violation	0	0	2	0	0	0	0
Death	1	1	0	0	0	0	0
[1] This arm is not applicable for the Main phase.
Period Title: Extension Phase (Open-label Phase)
Started	0 [1]	0 [1]	0 [1]	55	114	52	51
Completed	0	0	0	53	109	47	48
Not Completed	0	0	0	2	5	5	3
Reason Not Completed
Lost to Follow-up	0	0	0	0	1	1	1
Withdrawal by Subject	0	0	0	1	4	3	1
Death	0	0	0	1	0	1	1
[1] This arm is not applicable for the Extension phase.

Baseline Characteristics

Arm/Group Title		Placebo	Norditropin	Somapacitan	Total
Arm/Group Description		Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants were re-randomised to receive somapacitan while other continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension part of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Total of all reporting groups
Overall Number of Baseline Participants		61	119	120	300
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	61 participants	119 participants	120 participants	300 participants
		45.0 (15.7)	45.7 (15.3)	44.6 (14.3)	45.1 (15.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	61 participants	119 participants	120 participants	300 participants
	Female	32 52.5%	61 51.3%	62 51.7%	155 51.7%
	Male	29 47.5%	58 48.7%	58 48.3%	145 48.3%
Race/Ethnicity, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	61 participants	119 participants	120 participants	300 participants
	Asian	16 26.2%	36 30.3%	34 28.3%	86 28.7%
	Black or African American	2 3.3%	3 2.5%	2 1.7%	7 2.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	1 0.8%	1 0.3%
	White	42 68.9%	76 63.9%	82 68.3%	200 66.7%
	Other: Hispanic	1 1.6%	0 0.0%	1 0.8%	2 0.7%
	Other: Hispanic or Latino	0 0.0%	1 0.8%	0 0.0%	1 0.3%
	Other: Caucasian	0 0.0%	1 0.8%	0 0.0%	1 0.3%
	Not applicable	0 0.0%	2 1.7%	0 0.0%	2 0.7%
		[1] Measure Description: Race
Race/Ethnicity, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	61 participants	119 participants	120 participants	300 participants
	Hispanic or Latino	4 6.6%	8 6.7%	6 5.0%	18 6.0%
	Not Hispanic or Latino	57 93.4%	109 91.6%	114 95.0%	280 93.3%
	Not applicable	0 0.0%	2 1.7%	0 0.0%	2 0.7%
		[1] Measure Description: Ethnicity

Outcome Measures

1. Primary Outcome

Title	Change in Truncal Fat Percentage (Week 34)
Description	Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	111	116
Mean (Standard Deviation); Unit of Measure: Percentage of truncal fat
	0.49 (3.31)	-2.39 (4.48)	-1.17 (2.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Somapacitan
	Comments	Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=0.0090
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-1.53
	Confidence Interval	(2-Sided) 95%; -2.68 to -0.38
	Estimation Comments	Somapacitan-Placebo

2. Secondary Outcome

Title	Change in Truncal Fat Percentage (Week 87)
Description	Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	52	109	48	47
Mean (Standard Deviation); Unit of Measure: Percentage of truncal fat
	-2.16 (3.94)	-1.63 (3.65)	-2.63 (4.65)	-0.96 (4.51)

3. Secondary Outcome

Title	Change in Truncal Fat Mass (Week 34)
Description	Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	111	116
Mean (Standard Deviation); Unit of Measure: grams
	417.86 (1536.36)	-619.67 (1887.50)	-180.98 (1762.31)

4. Secondary Outcome

Title	Change in Truncal Fat Mass (Week 87)
Description	Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	52	109	48	47
Mean (Standard Deviation); Unit of Measure: grams
	-311.85 (1771.78)	-196.18 (2249.21)	-685.56 (2258.93)	364.08 (2548.85)

5. Secondary Outcome

Title	Change in Truncal Lean Body Mass (Week 34)
Description	Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	111	116
Mean (Standard Deviation); Unit of Measure: grams
	402.69 (1247.67)	832.77 (1409.74)	800.27 (1377.75)

6. Secondary Outcome

Title	Change in Truncal Lean Body Mass (Week 87)
Description	Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	52	109	48	47
Mean (Standard Deviation); Unit of Measure: grams
	1197.30 (1500.56)	1152.79 (1480.06)	975.79 (1258.62)	1015.12 (1554.88)

7. Secondary Outcome

Title	Change in Total Fat Mass (Week 34)
Description	Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	111	116
Mean (Standard Deviation); Unit of Measure: grams
	305.47 (2689.06)	-855.71 (3167.06)	-85.47 (3022.71)

8. Secondary Outcome

Title	Change in Total Fat Mass (Week 87)
Description	Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	52	109	48	47
Mean (Standard Deviation); Unit of Measure: grams
	-540.04 (3250.16)	-118.07 (3795.36)	-923.01 (4099.45)	874.56 (4789.34)

9. Secondary Outcome

Title	Change in Visceral Adipose Tissue (Week 34)
Description	Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	53	104	105
Mean (Standard Deviation); Unit of Measure: centimeter square
	4.41 (13.81)	-9.68 (21.37)	-11.61 (23.93)

10. Secondary Outcome

Title	Change in Visceral Adipose Tissue (Week 87)
Description	Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	48	97	40	43
Mean (Standard Deviation); Unit of Measure: centimeter square
	-9.34 (25.67)	-6.71 (33.07)	-5.17 (20.11)	-5.97 (28.86)

11. Secondary Outcome

Title	Change in Android Fat Mass (Week 34)
Description	Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	55	110	114
Mean (Standard Deviation); Unit of Measure: gram
	56.32 (293.93)	-158.98 (325.35)	-81.52 (361.62)

12. Secondary Outcome

Title	Change in Android Fat Mass (Week 87)
Description	Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	51	107	47	47
Mean (Standard Deviation); Unit of Measure: gram
	-107.16 (367.14)	-39.76 (481.66)	-100.76 (386.24)	11.52 (489.85)

13. Secondary Outcome

Title	Change in Gynoid Fat Mass (Week 34)
Description	Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	55	110	114
Mean (Standard Deviation); Unit of Measure: gram
	8.35 (567.04)	-128.59 (471.00)	22.66 (510.45)

14. Secondary Outcome

Title	Change in Gynoid Fat Mass (Week 87)
Description	Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	51	107	47	47
Mean (Standard Deviation); Unit of Measure: gram
	-92.00 (759.37)	10.23 (557.20)	-100.97 (620.16)	140.02 (790.74)

15. Secondary Outcome

Title	Change in Appendicular Skeletal Muscle Mass (Week 34)
Description	Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	111	116
Mean (Standard Deviation); Unit of Measure: gram
	-76.22 (1006.58)	482.76 (1246.89)	565.21 (1011.18)

16. Secondary Outcome

Title	Change in Appendicular Skeletal Muscle Mass (Week 87)
Description	Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	52	109	48	47
Mean (Standard Deviation); Unit of Measure: gram
	447.96 (1688.08)	538.45 (1224.13)	464.75 (1513.96)	632.18 (1928.68)

17. Secondary Outcome

Title	Change in Lean Body Mass (Week 34)
Description	Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	111	116
Mean (Standard Deviation); Unit of Measure: gram
	334.43 (2048.01)	1359.33 (2359.11)	1395.88 (2139.32)

18. Secondary Outcome

Title	Change in Lean Body Mass (Week 87)
Description	Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	52	109	48	47
Mean (Standard Deviation); Unit of Measure: gram
	1717.15 (2965.23)	1719.87 (2515.90)	1464.51 (2439.75)	1681.82 (3413.61)

19. Secondary Outcome

Title	Change in Bone Mineral Content (Week 87)
Description	Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	110	48	47
Mean (Standard Deviation); Unit of Measure: gram
	-25.61 (93.35)	5.02 (113.81)	-10.18 (99.18)	32.33 (87.86)

20. Secondary Outcome

Title	Change in Bone Mineral Density (Week 87)
Description	Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	110	48	47
Mean (Standard Deviation); Unit of Measure: grams per square centimeter
	-0.01 (0.04)	-0.00 (0.04)	-0.00 (0.04)	0.01 (0.04)

21. Secondary Outcome

Title	Change in IGF-I SDS (Week 34)
Description	Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	113	116
Mean (Standard Deviation); Unit of Measure: Standard deviation score
	0.05 (0.59)	2.28 (1.32)	2.37 (1.33)

22. Secondary Outcome

Title	Change in IGF-I SDS (Week 87)
Description	Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	110	47	47
Mean (Standard Deviation); Unit of Measure: Standard deviation score
	2.36 (1.55)	2.29 (1.39)	2.07 (1.12)	2.35 (1.54)

23. Secondary Outcome

Title	Change in IGFBP 3 SDS (Week 34)
Description	Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	113	116
Mean (Standard Deviation); Unit of Measure: Standard deviation score
	0.12 (0.61)	1.44 (1.17)	1.56 (1.24)

24. Secondary Outcome

Title	Change in IGFBP 3 SDS (Week 87)
Description	Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	110	47	47
Mean (Standard Deviation); Unit of Measure: Standard deviation score
	1.33 (1.20)	1.41 (1.20)	1.30 (1.08)	1.47 (1.51)

25. Secondary Outcome

Title	Change in TRIM-AGHD (Total and Domain Scores) (Week 34)
Description	Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
Time Frame	Week 0, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Arm/Group Title		Placebo	Norditropin	Somapacitan
Arm/Group Description:		Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed		61	119	120
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Energy	Number Analyzed	56 participants	112 participants	116 participants
		-3.96 (25.40)	-13.42 (23.73)	-7.81 (24.07)
Psychological	Number Analyzed	56 participants	112 participants	116 participants
		-3.38 (12.15)	-8.93 (14.21)	-4.63 (12.01)
Cognitive	Number Analyzed	56 participants	112 participants	115 participants
		-2.25 (18.17)	-7.06 (18.47)	-3.92 (17.29)
Physical	Number Analyzed	56 participants	112 participants	115 participants
		-5.88 (14.72)	-11.33 (19.23)	-7.39 (19.25)
Total	Number Analyzed	56 participants	112 participants	115 participants
		-3.65 (12.05)	-9.99 (13.64)	-5.71 (12.69)

26. Secondary Outcome

Title	Change in TRIM-AGHD (Total and Domain Scores) (Week 87)
Description	Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
Time Frame	week 0, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Arm/Group Title		Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:		Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed		61	120	52	51
Mean (Standard Deviation); Unit of Measure: Scores on scale
Energy	Number Analyzed	54 participants	111 participants	49 participants	47 participants
		-11.73 (30.87)	-8.11 (25.46)	-23.30 (28.03)	-9.13 (26.98)
Psychological	Number Analyzed	54 participants	111 participants	49 participants	47 participants
		-6.97 (16.05)	-6.64 (14.56)	-15.64 (15.36)	-7.35 (10.50)
Cognitive	Number Analyzed	54 participants	111 participants	49 participants	48 participants
		-4.88 (21.19)	-5.55 (18.59)	-14.18 (20.29)	-7.71 (14.14)
Physical	Number Analyzed	54 participants	111 participants	49 participants	48 participants
		-11.19 (20.13)	-9.57 (21.94)	-17.22 (27.02)	-13.54 (18.02)
Total	Number Analyzed	54 participants	111 participants	49 participants	47 participants
		-8.28 (15.88)	-7.25 (14.42)	-17.38 (16.77)	-8.67 (11.73)

27. Secondary Outcome

Title	Change in SF-36v2 (Summary and Domain Scores) (Week 34)
Description	SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Time Frame	Week 0, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Arm/Group Title		Placebo	Norditropin	Somapacitan
Arm/Group Description:		Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed		61	119	120
Mean (Standard Deviation); Unit of Measure: Scores on scale
Physical functioning	Number Analyzed	55 participants	111 participants	117 participants
		2.19 (6.44)	2.46 (7.08)	3.18 (7.67)
Role limitations due to physical health	Number Analyzed	56 participants	111 participants	117 participants
		2.49 (7.68)	3.95 (8.48)	3.14 (9.06)
Role limitations due to emotional health	Number Analyzed	56 participants	111 participants	117 participants
		2.29 (9.52)	3.50 (10.87)	3.06 (11.60)
Vitality	Number Analyzed	56 participants	111 participants	118 participants
		3.21 (7.67)	5.26 (9.89)	2.38 (8.56)
Role limitations due to mental health	Number Analyzed	56 participants	111 participants	118 participants
		0.85 (9.59)	3.72 (10.17)	2.78 (9.56)
Social functioning	Number Analyzed	56 participants	111 participants	118 participants
		0.10 (10.43)	3.19 (9.80)	2.87 (9.69)
Bodily pain	Number Analyzed	56 participants	111 participants	117 participants
		0.63 (8.79)	2.19 (9.50)	1.79 (9.52)
General health	Number Analyzed	56 participants	111 participants	118 participants
		1.50 (7.25)	4.47 (7.64)	1.85 (7.58)
Overall physical	Number Analyzed	55 participants	111 participants	116 participants
		2.01 (6.22)	2.87 (6.33)	2.40 (6.53)
Overall mental	Number Analyzed	55 participants	111 participants	116 participants
		1.28 (8.72)	4.09 (10.19)	2.70 (9.29)

28. Secondary Outcome

Title	Change in SF-36v2 (Summary and Domain Scores) (Week 87)
Description	SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Time Frame	week 0, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Arm/Group Title		Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:		Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed		61	120	52	51
Mean (Standard Deviation); Unit of Measure: Score on scale
Physical functioning	Number Analyzed	53 participants	111 participants	49 participants	48 participants
		2.87 (8.13)	3.83 (7.66)	3.43 (6.96)	1.84 (8.07)
Role limitations due to physical health	Number Analyzed	54 participants	110 participants	49 participants	48 participants
		3.31 (9.81)	4.16 (10.10)	4.65 (10.06)	2.45 (10.50)
Role limitations due to emotional health	Number Analyzed	54 participants	110 participants	49 participants	48 participants
		3.46 (11.59)	3.46 (12.25)	7.30 (13.46)	1.13 (11.20)
Vitality	Number Analyzed	54 participants	111 participants	49 participants	48 participants
		6.71 (11.01)	4.18 (9.30)	8.16 (12.77)	4.16 (8.88)
Role limitations due to mental health	Number Analyzed	54 participants	111 participants	49 participants	48 participants
		2.80 (10.55)	3.66 (8.12)	6.12 (13.02)	1.70 (10.31)
Social functioning	Number Analyzed	54 participants	111 participants	49 participants	48 participants
		3.84 (10.36)	3.44 (10.29)	4.56 (10.34)	0.57 (11.26)
Bodily pain	Number Analyzed	54 participants	110 participants	49 participants	48 participants
		1.41 (8.57)	1.47 (10.29)	3.51 (9.57)	0.30 (11.25)
General health	Number Analyzed	54 participants	111 participants	49 participants	48 participants
		3.46 (7.33)	3.32 (7.70)	5.66 (9.67)	2.20 (8.66)
Overall physical score	Number Analyzed	53 participants	109 participants	49 participants	48 participants
		2.66 (6.91)	2.98 (7.24)	3.06 (7.07)	1.81 (7.72)
Overall mental score	Number Analyzed	53 participants	109 participants	49 participants	48 participants
		4.51 (10.39)	3.56 (9.06)	7.50 (13.59)	1.66 (10.18)

29. Secondary Outcome

Title	TSQM-9 Scores (Domain Scores) (Week 34)
Description	Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
Time Frame	Week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.

Arm/Group Title		Placebo	Norditropin	Somapacitan
Arm/Group Description:		Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed		61	119	120
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Effectiveness	Number Analyzed	55 participants	110 participants	118 participants
		49.6 (22.2)	67.1 (21.8)	56.1 (22.5)
Convenience	Number Analyzed	55 participants	111 participants	118 participants
		74.3 (16.9)	73.9 (18.7)	77.7 (15.3)
Global satisfaction	Number Analyzed	55 participants	110 participants	118 participants
		54.0 (24.8)	69.0 (24.0)	63.1 (24.2)

30. Secondary Outcome

Title	TSQM-9 Scores (Domain Scores) (Week 87)
Description	Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
Time Frame	Week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.

Arm/Group Title		Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:		Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed		61	120	52	51
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Effectiveness	Number Analyzed	54 participants	111 participants	49 participants	49 participants
		59.7 (23.1)	65.7 (22.4)	69.6 (24.0)	70.9 (20.9)
Convenience	Number Analyzed	61 participants	120 participants	52 participants	49 participants
		75.1 (19.1)	80.0 (16.5)	72.6 (20.0)	79.4 (17.1)
Global satisfaction	Number Analyzed	61 participants	120 participants	52 participants	49 participants
		63.2 (26.2)	68.1 (24.6)	71.7 (25.3)	75.1 (23.6)

31. Secondary Outcome

Title	Change in Total Cholesterol (Week 34)
Description	Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	119
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.03 (0.96)	-0.10 (0.91)	-0.09 (0.78)

32. Secondary Outcome

Title	Change in Total Cholesterol (Week 87)
Description	Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	-0.21 (0.89)	0.03 (0.96)	-0.05 (0.94)	-0.33 (1.08)

33. Secondary Outcome

Title	Change in HDL-cholesterol (Week 34)
Description	Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	119
Mean (Standard Deviation); Unit of Measure: mmol/L
	-0.00 (0.37)	0.02 (0.28)	0.05 (0.30)

34. Secondary Outcome

Title	Change in HDL-cholesterol (Week 87)
Description	Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.06 (0.30)	0.05 (0.32)	0.09 (0.27)	0.06 (0.34)

35. Secondary Outcome

Title	Change in LDL-cholesterol (Week 34)
Description	Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	119
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.02 (0.75)	-0.18 (0.72)	-0.13 (0.64)

36. Secondary Outcome

Title	Change in LDL-cholesterol (Week 87)
Description	Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	-0.30 (0.72)	-0.06 (0.81)	-0.15 (0.85)	-0.36 (0.90)

37. Secondary Outcome

Title	Change in Triglycerides (Week 34)
Description	Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	119
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.01 (0.65)	0.13 (0.62)	-0.02 (0.73)

38. Secondary Outcome

Title	Change in Triglycerides (Week 87)
Description	Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.07 (0.48)	0.03 (0.76)	0.03 (0.56)	-0.08 (0.73)

39. Secondary Outcome

Title	Change in Hs-CRP (Week 34)
Description	Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	116
Mean (Standard Deviation); Unit of Measure: mg/L
	0.405 (13.144)	-1.604 (13.254)	-0.569 (5.616)

40. Secondary Outcome

Title	Change in Hs-CRP (Week 87)
Description	Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	111	49	49
Mean (Standard Deviation); Unit of Measure: mg/L
	-0.325 (16.247)	-1.445 (3.791)	-0.857 (17.491)	-1.257 (12.497)

41. Secondary Outcome

Title	Change in IL-6 (Week 34)
Description	Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	113	118
Mean (Standard Deviation); Unit of Measure: pg/mL
	3.48 (24.84)	0.07 (4.01)	0.18 (5.78)

42. Secondary Outcome

Title	Change in IL-6 (Week 87)
Description	Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	111	48	47
Mean (Standard Deviation); Unit of Measure: pg/mL
	0.11 (3.30)	0.52 (6.19)	0.49 (5.12)	1.19 (2.92)

43. Secondary Outcome

Title	Change in Body Weight (Week 34)
Description	Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	119
Mean (Standard Deviation); Unit of Measure: Kg
	0.6 (2.9)	0.2 (4.0)	1.3 (4.2)

44. Secondary Outcome

Title	Change in Body Weight (Week 87)
Description	Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: Kg
	1.2 (4.4)	1.4 (4.8)	0.4 (5.2)	2.1 (7.0)

45. Secondary Outcome

Title	Change in Waist Circumference (Week 34)
Description	Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	55	113	117
Mean (Standard Deviation); Unit of Measure: cm
	0.82 (4.50)	-0.66 (4.83)	-0.00 (4.52)

46. Secondary Outcome

Title	Change in Waist Circumference (Week 87)
Description	Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	111	49	49
Mean (Standard Deviation); Unit of Measure: cm
	1.35 (5.62)	0.53 (5.17)	-2.26 (7.93)	0.74 (7.17)

47. Secondary Outcome

Title	Number of Adverse Events (Weeks 0-35)
Description	Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.
Time Frame	Weeks 0-35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	61	119	120
Measure Type: Number; Unit of Measure: Events
	184	426	385

48. Secondary Outcome

Title	Number of Adverse Events (Weeks 0-88)
Description	Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.
Time Frame	Weeks 0-88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan	Norditropin/-
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Overall Number of Participants Analyzed	61	120	52	51	16
Measure Type: Number; Unit of Measure: Events
	395	699	384	385	49

49. Secondary Outcome

Title	Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)
Description	Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
Time Frame	Weeks 0 to 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	61	109	120
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	1 0.9%	0 0.0%

50. Secondary Outcome

Title	Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)
Description	Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
Time Frame	Weeks 0 to 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan	Norditropin/-
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Overall Number of Participants Analyzed	61	120	52	51	16
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.3%

51. Secondary Outcome

Title	Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)
Description	Incidence of technical complaints were recorded from baseline (week 0) until week 35.
Time Frame	Weeks 0 to 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	61	119	120
Measure Type: Number; Unit of Measure: Technical complaints
	1	14	0

52. Secondary Outcome

Title	Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)
Description	Incidence of technical complaints were recorded from baseline (week 0) until week 88.
Time Frame	Weeks 0 to 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	61	120	52	51
Measure Type: Number; Unit of Measure: Technical complaints
	1	6	18	7

53. Secondary Outcome

Title	Change in Physical Examination During Exposure to Trial Product (Week 35)
Description	Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation
Time Frame	Week 0 and week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Arm/Group Title		Placebo	Norditropin	Somapacitan
Arm/Group Description:		Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed		61	119	120
Measure Type: Count of Participants; Unit of Measure: Participants
Head, neck, eyes, nose (Week 0)	Number Analyzed	61 participants	119 participants	120 participants
	Normal	55 90.2%	111 93.3%	108 90.0%
	Abnormal, not clinically significant (NCS)	6 9.8%	6 5.0%	7 5.8%
	Abnormal, clinically significant (CS)	0 0.0%	2 1.7%	5 4.2%
	Missing	0 0.0%	0 0.0%	0 0.0%
Head, neck, eyes, nose (Week 35)	Number Analyzed	56 participants	105 participants	118 participants
	Normal	51 91.1%	98 93.3%	107 90.7%
	Abnormal, not clinically significant (NCS)	5 8.9%	4 3.8%	9 7.6%
	Abnormal, clinically significant (CS)	0 0.0%	3 2.9%	2 1.7%
	Missing	0 0.0%	0 0.0%	0 0.0%
Respiratory sys. (Week 0)	Number Analyzed	61 participants	119 participants	120 participants
	Normal	61 100.0%	118 99.2%	119 99.2%
	Abnormal, not clinically significant (NCS)	0 0.0%	1 0.8%	1 0.8%
	Abnormal, clinically significant (CS)	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Respiratory sys. (Week 35)	Number Analyzed	56 participants	105 participants	118 participants
	Normal	56 100.0%	103 98.1%	117 99.2%
	Abnormal, not clinically significant (NCS)	0 0.0%	2 1.9%	1 0.8%
	Abnormal, clinically significant (CS)	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Cardiovascular sys. (Week 0)	Number Analyzed	61 participants	119 participants	120 participants
	Normal	56 91.8%	112 94.1%	116 96.7%
	Abnormal, not clinically significant (NCS)	4 6.6%	7 5.9%	4 3.3%
	Abnormal, clinically significant (CS)	1 1.6%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Cardiovascular sys. (Week 35)	Number Analyzed	56 participants	105 participants	118 participants
	Normal	54 96.4%	99 94.3%	112 94.9%
	Abnormal, not clinically significant (NCS)	1 1.8%	6 5.7%	6 5.1%
	Abnormal, clinically significant (CS)	1 1.8%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Gastrointestinal sys. (Week 0)	Number Analyzed	61 participants	119 participants	120 participants
	Normal	59 96.7%	113 95.0%	119 99.2%
	Abnormal, not clinically significant (NCS)	2 3.3%	6 5.0%	1 0.8%
	Abnormal, clinically significant (CS)	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Gastrointestinal sys. (Week 35)	Number Analyzed	56 participants	105 participants	118 participants
	Normal	53 94.6%	98 93.3%	116 98.3%
	Abnormal, not clinically significant (NCS)	3 5.4%	7 6.7%	2 1.7%
	Abnormal, clinically significant (CS)	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Musculoskeletal sys. (Week 0)	Number Analyzed	61 participants	119 participants	120 participants
	Normal	59 96.7%	111 93.3%	113 94.2%
	Abnormal, not clinically significant (NCS)	2 3.3%	6 5.0%	5 4.2%
	Abnormal, clinically significant (CS)	0 0.0%	2 1.7%	2 1.7%
	Missing	0 0.0%	0 0.0%	0 0.0%
Musculoskeletal sys. (Week 35)	Number Analyzed	56 participants	105 participants	118 participants
	Normal	54 96.4%	96 91.4%	111 94.1%
	Abnormal, not clinically significant (NCS)	2 3.6%	7 6.7%	5 4.2%
	Abnormal, clinically significant (CS)	0 0.0%	2 1.9%	2 1.7%
	Missing	0 0.0%	0 0.0%	0 0.0%
Central & Peripheral nervous sys (Week 0)	Number Analyzed	61 participants	119 participants	120 participants
	Normal	59 96.7%	113 95.0%	117 97.5%
	Abnormal, not clinically significant (NCS)	2 3.3%	5 4.2%	3 2.5%
	Abnormal, clinically significant (CS)	0 0.0%	1 0.8%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Central & Peripheral nervous sys (Week 35)	Number Analyzed	56 participants	105 participants	118 participants
	Normal	55 98.2%	101 96.2%	114 96.6%
	Abnormal, not clinically significant (NCS)	1 1.8%	4 3.8%	4 3.4%
	Abnormal, clinically significant (CS)	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Skin (Week 0)	Number Analyzed	61 participants	119 participants	120 participants
	Normal	51 83.6%	100 84.0%	109 90.8%
	Abnormal, not clinically significant (NCS)	9 14.8%	17 14.3%	11 9.2%
	Abnormal, clinically significant (CS)	1 1.6%	2 1.7%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Skin (Week 35)	Number Analyzed	56 participants	105 participants	118 participants
	Normal	51 91.1%	88 83.8%	102 86.4%
	Abnormal, not clinically significant (NCS)	5 8.9%	15 14.3%	13 11.0%
	Abnormal, clinically significant (CS)	0 0.0%	2 1.9%	3 2.5%
	Missing	0 0.0%	0 0.0%	0 0.0%
Lymph node palpation (Week 0)	Number Analyzed	61 participants	119 participants	120 participants
	Normal	61 100.0%	119 100.0%	120 100.0%
	Abnormal, not clinically significant (NCS)	0 0.0%	0 0.0%	0 0.0%
	Abnormal, clinically significant (CS)	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%
Lymph node palpation (Week 35)	Number Analyzed	56 participants	105 participants	118 participants
	Normal	56 100.0%	105 100.0%	118 100.0%
	Abnormal, not clinically significant (NCS)	0 0.0%	0 0.0%	0 0.0%
	Abnormal, clinically significant (CS)	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%

54. Secondary Outcome

Title	Change in Physical Examination During Exposure to Trial Product (Week 88)
Description	Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation
Time Frame	Week 0 and week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Arm/Group Title		Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan	Norditropin/-
Arm/Group Description:		Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Overall Number of Participants Analyzed		61	120	52	51	16
Measure Type: Count of Participants; Unit of Measure: Participants
Head, neck, eyes, nose (Week 0)	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	55 90.2%	108 90.0%	49 94.2%	47 92.2%	15 93.8%
	Abnormal, NCS	6 9.8%	7 5.8%	2 3.8%	3 5.9%	1 6.3%
	Abnormal, CS	0 0.0%	5 4.2%	1 1.9%	1 2.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Head, neck, eyes, nose (Week 88)	Number Analyzed	54 participants	110 participants	49 participants	48 participants	0 participants
	Normal	48 88.9%	101 91.8%	46 93.9%	44 91.7%	0
	Abnormal, NCS	6 11.1%	7 6.4%	2 4.1%	1 2.1%	0
	Abnormal, CS	0 0.0%	1 0.9%	1 2.0%	3 6.3%	0
	Missing	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0
Respiratory sys. (Week 0)	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	61 100.0%	119 99.2%	52 100.0%	50 98.0%	16 100.0%
	Abnormal, NCS	0 0.0%	1 0.8%	0 0.0%	1 2.0%	0 0.0%
	Abnormal, CS	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Respiratory sys. (Week 88)	Number Analyzed	54 participants	110 participants	49 participants	48 participants	0 participants
	Normal	54 100.0%	109 99.1%	49 100.0%	47 97.9%	0
	Abnormal, NCS	0 0.0%	0 0.0%	0 0.0%	1 2.1%	0
	Abnormal, CS	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0
	Missing	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0
Cardiovascular sys. (Week 0)	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	56 91.8%	116 96.7%	49 94.2%	47 92.2%	16 100.0%
	Abnormal, NCS	4 6.6%	4 3.3%	3 5.8%	4 7.8%	0 0.0%
	Abnormal, CS	1 1.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Cardiovascular sys. (Week 88)	Number Analyzed	54 participants	110 participants	49 participants	48 participants	0 participants
	Normal	52 96.3%	107 97.3%	45 91.8%	47 97.9%	0
	Abnormal, NCS	1 1.9%	2 1.8%	4 8.2%	1 2.1%	0
	Abnormal, CS	1 1.9%	0 0.0%	0 0.0%	0 0.0%	0
	Missing	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0
Gastrointestinal sys. (Week 0)	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	59 96.7%	119 99.2%	49 94.2%	49 96.1%	15 93.8%
	Abnormal, NCS	2 3.3%	1 0.8%	3 5.8%	2 3.9%	1 6.3%
	Abnormal, CS	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Gastrointestinal sys. (Week 88)	Number Analyzed	54 participants	110 participants	49 participants	48 participants	0 participants
	Normal	52 96.3%	109 99.1%	47 95.9%	48 100.0%	0
	Abnormal, NCS	2 3.7%	0 0.0%	2 4.1%	0 0.0%	0
	Abnormal, CS	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0
	Missing	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0
Musculoskeletal sys. (Week 0)	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	59 96.7%	113 94.2%	48 92.3%	49 96.1%	14 87.5%
	Abnormal, NCS	2 3.3%	5 4.2%	2 3.8%	2 3.9%	2 12.5%
	Abnormal, CS	0 0.0%	2 1.7%	2 3.8%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Musculoskeletal sys. (Week 88)	Number Analyzed	54 participants	110 participants	49 participants	48 participants	0 participants
	Normal	49 90.7%	101 91.8%	45 91.8%	46 95.8%	0
	Abnormal, NCS	4 7.4%	7 6.4%	3 6.1%	2 4.2%	0
	Abnormal, CS	1 1.9%	1 0.9%	1 2.0%	0 0.0%	0
	Missing	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0
Central & Peripheral nervous sys. (week 0)	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	59 96.7%	117 97.5%	51 98.1%	48 94.1%	14 87.5%
	Abnormal, NCS	2 3.3%	3 2.5%	1 1.9%	3 5.9%	1 6.3%
	Abnormal, CS	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.3%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Central & Peripheral nervous sys. (week 88)	Number Analyzed	54 participants	110 participants	49 participants	48 participants	0 participants
	Normal	53 98.1%	106 96.4%	49 100.0%	45 93.8%	0
	Abnormal, NCS	1 1.9%	3 2.7%	0 0.0%	3 6.3%	0
	Abnormal, CS	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0
	Missing	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0
Skin (Week 0)	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	51 83.6%	109 90.8%	48 92.3%	41 80.4%	11 68.8%
	Abnormal, NCS	9 14.8%	11 9.2%	3 5.8%	10 19.6%	4 25.0%
	Abnormal, CS	1 1.6%	0 0.0%	1 1.9%	0 0.0%	1 6.3%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Skin (Week 88)	Number Analyzed	54 participants	110 participants	49 participants	48 participants	0 participants
	Normal	49 90.7%	96 87.3%	42 85.7%	42 87.5%	0
	Abnormal, NCS	3 5.6%	8 7.3%	6 12.2%	5 10.4%	0
	Abnormal, CS	2 3.7%	5 4.5%	1 2.0%	1 2.1%	0
	Missing	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0
Lymph node palpation (week 0)	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	61 100.0%	120 100.0%	52 100.0%	51 100.0%	16 100.0%
	Abnormal, NCS	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Abnormal, CS	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Lymph node palpation (week 88)	Number Analyzed	54 participants	110 participants	49 participants	48 participants	0 participants
	Normal	53 98.1%	108 98.2%	49 100.0%	48 100.0%	0
	Abnormal, NCS	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0
	Abnormal, CS	1 1.9%	0 0.0%	0 0.0%	0 0.0%	0
	Missing	0 0.0%	1 0.9%	0 0.0%	0 0.0%	0

55. Secondary Outcome

Title	Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)
Description	Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.
Time Frame	Week -3 and week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Arm/Group Title		Placebo	Norditropin	Somapacitan
Arm/Group Description:		Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed		61	119	120
Measure Type: Count of Participants; Unit of Measure: Participants
Week -3	Number Analyzed	61 participants	119 participants	120 participants
	Normal	30 49.2%	67 56.3%	77 64.2%
	Abnormal, NCS	29 47.5%	52 43.7%	40 33.3%
	Abnormal, CS	2 3.3%	0 0.0%	3 2.5%
	Missing	0 0.0%	0 0.0%	0 0.0%
Week 35	Number Analyzed	57 participants	111 participants	119 participants
	Normal	29 50.9%	65 58.6%	77 64.7%
	Abnormal, NCS	26 45.6%	42 37.8%	34 28.6%
	Abnormal, CS	1 1.8%	0 0.0%	2 1.7%
	Missing	1 1.8%	4 3.6%	6 5.0%

56. Secondary Outcome

Title	Change in ECG Evaluation During Exposure to Trial Product (Week 88)
Description	Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.
Time Frame	Week -3 and week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Arm/Group Title		Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan	Norditropin/-
Arm/Group Description:		Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Overall Number of Participants Analyzed		61	120	52	51	16
Measure Type: Count of Participants; Unit of Measure: Participants
Week -3	Number Analyzed	61 participants	120 participants	52 participants	51 participants	16 participants
	Normal	30 49.2%	77 64.2%	26 50.0%	34 66.7%	7 43.8%
	Abnormal, NCS	29 47.5%	40 33.3%	26 50.0%	17 33.3%	9 56.3%
	Abnormal, CS	2 3.3%	3 2.5%	0 0.0%	0 0.0%	0 0.0%
	Missing	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Week 88	Number Analyzed	54 participants	109 participants	49 participants	49 participants	1 participants
	Normal	34 63.0%	74 67.9%	29 59.2%	35 71.4%	0 0.0%
	Abnormal, NCS	18 33.3%	34 31.2%	18 36.7%	12 24.5%	0 0.0%
	Abnormal, CS	1 1.9%	1 0.9%	2 4.1%	1 2.0%	0 0.0%
	Missing	1 1.9%	0 0.0%	0 0.0%	1 2.0%	1 100.0%

57. Secondary Outcome

Title	Change in Diastolic Blood Pressure (Week 35)
Description	Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time Frame	Week -3, week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	107	118
Mean (Standard Deviation); Unit of Measure: mm Hg
	-0.41 (7.75)	-2.07 (8.73)	-1.42 (8.98)

58. Secondary Outcome

Title	Change in Diastolic Blood Pressure (Week 88)
Description	Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.
Time Frame	Week -3, week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	110	49	48
Mean (Standard Deviation); Unit of Measure: mm Hg
	-2.48 (7.77)	-0.85 (9.21)	-0.61 (8.71)	-2.10 (9.50)

59. Secondary Outcome

Title	Change in Systolic Blood Pressure (Week 35)
Description	Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time Frame	Week -3, week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	107	118
Mean (Standard Deviation); Unit of Measure: mm Hg
	1.13 (11.35)	-2.81 (13.33)	-1.39 (12.89)

60. Secondary Outcome

Title	Change in Systolic Blood Pressure (Week 88)
Description	Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Time Frame	Week -3, week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	110	49	48
Mean (Standard Deviation); Unit of Measure: mm Hg
	-1.30 (12.18)	0.45 (13.01)	-1.35 (13.07)	-1.83 (11.63)

61. Secondary Outcome

Title	Change in Pulse (Week 35)
Description	Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time Frame	Week -3, week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	119
Mean (Standard Deviation); Unit of Measure: beats/min
	0.54 (9.43)	2.61 (9.74)	1.02 (10.20)

62. Secondary Outcome

Title	Change in Pulse (Week 88)
Description	Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Time Frame	Week -3, week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	110	49	48
Mean (Standard Deviation); Unit of Measure: beats/min
	0.78 (11.70)	-0.55 (10.51)	-0.55 (10.32)	0.08 (8.75)

63. Secondary Outcome

Title	Change in Haemoglobin (Week 34)
Description	Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	112	119
Mean (Standard Deviation); Unit of Measure: g/L
	1.87 (10.25)	-0.51 (8.80)	0.64 (8.78)

64. Secondary Outcome

Title	Change in Haemoglobin (Week 87)
Description	Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	109	48	48
Mean (Standard Deviation); Unit of Measure: g/L
	2.93 (11.36)	2.76 (9.54)	-0.40 (9.22)	0.86 (15.96)

65. Secondary Outcome

Title	Change in Haematocrit (Week 34)
Description	Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	112	119
Mean (Standard Deviation); Unit of Measure: % of red blood cells
	0.5 (3.3)	-0.3 (2.9)	0.1 (3.1)

66. Secondary Outcome

Title	Change in Haematocrit (Week 87)
Description	Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	109	48	48
Mean (Standard Deviation); Unit of Measure: % of red blood cells
	0.17 (3.44)	0.21 (3.29)	-0.59 (2.78)	-0.48 (5.10)

67. Secondary Outcome

Title	Change in Erythrocytes (Week 34)
Description	Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	112	119
Mean (Standard Deviation); Unit of Measure: cells/pL
	0.09 (0.33)	0.06 (0.29)	0.08 (0.32)

68. Secondary Outcome

Title	Change in Erythrocytes (Week 87)
Description	Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	109	48	48
Mean (Standard Deviation); Unit of Measure: cells/pL
	0.09 (0.34)	0.12 (0.35)	0.01 (0.31)	0.05 (0.54)

69. Secondary Outcome

Title	Change in Mean Corpuscular Volume (MCV) (Week 34)
Description	Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	112	119
Mean (Standard Deviation); Unit of Measure: fL
	-0.6 (3.3)	-1.8 (3.6)	-1.5 (3.0)

70. Secondary Outcome

Title	Change in Mean Corpuscular Volume (MCV) (Week 87)
Description	Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	109	48	48
Mean (Standard Deviation); Unit of Measure: fL
	-1.39 (4.27)	-1.80 (3.31)	-1.31 (3.63)	-1.77 (3.66)

71. Secondary Outcome

Title	Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)
Description	Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	112	119
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.1 (0.5)	0.1 (0.6)	0.1 (0.6)

72. Secondary Outcome

Title	Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)
Description	Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	109	48	48
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.36 (0.47)	0.29 (0.61)	0.23 (0.70)	0.35 (0.52)

73. Secondary Outcome

Title	Change in Thrombocytes (Week 34)
Description	Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	111	115
Mean (Standard Deviation); Unit of Measure: 10^9 cells/L
	1.6 (37.4)	10.8 (37.1)	15.3 (35.0)

74. Secondary Outcome

Title	Change in Thrombocytes (Week 87)
Description	Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	108	47	48
Mean (Standard Deviation); Unit of Measure: 10^9 cells/L
	-1.2 (44.7)	11.0 (36.7)	-0.9 (31.3)	6.6 (53.4)

75. Secondary Outcome

Title	Change in Leucocytes (Week 34)
Description	Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	112	119
Mean (Standard Deviation); Unit of Measure: 10^9 cells/L
	0.22 (1.57)	-0.05 (1.50)	-0.32 (1.75)

76. Secondary Outcome

Title	Change in Leucocytes (Week 87)
Description	Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	109	48	48
Mean (Standard Deviation); Unit of Measure: 10^9 cells/L
	0.29 (1.93)	-0.12 (1.94)	-0.14 (1.44)	-0.14 (2.55)

77. Secondary Outcome

Title	Change in Alanine Aminotransferase (ALT) (Week 34)
Description	Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: U/L
	4.5 (24.7)	-1.4 (11.9)	-4.4 (17.9)

78. Secondary Outcome

Title	Change in Alanine Aminotransferase (ALT) (Week 87)
Description	Change in ALT was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: U/L
	-1.1 (13.1)	-4.3 (16.9)	0.6 (12.5)	-3.0 (14.6)

79. Secondary Outcome

Title	Change in Albumin (Week 34)
Description	Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: g/L
	6.09 (3.56)	-0.72 (2.81)	-0.42 (3.06)

80. Secondary Outcome

Title	Change in Albumin (Week 87)
Description	Change in Albumin was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: g/L
	-1.19 (3.15)	-0.86 (3.12)	-1.12 (3.52)	-1.69 (3.01)

81. Secondary Outcome

Title	Change in Alkaline Phosphatase (ALP) (Week 34)
Description	Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	112	118
Mean (Standard Deviation); Unit of Measure: U/L
	1.8 (16.5)	7.9 (24.3)	5.8 (14.9)

82. Secondary Outcome

Title	Change in Alkaline Phosphatase (AP) (Week 87)
Description	Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	48	49
Mean (Standard Deviation); Unit of Measure: U/L
	8.1 (20.2)	5.4 (16.0)	3.3 (22.2)	4.2 (18.0)

83. Secondary Outcome

Title	Change in Aspartate Aminotransferase (AST) (Week 34)
Description	Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: U/L
	1.96 (15.11)	-0.80 (9.38)	-2.00 (13.97)

84. Secondary Outcome

Title	Change in Aspartate Aminotransferase (AST) (Week 87)
Description	Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: U/L
	1.76 (24.346)	-2.17 (13.98)	-0.43 (5.94)	-1.69 (12.75)

85. Secondary Outcome

Title	Change in Bilirubin (Week 34)
Description	Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: umol/L
	-0.08 (4.76)	-0.38 (4.10)	-0.41 (4.09)

86. Secondary Outcome

Title	Change in Bilirubin (Week 87)
Description	Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	111	47	48
Mean (Standard Deviation); Unit of Measure: umol/L
	0.04 (3.77)	0.14 (4.45)	0.45 (3.24)	-0.33 (4.52)

87. Secondary Outcome

Title	Change in Calcium (Week 34)
Description	Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	112	118
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.00 (0.13)	0.04 (0.14)	0.03 (0.11)

88. Secondary Outcome

Title	Change in Calcium (Week 87)
Description	Change in Calcium was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.01 (0.12)	0.03 (0.12)	0.03 (0.11)	0.01 (0.12)

89. Secondary Outcome

Title	Change in Chloride (Week 34)
Description	Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: mmol/L
	-1.1 (2.7)	-0.6 (2.9)	-0.3 (2.9)

90. Secondary Outcome

Title	Change in Chloride (Week 87)
Description	Change in Chloride was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	-1.8 (3.5)	-1.0 (3.0)	-1.1 (3.2)	-0.6 (3.1)

91. Secondary Outcome

Title	Change in Creatinine (Week 34)
Description	Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: umol/L
	0.9 (9.4)	-2.8 (10.9)	-2.9 (10.6)

92. Secondary Outcome

Title	Change in Creatinine (Week 87)
Description	Change in Creatinine was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: umol/L
	-5.6 (11.9)	-2.5 (11.7)	-2.0 (9.8)	1.8 (41.2)

93. Secondary Outcome

Title	Change in Creatine Kinase (Week 34)
Description	Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: U/L
	5.0 (136.6)	10.9 (101.0)	-23.5 (355.0)

94. Secondary Outcome

Title	Change in Creatine Kinase (Week 87)
Description	Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: U/L
	228.7 (1603.3)	-9.4 (411.3)	1.3 (89.3)	30.5 (125.7)

95. Secondary Outcome

Title	Change in Gamma-glutamyl Transferase (GGT) (Week 34)
Description	Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: U/L
	9.3 (66.2)	-5.8 (17.0)	-4.2 (27.5)

96. Secondary Outcome

Title	Change in Gamma-glutamyl Transferase (GGT) (Week 87)
Description	Change in GGT was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: U/L
	19.4 (16.4)	29.3 (39.3)	25.9 (23.8)	20.7 (13.9)

97. Secondary Outcome

Title	Change in Phosphate (Inorganic) (Week 34)
Description	Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: mmol/L
	-0.038 (0.183)	0.155 (0.182)	0.181 (0.202)

98. Secondary Outcome

Title	Change in Phosphate (Inorganic)(Week 87)
Description	Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.100 (0.190)	0.125 (0.193)	0.076 (0.190)	0.115 (0.219)

99. Secondary Outcome

Title	Change in Potassium (Week 34)
Description	Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	52	113	118
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.02 (0.44)	-0.06 (0.39)	0.04 (9.42)

100. Secondary Outcome

Title	Change in Potassium (Week 87)
Description	Change in Potassium was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	-0.06 (0.45)	0.00 (0.44)	-0.00 (0.40)	-0.03 (0.43)

101. Secondary Outcome

Title	Change in Sodium (Week 34)
Description	Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	55	108	115
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.1 (2.4)	0.1 (2.9)	0.5 (2.7)

102. Secondary Outcome

Title	Change in Sodium (Week 87)
Description	Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	48	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	-0.7 (3.35)	0.0 (2.92)	-0.3 (2.74)	0.5 (2.76)

103. Secondary Outcome

Title	Change in Total Protein (Week 34)
Description	Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: g/L
	-0.26 (5.48)	-0.97 (4.36)	-0.83 (4.93)

104. Secondary Outcome

Title	Change in Total Protein (Week 87)
Description	Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: g/L
	-1.20 (5.17)	-0.74 (4.88)	-1.31 (4.91)	-1.59 (4.37)

105. Secondary Outcome

Title	Change in Urea (Week 34)
Description	Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.17 (1.27)	-0.40 (1.16)	-0.19 (1.24)

106. Secondary Outcome

Title	Change in Urea (Week 87)
Description	Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.11 (1.40)	-0.21 (1.28)	-0.26 (1.35)	-0.03 (2.46)

107. Secondary Outcome

Title	Change in Uric Acid (Week 34)
Description	Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: umol/L
	-8.228 (52.557)	-12.61 (50.534)	-21.11 (57.594)

108. Secondary Outcome

Title	Change in Uric Acid (Week 87)
Description	Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	112	49	49
Mean (Standard Deviation); Unit of Measure: umol/L
	-25.22 (59.042)	-21.95 (58.903)	-18.02 (59.716)	-31.31 (86.787)

109. Secondary Outcome

Title	Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)
Description	Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	113	118
Mean (Standard Deviation); Unit of Measure: mL/min/1.73m^2
	-1.34 (10.68)	2.77 (10.07)	2.57 (11.24)

110. Secondary Outcome

Title	Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)
Description	Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	111	49	49
Mean (Standard Deviation); Unit of Measure: mL/min/1.73m^2
	5.36 (12.67)	2.38 (12.28)	1.44 (10.52)	1.67 (15.77)

111. Secondary Outcome

Title	Change in Fasting Plasma Glucose (Week 34)
Description	Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	55	112	117
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.01 (0.42)	0.12 (0.65)	0.00 (0.56)

112. Secondary Outcome

Title	Change in Fasting Plasma Glucose (Week 87)
Description	Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	108	49	48
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.06 (0.46)	0.13 (0.77)	0.05 (0.68)	0.04 (0.60)

113. Secondary Outcome

Title	Change in Fasting Insulin (Week 34)
Description	Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	56	112	117
Mean (Standard Deviation); Unit of Measure: pmol/L
	14.563 (45.217)	27.580 (76.230)	12.778 (53.703)

114. Secondary Outcome

Title	Change in Fasting Insulin (Week 87)
Description	Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	110	48	48
Mean (Standard Deviation); Unit of Measure: pmol/L
	12.2 (57.31)	-3.7 (62.39)	-6.5 (53.67)	13.4 (54.40)

115. Secondary Outcome

Title	Change in Steady State Beta Cell Function (%B) (Week 34)
Description	Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	53	108	113
Mean (Standard Deviation); Unit of Measure: Percentage of beta cell function
	27.10 (105.45)	36.26 (290.00)	54.90 (173.14)

116. Secondary Outcome

Title	Change in Steady State Beta Cell Function (%B) (Week 87)
Description	Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	105	46	46
Mean (Standard Deviation); Unit of Measure: Percentage of beta cell function
	21.72 (154.22)	-16.54 (148.72)	-7.34 (97.62)	34.54 (161.01)

117. Secondary Outcome

Title	Change in Insulin Resistance (IR %) (Week 34)
Description	Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	53	109	114
Mean (Standard Deviation); Unit of Measure: Percentage of insulin resistance
	0.53 (1.76)	1.26 (3.42)	0.47 (2.32)

118. Secondary Outcome

Title	Change in Insulin Resistance (IR %) (Week 87)
Description	Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	53	106	46	47
Mean (Standard Deviation); Unit of Measure: Percentage of insulin resistance
	0.50 (2.17)	-0.06 (3.14)	-0.02 (1.99)	0.52 (2.26)

119. Secondary Outcome

Title	Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)
Description	Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description:	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Overall Number of Participants Analyzed	57	111	119
Mean (Standard Deviation); Unit of Measure: Percentage of HbA1c
	0.04 (0.37)	0.09 (0.26)	0.09 (0.31)

120. Secondary Outcome

Title	Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)
Description	Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description:	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Overall Number of Participants Analyzed	54	110	49	48
Mean (Standard Deviation); Unit of Measure: Percentage of HbA1c
	0.09 (0.26)	0.11 (0.37)	0.10 (0.28)	0.07 (0.27)

Adverse Events

Time Frame	Weeks 0-88
Adverse Event Reporting Description	All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Arm/Group Title	Placebo - Main Phase		Somapacitan - Main Phase		Norditropin - Main Phase		Somapacitan - Extension Phase		Norditropin- Extension Phase
Arm/Group Description	Participants received placebo for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.		Participants received somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.		Participants received Norditropin® for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.		The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the following listed participants: 1) participants who received placebo in the main phase, and switched to receive somapacitan in the extension phase. 2) Participants who received somapacitan in the main phase were continued to receive somapacitan in the extension phase. 3) Participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive somapacitan in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).		The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive Norditropin® in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).
All-Cause Mortality
	Placebo - Main Phase		Somapacitan - Main Phase		Norditropin - Main Phase		Somapacitan - Extension Phase		Norditropin- Extension Phase
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	1/61 (1.64%)		0/120 (0.00%)		1/119 (0.84%)		2/220 (0.91%)		1/52 (1.92%)
Serious Adverse Events
	Placebo - Main Phase		Somapacitan - Main Phase		Norditropin - Main Phase		Somapacitan - Extension Phase		Norditropin- Extension Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/61 (8.20%)		7/120 (5.83%)		12/119 (10.08%)		15/220 (6.82%)		3/52 (5.77%)
Blood and lymphatic system disorders
Haemoconcentration † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Cardiac disorders
Cardiogenic shock † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Ventricular extrasystoles † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Ventricular fibrillation † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Endocrine disorders
Adrenocortical insufficiency acute † 1	1/61 (1.64%)	1	1/120 (0.83%)	1	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Diabetes insipidus † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Hypopituitarism † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Secondary adrenocortical insufficiency † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Gastrointestinal disorders
Abdominal pain † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Dental cyst † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Diarrhoea † 1	1/61 (1.64%)	1	0/120 (0.00%)	0	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Inguinal hernia † 1	0/61 (0.00%)	0	1/120 (0.83%)	1	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Pancreatitis acute † 1	1/61 (1.64%)	1	0/120 (0.00%)	0	0/119 (0.00%)	0	0/220 (0.00%)	0	1/52 (1.92%)	1
Stomatitis † 1	0/61 (0.00%)	0	1/120 (0.83%)	1	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Vomiting † 1	1/61 (1.64%)	1	1/120 (0.83%)	1	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
General disorders
Death † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Fatigue † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	2/220 (0.91%)	2	0/52 (0.00%)	0
Non-cardiac chest pain † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Pyrexia † 1	0/61 (0.00%)	0	1/120 (0.83%)	1	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Infections and infestations
Appendicitis † 1	0/61 (0.00%)	0	1/120 (0.83%)	1	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Clostridium difficile infection † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Gastroenteritis † 1	0/61 (0.00%)	0	2/120 (1.67%)	2	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Gastroenteritis viral † 1	1/61 (1.64%)	1	1/120 (0.83%)	1	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Herpes simplex † 1	0/61 (0.00%)	0	1/120 (0.83%)	1	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Influenza † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Pneumonia † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	0/220 (0.00%)	0	1/52 (1.92%)	1
Pneumonia viral † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Sepsis † 1	0/61 (0.00%)	0	1/120 (0.83%)	1	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Urinary tract infection † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	1/52 (1.92%)	1
Urosepsis † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	0/220 (0.00%)	0	1/52 (1.92%)	2
Viral infection † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Viral upper respiratory tract infection † 1	0/61 (0.00%)	0	1/120 (0.83%)	1	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Injury, poisoning and procedural complications
Drug dispensing error † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Fall † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Spinal compression fracture † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Tibia fracture † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Tooth fracture † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Toxicity to various agents † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Investigations
Blood testosterone increased † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Cholangiogram † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Electrocardiogram T wave abnormal † 1	1/61 (1.64%)	1	0/120 (0.00%)	0	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Metabolism and nutrition disorders
Hyponatraemia † 1	1/61 (1.64%)	1	0/120 (0.00%)	0	0/119 (0.00%)	0	0/220 (0.00%)	0	0/52 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Plasma cell myeloma † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Nervous system disorders
Depressed level of consciousness † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Headache † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Psychiatric disorders
Delirium † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Renal and urinary disorders
Chronic kidney disease † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Nephrolithiasis † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Pneumonia aspiration † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Sleep apnoea syndrome † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Skin and subcutaneous tissue disorders
Dermatitis atopic † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	0/52 (0.00%)	0
Surgical and medical procedures
Arterial stent insertion † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Cholecystectomy † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Umbilical hernia repair † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
Vascular disorders
Hypertension † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	0/119 (0.00%)	0	1/220 (0.45%)	1	0/52 (0.00%)	0
1 Term from vocabulary, MedDRA 21; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo - Main Phase		Somapacitan - Main Phase		Norditropin - Main Phase		Somapacitan - Extension Phase		Norditropin- Extension Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/61 (47.54%)		53/120 (44.17%)		55/119 (46.22%)		85/220 (38.64%)		27/52 (51.92%)
Eye disorders
Visual impairment † 1	0/61 (0.00%)	0	0/120 (0.00%)	0	1/119 (0.84%)	1	0/220 (0.00%)	0	3/52 (5.77%)	3
Gastrointestinal disorders
Diarrhoea † 1	5/61 (8.20%)	7	4/120 (3.33%)	5	5/119 (4.20%)	5	14/220 (6.36%)	21	3/52 (5.77%)	3
Nausea † 1	1/61 (1.64%)	1	2/120 (1.67%)	2	6/119 (5.04%)	8	5/220 (2.27%)	14	0/52 (0.00%)	0
General disorders
Fatigue † 1	2/61 (3.28%)	2	3/120 (2.50%)	3	7/119 (5.88%)	7	9/220 (4.09%)	11	0/52 (0.00%)	0
Injection site bruising † 1	2/61 (3.28%)	3	1/120 (0.83%)	1	6/119 (5.04%)	6	0/220 (0.00%)	0	0/52 (0.00%)	0
Oedema peripheral † 1	0/61 (0.00%)	0	5/120 (4.17%)	7	6/119 (5.04%)	8	7/220 (3.18%)	17	1/52 (1.92%)	1
Infections and infestations
Nasopharyngitis † 1	9/61 (14.75%)	12	23/120 (19.17%)	29	20/119 (16.81%)	25	33/220 (15.00%)	41	6/52 (11.54%)	8
Tooth abscess † 1	0/61 (0.00%)	0	1/120 (0.83%)	1	0/119 (0.00%)	0	2/220 (0.91%)	2	3/52 (5.77%)	3
Upper respiratory tract infection † 1	7/61 (11.48%)	7	6/120 (5.00%)	7	9/119 (7.56%)	10	17/220 (7.73%)	18	3/52 (5.77%)	6
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/61 (1.64%)	1	8/120 (6.67%)	8	11/119 (9.24%)	11	7/220 (3.18%)	8	3/52 (5.77%)	4
Back pain † 1	2/61 (3.28%)	2	11/120 (9.17%)	11	4/119 (3.36%)	4	5/220 (2.27%)	7	0/52 (0.00%)	0
Myalgia † 1	3/61 (4.92%)	3	1/120 (0.83%)	1	3/119 (2.52%)	3	5/220 (2.27%)	7	3/52 (5.77%)	3
Nervous system disorders
Headache † 1	10/61 (16.39%)	15	10/120 (8.33%)	45	11/119 (9.24%)	50	25/220 (11.36%)	48	6/52 (11.54%)	23
Skin and subcutaneous tissue disorders
Rash † 1	2/61 (3.28%)	2	3/120 (2.50%)	3	3/119 (2.52%)	4	2/220 (0.91%)	2	3/52 (5.77%)	4
Vascular disorders
Hypertension † 1	1/61 (1.64%)	1	4/120 (3.33%)	4	4/119 (3.36%)	4	3/220 (1.36%)	3	3/52 (5.77%)	3
1 Term from vocabulary, MedDRA 21; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property

Results Point of Contact

• Name/Title: Clinical Reporting Anchor and Disclosure (1452)
• Organization: Novo Nordisk A/S
• Phone: (+1) 866-867-7178
• EMail: clinicaltrials@novonordisk.com

Publications of Results:

Johannsson G, Gordon MB, Hojby Rasmussen M, Hakonsson IH, Karges W, Svaerke C, Tahara S, Takano K, Biller BMK. Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1358-76. doi: 10.1210/clinem/dgaa049.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02229851
• Other Study ID Numbers: NN8640-4054; 2013-002892-16 ( Registry Identifier: European Medicines Agency ); U1111-1145-0211 ( Other Identifier: World Health Organization (WHO) ); JapicCTI-152767 ( Registry Identifier: JAPIC )
• First Submitted: August 26, 2014
• First Posted: September 3, 2014
• Results First Submitted: April 3, 2020
• Results First Posted: July 7, 2020
• Last Update Posted: November 23, 2020