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Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity (STEP 2)

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ClinicalTrials.gov Identifier: NCT03552757
Recruitment Status : Completed
First Posted : June 12, 2018
Results First Posted : August 11, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Obesity
Overweight
Interventions Drug: Semaglutide 1.0 mg
Drug: Semaglutide 2.4 mg
Drug: Placebo I (Semaglutide)
Drug: Placebo II (Semaglutide)
Enrollment 1210
Recruitment Details The trial was conducted at 149 sites in 12 countries as follows: Argentina (5 sites), Canada (10 sites), Germany (9 sites), Greece (6 sites), India (18 sites), Japan (12 sites), Russian Federation (9 sites), South Africa (6 sites), Spain (8 sites), United Arab Emirates (5 sites), United Kingdom (10 sites) and United States (51 sites).
Pre-assignment Details Participants were randomised in 1:1:1 ratio to receive either 'semaglutide 2.4 milligram (mg) and placebo II (placebo matched to semaglutide 1.0 mg) once weekly', 'semaglutide 1.0 mg and placebo I (placebo matched to semaglutide 2.4 mg) once weekly' or 'placebo I and placebo II once weekly'.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description Participants received once-weekly subcutaneous (s.c; under the skin) semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Period Title: Overall Study
Started 403 404 403
Exposed 402 403 402
Full Analysis Set (FAS) 403 404 403
Safety Analysis Set (SAS) 402 403 402
Completed 390 391 383
Not Completed 13 13 20
Reason Not Completed
Withdrawal by Subject             10             5             12
Lost to Follow-up             2             7             7
Death             1             1             1
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo Total
Hide Arm/Group Description Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. Total of all reporting groups
Overall Number of Baseline Participants 403 404 403 1210
Hide Baseline Analysis Population Description
Full analysis set (FAS) which comprised all randomised participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 403 participants 404 participants 403 participants 1210 participants
56  (10) 55  (11) 55  (11) 55  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 404 participants 403 participants 1210 participants
Female
203
  50.4%
223
  55.2%
190
  47.1%
616
  50.9%
Male
200
  49.6%
181
  44.8%
213
  52.9%
594
  49.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 404 participants 403 participants 1210 participants
White
272
  67.5%
237
  58.7%
242
  60.0%
751
  62.1%
Asian
97
  24.1%
112
  27.7%
108
  26.8%
317
  26.2%
Black or African American
28
   6.9%
35
   8.7%
37
   9.2%
100
   8.3%
Other
6
   1.5%
16
   4.0%
13
   3.2%
35
   2.9%
American Indian or Alaska Native
0
   0.0%
4
   1.0%
2
   0.5%
6
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.2%
1
   0.1%
Not Applicable
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 404 participants 403 participants 1210 participants
Not Hispanic or Latino
344
  85.4%
357
  88.4%
354
  87.8%
1055
  87.2%
Hispanic or Latino
59
  14.6%
47
  11.6%
49
  12.2%
155
  12.8%
Not Applicable
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo
Hide Description Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 404 403
Mean (Standard Deviation)
Unit of Measure: Percentage point of body weight
In-trial observation period Number Analyzed 388 participants 376 participants
-9.9  (8.0) -3.3  (5.5)
On-treatment observation period Number Analyzed 351 participants 340 participants
-10.7  (7.8) -3.1  (5.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 2.4 mg, Placebo
Comments Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -6.21
Confidence Interval (2-Sided) 95%
-7.28 to -5.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 2.4 mg, Placebo
Comments Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -7.57
Confidence Interval (2-Sided) 95%
-8.56 to -6.58
Estimation Comments [Not Specified]
2.Primary Outcome
Title Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo
Hide Description Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 404 403
Measure Type: Count of Participants
Unit of Measure: Participants
In-trial observation period Number Analyzed 388 participants 376 participants
Yes
267
  68.8%
107
  28.5%
No
121
  31.2%
269
  71.5%
On-treatment observation period Number Analyzed 351 participants 340 participants
Yes
257
  73.2%
94
  27.6%
No
94
  26.8%
246
  72.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 2.4 mg, Placebo
Comments Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.88
Confidence Interval (2-Sided) 95%
3.58 to 6.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 2.4 mg, Placebo
Comments Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.69
Confidence Interval (2-Sided) 95%
6.31 to 11.97
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg
Hide Description Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Semaglutide 1.0 mg
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 388 380
Mean (Standard Deviation)
Unit of Measure: Percentage point of body weight
-9.9  (8.0) -7.2  (6.6)
4.Secondary Outcome
Title Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg
Hide Description Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Semaglutide 1.0 mg
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 388 380
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
267
  68.8%
217
  57.1%
No
121
  31.2%
163
  42.9%
5.Secondary Outcome
Title Change in Waist Circumference
Hide Description Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 380 387 375
Mean (Standard Deviation)
Unit of Measure: Centimetre (cm)
-6.9  (6.8) -9.7  (8.1) -4.3  (6.5)
6.Secondary Outcome
Title Change in Body Weight (Kg)
Hide Description Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 380 388 376
Mean (Standard Deviation)
Unit of Measure: Kilogram (kg)
-7.1  (6.7) -9.9  (8.5) -3.4  (6.2)
7.Secondary Outcome
Title Change in BMI
Hide Description Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 380 388 376
Mean (Standard Deviation)
Unit of Measure: kilogram per square meter (kg/m^2)
-2.6  (2.4) -3.6  (3.1) -1.2  (2.1)
8.Secondary Outcome
Title Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%
Hide Description Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 380 388 376
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
109
  28.7%
177
  45.6%
31
   8.2%
No
271
  71.3%
211
  54.4%
345
  91.8%
9.Secondary Outcome
Title Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%
Hide Description Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 380 388 376
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
52
  13.7%
100
  25.8%
12
   3.2%
No
328
  86.3%
288
  74.2%
364
  96.8%
10.Secondary Outcome
Title Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%
Hide Description Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 380 388 376
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
18
   4.7%
51
  13.1%
6
   1.6%
No
362
  95.3%
337
  86.9%
370
  98.4%
11.Secondary Outcome
Title Change in HbA1c (%)
Hide Description Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 376 381 374
Mean (Standard Deviation)
Unit of Measure: Percentage point of HbA1c
-1.5  (1.1) -1.7  (1.2) -0.3  (1.3)
12.Secondary Outcome
Title Change in HbA1c (mmol/Mol)
Hide Description Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 376 381 374
Mean (Standard Deviation)
Unit of Measure: millimoles per mole (mmol/mol)
-16.9  (12.3) -18.7  (13.0) -3.4  (14.3)
13.Secondary Outcome
Title Change in FPG (mg/dL)
Hide Description Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 367 375 370
Mean (Standard Deviation)
Unit of Measure: milligrams per deciliter (mg/dL)
-36.5  (45.1) -37.9  (45.9) -2.3  (53.1)
14.Secondary Outcome
Title Change in Fasting Serum Insulin
Hide Description Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 352 360 351
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picomoles per litre (pmol/L)
0.94
(59.8%)
0.90
(65.4%)
0.93
(53.6%)
15.Secondary Outcome
Title Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)
Hide Description Number of participants who achieved HbA1c <7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 376 381 374
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
272
  72.3%
299
  78.5%
99
  26.5%
No
104
  27.7%
82
  21.5%
275
  73.5%
16.Secondary Outcome
Title Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)
Hide Description Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 376 381 374
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
226
  60.1%
257
  67.5%
58
  15.5%
No
150
  39.9%
124
  32.5%
316
  84.5%
17.Secondary Outcome
Title Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%
Hide Description Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 376 381 374
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
105
  27.9%
170
  44.6%
25
   6.7%
No
271
  72.1%
211
  55.4%
349
  93.3%
18.Secondary Outcome
Title Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%
Hide Description Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 376 381 374
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
49
  13.0%
98
  25.7%
11
   2.9%
No
327
  87.0%
283
  74.3%
363
  97.1%
19.Secondary Outcome
Title Change in Systolic Blood Pressure
Hide Description Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 379 387 376
Mean (Standard Deviation)
Unit of Measure: Millimetre of mercury (mmHg)
-3  (15) -4  (14) 0  (15)
20.Secondary Outcome
Title Change in Diastolic Blood Pressure
Hide Description Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 379 387 376
Mean (Standard Deviation)
Unit of Measure: Millimetre of mercury (mmHg)
-1  (9) -2  (9) -1  (9)
21.Secondary Outcome
Title Change in Total Cholesterol
Hide Description Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 372 380 373
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of total cholesterol
0.97
(20.1%)
0.99
(17.9%)
1.00
(18.9%)
22.Secondary Outcome
Title Change in HDL Cholesterol
Hide Description Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 372 375 369
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HDL cholesterol
1.06
(16.0%)
1.07
(15.7%)
1.04
(15.3%)
23.Secondary Outcome
Title Change in LDL Cholesterol
Hide Description Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 372 380 373
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of LDL cholesterol
0.99
(37.5%)
1.00
(30.9%)
1.00
(28.9%)
24.Secondary Outcome
Title Change in VLDL Cholesterol
Hide Description Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 372 380 373
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of VLDL cholesterol
0.82
(42.1%)
0.80
(42.0%)
0.92
(40.5%)
25.Secondary Outcome
Title Change in Free Fatty Acids
Hide Description Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 353 361 354
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of free fatty acids
0.85
(61.4%)
0.84
(68.7%)
1.01
(62.3%)
26.Secondary Outcome
Title Change in Triglycerides
Hide Description Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 372 380 373
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of triglycerides
0.81
(44.5%)
0.79
(43.8%)
0.92
(44.5%)
27.Secondary Outcome
Title Change in hsCRP
Hide Description Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 372 380 373
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of hsCRP
0.59
(115.7%)
0.50
(125.7%)
0.84
(90.9%)
28.Secondary Outcome
Title Change in PAI-1 Activity
Hide Description Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 334 353 336
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of PAI-1 activity
1.21
(73.7%)
1.06
(80.8%)
1.42
(68.9%)
29.Secondary Outcome
Title Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)
Hide Description SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 370 376 365
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.1  (6.8) 2.8  (7.7) 0.8  (7.0)
30.Secondary Outcome
Title Change in SF-36 (All Scores Except Physical Functioning)
Hide Description SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 370 376 365
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Role-Physical 0.6  (6.9) 0.8  (7.4) 0.0  (7.1)
Bodily Pain 0.4  (8.3) 0.3  (9.0) -0.4  (8.6)
General Health 1.7  (7.2) 2.2  (7.3) 0.6  (7.5)
Vitality -0.1  (7.8) 0.8  (7.9) -0.9  (7.9)
Social Functioning -0.3  (6.6) 0.2  (6.6) -0.7  (7.4)
Role-Emotional -0.4  (7.3) -0.4  (7.7) -1.1  (7.8)
Mental Health -0.9  (7.5) -0.4  (6.9) -1.6  (7.5)
Physical component summary 1.9  (6.4) 2.3  (7.2) 0.9  (6.6)
Mental component summary -1.4  (7.4) -0.9  (6.9) -1.8  (7.6)
31.Secondary Outcome
Title Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)
Hide Description The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 369 376 365
Mean (Standard Deviation)
Unit of Measure: Score on a scale
8.5  (18.8) 11.4  (20.8) 4.9  (20.4)
32.Secondary Outcome
Title Change in IWQOL-Lite for CT (All Scores Except Physical Function)
Hide Description The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 369 376 365
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Physical 7.6  (18.0) 11.0  (19.6) 4.4  (19.1)
Psychosocial 8.6  (15.7) 9.6  (16.7) 5.6  (16.5)
Total 8.2  (14.8) 10.1  (15.9) 5.2  (15.5)
33.Secondary Outcome
Title Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
Hide Description The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 370 376 365
Measure Type: Count of Participants
Unit of Measure: Participants
Yes (with threshold 4.3)
88
  23.8%
111
  29.5%
68
  18.6%
No (with threshold 4.3)
282
  76.2%
265
  70.5%
297
  81.4%
Yes (with threshold 3.7)
130
  35.1%
158
  42.0%
102
  27.9%
No (with threshold 3.7)
240
  64.9%
218
  58.0%
263
  72.1%
34.Secondary Outcome
Title Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score
Hide Description The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
Time Frame At week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 369 376 365
Measure Type: Count of Participants
Unit of Measure: Participants
Yes (with threshold 20)
107
  29.0%
131
  34.8%
83
  22.7%
No (with threshold 20)
262
  71.0%
245
  65.2%
282
  77.3%
Yes (with threshold 14.6)
144
  39.0%
160
  42.6%
113
  31.0%
No (with threshold 14.6)
225
  61.0%
216
  57.4%
252
  69.0%
35.Secondary Outcome
Title Number of TEAEs - Semaglutide 2.4 mg Versus Placebo
Hide Description Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
Time Frame Week 0 to week 75
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 403 402
Measure Type: Number
Unit of Measure: Events
2197 1388
36.Secondary Outcome
Title Number of SAEs - Semaglutide 2.4 mg Versus Placebo
Hide Description Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
Time Frame Week 0 to week 75
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 403 402
Measure Type: Number
Unit of Measure: Events
71 53
37.Secondary Outcome
Title Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo
Hide Description Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time Frame Week 0 to week 75
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 403 402
Measure Type: Number
Unit of Measure: Episodes
51 18
38.Secondary Outcome
Title Change in Pulse - Semaglutide 2.4 mg Versus Placebo
Hide Description Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 351 340
Mean (Standard Deviation)
Unit of Measure: Beats/minute
2  (9) 0  (9)
39.Secondary Outcome
Title Change in Amylase - Semaglutide 2.4 mg Versus Placebo
Hide Description Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 350 338
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of amylase
1.24
(28.3%)
1.06
(25.0%)
40.Secondary Outcome
Title Change in Lipase - Semaglutide 2.4 mg Versus Placebo
Hide Description Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 350 338
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of lipase
1.41
(57.2%)
0.99
(51.8%)
41.Secondary Outcome
Title Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo
Hide Description Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Number of Participants Analyzed 348 339
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of calcitonin
0.94
(60.3%)
0.96
(38.6%)
Time Frame Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.
Adverse Event Reporting Description All presented AEs are treatment-emergent (i.e., TEAEs).
 
Arm/Group Title Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Hide Arm/Group Description Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity. Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
All-Cause Mortality
Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/402 (0.25%)      1/403 (0.25%)      1/402 (0.25%)    
Hide Serious Adverse Events
Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/402 (7.71%)      40/403 (9.93%)      37/402 (9.20%)    
Cardiac disorders       
Acute myocardial infarction  1  2/402 (0.50%)  2 1/403 (0.25%)  1 1/402 (0.25%)  1
Angina pectoris  1  1/402 (0.25%)  1 0/403 (0.00%)  0 1/402 (0.25%)  1
Angina unstable  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Atrial fibrillation  1  2/402 (0.50%)  2 2/403 (0.50%)  2 2/402 (0.50%)  2
Bradycardia  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Cardiac failure acute  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Cardiac failure congestive  1  1/402 (0.25%)  1 1/403 (0.25%)  1 1/402 (0.25%)  1
Myocardial infarction  1  1/402 (0.25%)  1 1/403 (0.25%)  1 0/402 (0.00%)  0
Myocardial ischaemia  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Supraventricular tachycardia  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Eye disorders       
Cataract  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Glaucoma  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  3/402 (0.75%)  3 0/403 (0.00%)  0 0/402 (0.00%)  0
Diarrhoea  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Diverticular perforation  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Food poisoning  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Gastric ulcer  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Gastritis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Inguinal hernia  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Nausea  1  2/402 (0.50%)  2 1/403 (0.25%)  1 0/402 (0.00%)  0
Obstructive pancreatitis  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Small intestinal obstruction  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Vomiting  1  0/402 (0.00%)  0 2/403 (0.50%)  2 0/402 (0.00%)  0
General disorders       
Chest pain  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Hepatobiliary disorders       
Cholecystitis acute  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Cholecystitis chronic  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Cholelithiasis  1  1/402 (0.25%)  1 1/403 (0.25%)  1 0/402 (0.00%)  0
Non-alcoholic steatohepatitis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Immune system disorders       
Immunisation reaction  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Infections and infestations       
Appendicitis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 1/402 (0.25%)  1
Bronchitis  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Cellulitis  1  2/402 (0.50%)  2 0/403 (0.00%)  0 1/402 (0.25%)  1
Colonic abscess  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Cystitis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Diverticulitis  1  1/402 (0.25%)  1 0/403 (0.00%)  0 1/402 (0.25%)  1
Empyema  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Gastroenteritis  1  3/402 (0.75%)  3 3/403 (0.74%)  3 1/402 (0.25%)  1
Herpes zoster  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Joint abscess  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Kidney infection  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Osteomyelitis  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Pharyngitis streptococcal  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Pneumonia  1  1/402 (0.25%)  1 1/403 (0.25%)  1 2/402 (0.50%)  2
Pneumonia influenzal  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Postoperative wound infection  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Respiratory tract infection  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Sepsis  1  3/402 (0.75%)  3 0/403 (0.00%)  0 0/402 (0.00%)  0
Urosepsis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Viral infection  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Wound infection staphylococcal  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Injury, poisoning and procedural complications       
Anaemia postoperative  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Ankle fracture  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Cervical vertebral fracture  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Fall  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Hip fracture  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Humerus fracture  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Joint dislocation  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Ligament rupture  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Lisfranc fracture  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Post procedural haemorrhage  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Rib fracture  1  0/402 (0.00%)  0 2/403 (0.50%)  2 0/402 (0.00%)  0
Road traffic accident  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Skin laceration  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Spinal compression fracture  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Subdural haematoma  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Thoracic vertebral fracture  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Traumatic haemothorax  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Upper limb fracture  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Metabolism and nutrition disorders       
Cachexia  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Decreased appetite  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Dehydration  1  2/402 (0.50%)  2 1/403 (0.25%)  1 1/402 (0.25%)  1
Diabetes mellitus inadequate control  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Diabetic ketoacidosis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Diabetic metabolic decompensation  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Hyperglycaemia  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Hyponatraemia  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Ketoacidosis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Lactic acidosis  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Obesity  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Musculoskeletal and connective tissue disorders       
Neuropathic arthropathy  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Osteoarthritis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Pain in extremity  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Rotator cuff syndrome  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Spondylolisthesis  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Trigger finger  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma gastric  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Adenocarcinoma of colon  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Gastric cancer  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Gastric cancer stage IV  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Gastrointestinal lymphoma  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Gastrointestinal stromal tumour  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Hepatocellular carcinoma  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Invasive ductal breast carcinoma  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Keratinising squamous cell carcinoma of nasopharynx  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Myeloid leukaemia  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Neuroendocrine tumour  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Prostate cancer  1  0/402 (0.00%)  0 0/403 (0.00%)  0 2/402 (0.50%)  2
Uterine cancer  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Nervous system disorders       
Cerebral artery thrombosis  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Cerebral infarction  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Cerebrovascular accident  1  0/402 (0.00%)  0 1/403 (0.25%)  1 1/402 (0.25%)  1
Hepatic encephalopathy  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Hyperaesthesia  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Hyponatraemic encephalopathy  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Ischaemic stroke  1  1/402 (0.25%)  1 0/403 (0.00%)  0 1/402 (0.25%)  1
Presyncope  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Spinal epidural haematoma  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Subarachnoid haemorrhage  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Syncope  1  1/402 (0.25%)  1 1/403 (0.25%)  1 0/402 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Renal and urinary disorders       
Acute kidney injury  1  2/402 (0.50%)  2 2/403 (0.50%)  3 1/402 (0.25%)  1
Bladder outlet obstruction  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Stag horn calculus  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Ureterolithiasis  1  0/402 (0.00%)  0 0/403 (0.00%)  0 2/402 (0.50%)  2
Reproductive system and breast disorders       
Uterine polyp  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  1/402 (0.25%)  1 1/403 (0.25%)  1 0/402 (0.00%)  0
Asthma  1  0/402 (0.00%)  0 1/403 (0.25%)  1 1/402 (0.25%)  1
Pneumothorax  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Surgical and medical procedures       
Cardiac pacemaker replacement  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
Sperm aspiration  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Stent placement  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Thyroidectomy  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Vascular disorders       
Aortic rupture  1  0/402 (0.00%)  0 1/403 (0.25%)  1 0/402 (0.00%)  0
Hypertension  1  0/402 (0.00%)  0 2/403 (0.50%)  2 0/402 (0.00%)  0
Hypertensive urgency  1  0/402 (0.00%)  0 0/403 (0.00%)  0 1/402 (0.25%)  1
Shock  1  1/402 (0.25%)  1 0/403 (0.00%)  0 0/402 (0.00%)  0
1
Term from vocabulary, MedDRA 22
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Semaglutide 1.0 mg Semaglutide 2.4 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   261/402 (64.93%)      284/403 (70.47%)      190/402 (47.26%)    
Gastrointestinal disorders       
Abdominal distension  1  9/402 (2.24%)  12 24/403 (5.96%)  30 11/402 (2.74%)  13
Constipation  1  51/402 (12.69%)  70 70/403 (17.37%)  82 22/402 (5.47%)  26
Diarrhoea  1  88/402 (21.89%)  157 86/403 (21.34%)  141 48/402 (11.94%)  66
Dyspepsia  1  27/402 (6.72%)  27 25/403 (6.20%)  30 5/402 (1.24%)  5
Flatulence  1  21/402 (5.22%)  25 16/403 (3.97%)  21 7/402 (1.74%)  9
Nausea  1  128/402 (31.84%)  196 135/403 (33.50%)  248 37/402 (9.20%)  45
Vomiting  1  54/402 (13.43%)  93 86/403 (21.34%)  186 11/402 (2.74%)  12
General disorders       
Fatigue  1  19/402 (4.73%)  26 28/403 (6.95%)  29 4/402 (1.00%)  4
Infections and infestations       
Gastroenteritis  1  21/402 (5.22%)  25 11/403 (2.73%)  12 12/402 (2.99%)  14
Nasopharyngitis  1  47/402 (11.69%)  69 68/403 (16.87%)  115 59/402 (14.68%)  92
Upper respiratory tract infection  1  37/402 (9.20%)  54 42/403 (10.42%)  48 38/402 (9.45%)  50
Metabolism and nutrition disorders       
Decreased appetite  1  29/402 (7.21%)  33 38/403 (9.43%)  41 15/402 (3.73%)  17
Musculoskeletal and connective tissue disorders       
Arthralgia  1  24/402 (5.97%)  27 23/403 (5.71%)  29 20/402 (4.98%)  20
Back pain  1  28/402 (6.97%)  30 27/403 (6.70%)  30 14/402 (3.48%)  15
Nervous system disorders       
Headache  1  33/402 (8.21%)  48 31/403 (7.69%)  40 20/402 (4.98%)  27
1
Term from vocabulary, MedDRA 22
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Clinical Transparency Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03552757    
Other Study ID Numbers: NN9536-4374
U1111-1200-8148 ( Other Identifier: World Health Organization (WHO) )
2017-003414-10 ( Other Identifier: European Medicines Agency (EudraCT) )
First Submitted: May 30, 2018
First Posted: June 12, 2018
Results First Submitted: June 16, 2021
Results First Posted: August 11, 2021
Last Update Posted: November 9, 2021