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STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 1)

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ClinicalTrials.gov Identifier: NCT03548935
Recruitment Status : Completed
First Posted : June 7, 2018
Results First Posted : August 11, 2021
Last Update Posted : November 19, 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 Metabolism and Nutrition Disorder
Overweight or Obesity
Interventions Drug: Semaglutide
Drug: Placebo (semaglutide)
Enrollment 1961
Recruitment Details The trial was conducted at 129 sites in 16 countries as follows (all sites screened and randomized): Argentina (5 sites), Belgium (5 sites), Bulgaria (5 sites), Canada (7 sites), Denmark (1 site), Finland (2 sites), France (7 sites), Germany (13 sites), India (13 sites), Japan (5 sites), Mexico (3 sites), Poland (4 sites), Russian Federation (8 sites), Taiwan(1 site), UK (10 sites), US (40 sites).
Pre-assignment Details The trial included an initial 16-week dose-escalation period and a 52-week dose maintenance period. Participants were randomized in 2:1 ratio either to receive semaglutide 2.4 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Period Title: Overall Study
Started 1306 655
Full Analysis Set (FAS) 1306 655
Safety Analysis Set (SAS) 1306 655
Completed 1240 609
Not Completed 66 46
Reason Not Completed
Withdrawal by Subject             26             17
Lost to Follow-up             39             28
Death             1             1
Arm/Group Title Semaglutide 2.4 mg Placebo Total
Hide Arm/Group Description Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. Total of all reporting groups
Overall Number of Baseline Participants 1306 655 1961
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1306 participants 655 participants 1961 participants
46  (13) 47  (12) 46  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1306 participants 655 participants 1961 participants
Female
955
  73.1%
498
  76.0%
1453
  74.1%
Male
351
  26.9%
157
  24.0%
508
  25.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1306 participants 655 participants 1961 participants
Hispanic or Latino
150
  11.5%
86
  13.1%
236
  12.0%
Not Hispanic or Latino
1118
  85.6%
551
  84.1%
1669
  85.1%
Unknown or Not Reported
38
   2.9%
18
   2.7%
56
   2.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1306 participants 655 participants 1961 participants
American Indian or Alaska Native
17
   1.3%
10
   1.5%
27
   1.4%
Asian
181
  13.9%
80
  12.2%
261
  13.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.3%
2
   0.1%
Black or African American
72
   5.5%
39
   6.0%
111
   5.7%
White
973
  74.5%
499
  76.2%
1472
  75.1%
More than one race
25
   1.9%
8
   1.2%
33
   1.7%
Unknown or Not Reported
38
   2.9%
17
   2.6%
55
   2.8%
1.Primary Outcome
Title Change in Body Weight (%)
Hide Description Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1306 655
Mean (Standard Deviation)
Unit of Measure: Percentage point
In-trial observation period Number Analyzed 1212 participants 577 participants
-15.6  (10.1) -2.8  (6.5)
On-treatment observation period Number Analyzed 1059 participants 499 participants
-16.9  (9.4) -3.1  (6.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 2.4 mg, Placebo
Comments Treatment policy estimand
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -12.44
Confidence Interval (2-Sided) 95%
-13.37 to -11.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 2.4 mg, Placebo
Comments Hypothetical estimand
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 -14.42
Confidence Interval (2-Sided) 95%
-15.29 to -13.55
Estimation Comments [Not Specified]
2.Primary Outcome
Title Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)
Hide Description Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.
Time Frame After week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1306 655
Measure Type: Count of Participants
Unit of Measure: Participants
In-trial observation period Number Analyzed 1212 participants 577 participants
Yes
1047
  86.4%
182
  31.5%
No
165
  13.6%
395
  68.5%
On-treatment observation period Number Analyzed 1059 participants 499 participants
Yes
978
  92.4%
165
  33.1%
No
81
   7.6%
334
  66.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 2.4 mg, Placebo
Comments Treatment policy estimand
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 11.22
Confidence Interval (2-Sided) 95%
8.88 to 14.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 2.4 mg, Placebo
Comments Hypothetical estimand
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 37.03
Confidence Interval (2-Sided) 95%
28.02 to 48.95
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)
Hide Description Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).
Time Frame Week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1212 577
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
838
  69.1%
69
  12.0%
No
374
  30.9%
508
  88.0%
4.Secondary Outcome
Title Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)
Hide Description Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1212 577
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
612
  50.5%
28
   4.9%
No
600
  49.5%
549
  95.1%
5.Secondary Outcome
Title Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)
Hide Description Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1212 577
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
388
  32.0%
10
   1.7%
No
824
  68.0%
567
  98.3%
6.Secondary Outcome
Title Change in Waist Circumference (cm)
Hide Description Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1210 575
Mean (Standard Deviation)
Unit of Measure: Centimeter (cm)
-14.1  (9.6) -4.4  (6.9)
7.Secondary Outcome
Title Change in Systolic Blood Pressure (mmHg)
Hide Description Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1210 574
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
-7  (14) -1  (13)
8.Secondary Outcome
Title Change in Short Form 36 (SF-36)
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 eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. 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. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1195 566
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Change in physical functioning score (SF-36) 2.3  (6.6) 0.4  (7.4)
Change in SF-36 (role-physical score) 1.1  (7.2) -0.2  (7.2)
Change in SF-36 (bodily pain score) 0.5  (8.2) -1.3  (8.9)
Change in SF-36 (general health score) 2.0  (7.2) -0.6  (7.1)
Change in SF-36 (vitality score) 0.7  (8.0) -1.3  (7.9)
Change in SF-36 (social functioning score) -0.3  (6.6) -1.4  (7.4)
Change in SF-36 (role-emotional score) -0.9  (7.3) -1.5  (7.6)
Change in SF-36 (mental health score) -0.8  (7.0) -1.7  (7.4)
Change in SF-36 (physical component summary) 2.4  (6.7) 0.2  (7.1)
Change in SF-36 (mental component summary) -1.5  (7.1) -2.1  (7.7)
9.Secondary Outcome
Title Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score
Hide Description IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1193 566
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Change in physical function domain score 15.0  (21.6) 6.0  (21.1)
Change in physical domain score 14.0  (20.0) 5.0  (19.5)
Change in psychosocial domain score 17.4  (19.2) 6.9  (17.8)
Change in total score 16.2  (17.8) 6.3  (16.8)
10.Secondary Outcome
Title Change in Body Weight (kg)
Hide Description Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1212 577
Mean (Standard Deviation)
Unit of Measure: Kilogram (kg)
-16.1  (10.6) -2.9  (7.2)
11.Secondary Outcome
Title Change in Body Mass Index (BMI) (kg/m2)
Hide Description Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1212 577
Mean (Standard Deviation)
Unit of Measure: Kilogram per square meter (kg/sqm)
-5.8  (3.8) -1.0  (2.5)
12.Secondary Outcome
Title Change in HbA1C (%)
Hide Description Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1197 563
Mean (Standard Deviation)
Unit of Measure: Percentage point of HbA1c
-0.5  (0.3) -0.2  (0.3)
13.Secondary Outcome
Title Change in HbA1C (mmol/Mol)
Hide Description Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1197 563
Mean (Standard Deviation)
Unit of Measure: millimoles per mole (mmol/mol)
-5.1  (3.3) -1.8  (3.0)
14.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) (mg/dL)
Hide Description Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1175 557
Mean (Standard Deviation)
Unit of Measure: milligrams per deciliter (mg/dL)
-9.2  (10.9) -0.4  (12.7)
15.Secondary Outcome
Title Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline
Hide Description Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline. Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1147 550
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of fasting serum insulin
0.73
(62.3%)
0.92
(56.5%)
16.Secondary Outcome
Title Change in Diastolic Blood Pressure (mmHg)
Hide Description Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1210 574
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
-3  (9) -1  (9)
17.Secondary Outcome
Title Change in Total Cholesterol (mg/dL) - Ratio to Baseline
Hide Description Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1196 561
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of total cholesterol
0.96
(14.8%)
1.00
(15.5%)
18.Secondary Outcome
Title Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline
Hide Description Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1192 558
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HDL cholesterol
1.05
(16.1%)
1.02
(14.9%)
19.Secondary Outcome
Title Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline
Hide Description Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1194 561
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of LDL cholesterol
0.97
(23.7%)
1.01
(25.5%)
20.Secondary Outcome
Title Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline
Hide Description Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1193 561
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of VLDL cholesterol
0.77
(37.7%)
0.92
(35.2%)
21.Secondary Outcome
Title Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Hide Description Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1154 552
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of free fatty acids
0.83
(78.3%)
0.93
(70.8%)
22.Secondary Outcome
Title Change in Triglycerides (mg/dL) - Ratio to Baseline
Hide Description Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1194 561
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of triglycerides
0.77
(38.3%)
0.92
(36.2%)
23.Secondary Outcome
Title Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline
Hide Description Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1200 562
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of hsCRP
0.45
(128.2%)
0.84
(102.5%)
24.Secondary Outcome
Title Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline
Hide Description Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1131 546
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of PAI-1
1.15
(86.5%)
1.53
(77.3%)
25.Secondary Outcome
Title Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline
Hide Description Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1194 562
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of soluble leptin receptor
1.07
(24.9%)
1.02
(22.2%)
26.Secondary Outcome
Title Change in Leptin (ng/mL) - Ratio to Baseline
Hide Description Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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 Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1197 563
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of leptin
0.52
(75.9%)
0.87
(52.7%)
27.Secondary Outcome
Title Change in Body Composition (Total Fat Mass) (%)
Hide Description Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 83 39
Mean (Standard Deviation)
Unit of Measure: Percentage point
-3.9  (5.4) -0.3  (2.8)
28.Secondary Outcome
Title Change in Body Composition (Total Fat Mass) (kg)
Hide Description Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 83 39
Mean (Standard Deviation)
Unit of Measure: Kilograms
-9.3  (8.5) -1.5  (5.1)
29.Secondary Outcome
Title Change in Body Composition (Lean Body Mass) (%)
Hide Description Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 83 39
Mean (Standard Deviation)
Unit of Measure: Percentage point
3.4  (5.1) 0.2  (2.7)
30.Secondary Outcome
Title Change in Body Composition (Lean Body Mass) (kg)
Hide Description Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 83 39
Mean (Standard Deviation)
Unit of Measure: Kilograms
-5.8  (4.6) -1.8  (2.5)
31.Secondary Outcome
Title Change in Body Composition (Visceral Fat Mass) (%)
Hide Description Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 83 39
Mean (Standard Deviation)
Unit of Measure: Percentage point
-2.2  (4.4) -0.1  (4.5)
32.Secondary Outcome
Title Change in Body Composition (Visceral Fat Mass) (kg)
Hide Description Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 83 39
Mean (Standard Deviation)
Unit of Measure: Kilograms
-0.4  (0.3) -0.1  (0.3)
33.Secondary Outcome
Title Change in Body Weight (%) - DEXA Subpopulation
Hide Description Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 89 42
Mean (Standard Deviation)
Unit of Measure: Percentage point
-15.8  (11.1) -3.4  (6.1)
34.Secondary Outcome
Title Change in Body Weight (kg) - DEXA Subpopulation
Hide Description Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 89 42
Mean (Standard Deviation)
Unit of Measure: Kilograms
-15.5  (11.4) -3.2  (6.1)
35.Secondary Outcome
Title Participants Who Achieve "Responder Definition Value" (Yes/no) 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 different 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 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 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 is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
Time Frame After week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1195 566
Measure Type: Count of Participants
Unit of Measure: Participants
Yes (with threshold 4.3)
318
  26.6%
97
  17.1%
No (with threshold 4.3)
877
  73.4%
469
  82.9%
Yes (with threshold 3.7)
478
  40.0%
153
  27.0%
No (with threshold 3.7)
717
  60.0%
413
  73.0%
36.Secondary Outcome
Title Participants Who Achieve "Responder Definition Value" (Yes/no) 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. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
Time Frame After week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1193 566
Measure Type: Count of Participants
Unit of Measure: Participants
Yes (with threshold 20)
473
  39.6%
145
  25.6%
No (with threshold 20)
720
  60.4%
421
  74.4%
Yes (with threshold 14.6)
611
  51.2%
186
  32.9%
No (with threshold 14.6)
582
  48.8%
380
  67.1%
37.Secondary Outcome
Title Number of Treatment Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
Time Frame Baseline (week 0) to week 75
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least one dose of trial product.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1306 655
Measure Type: Number
Unit of Measure: Events
9658 3302
38.Secondary Outcome
Title Number of Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
Time Frame Baseline (week 0) to week 75
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least one dose of trial product.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1306 655
Measure Type: Number
Unit of Measure: Events
164 53
39.Secondary Outcome
Title Change in Pulse
Hide Description Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1059 499
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
3  (10) -1  (10)
40.Secondary Outcome
Title Change in Amylase - Ratio to Baseline
Hide Description Change in amylase (measured as units per litre [U/L]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1053 497
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of amylase
1.14
(21.6%)
1.03
(21.4%)
41.Secondary Outcome
Title Change in Lipase - Ratio to Baseline
Hide Description Change in lipase (measured as units per litre [U/L]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1053 496
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of lipase
1.41
(49.3%)
0.97
(37.3%)
42.Secondary Outcome
Title Change in Calcitonin - Ratio to Baseline
Hide Description Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time Frame Baseline (week 0) to week 68
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Semaglutide 2.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Number of Participants Analyzed 1050 497
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of calcitonin
0.99
(37.6%)
0.95
(40.9%)
Time Frame week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of Semaglutide or placebo.
Adverse Event Reporting Description All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomized treatment and no later than the date of last dose + 7 weeks.
 
Arm/Group Title Sema 2.4 mg Placebo
Hide Arm/Group Description Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
All-Cause Mortality
Sema 2.4 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1306 (0.08%)      1/655 (0.15%)    
Hide Serious Adverse Events
Sema 2.4 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   128/1306 (9.80%)      42/655 (6.41%)    
Blood and lymphatic system disorders     
Anaemia  1  2/1306 (0.15%)  2 0/655 (0.00%)  0
Splenic haemorrhage  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  2/1306 (0.15%)  2 1/655 (0.15%)  1
Angina pectoris  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Angina unstable  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Atrial fibrillation  1  2/1306 (0.15%)  4 1/655 (0.15%)  1
Atrial tachycardia  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Cardiomyopathy  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Coronary artery stenosis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Myocardial infarction  1  0/1306 (0.00%)  0 2/655 (0.31%)  2
Myocarditis  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Palpitations  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Ear and labyrinth disorders     
Meniere's disease  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Vertigo  1  3/1306 (0.23%)  3 0/655 (0.00%)  0
Eye disorders     
Diplopia  1  1/1306 (0.08%)  2 0/655 (0.00%)  0
Optic ischaemic neuropathy  1  2/1306 (0.15%)  2 0/655 (0.00%)  0
Gastrointestinal disorders     
Abdominal hernia  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Abdominal pain  1  3/1306 (0.23%)  3 0/655 (0.00%)  0
Abdominal pain lower  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Anal fistula  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Colitis  1  2/1306 (0.15%)  2 0/655 (0.00%)  0
Colitis ischaemic  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Constipation  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Diarrhoea  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Duodenal ulcer  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Enteritis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Hiatus hernia  1  2/1306 (0.15%)  2 0/655 (0.00%)  0
Large intestine perforation  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Nausea  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Oesophageal achalasia  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Pancreatitis acute  1  2/1306 (0.15%)  2 0/655 (0.00%)  0
Volvulus  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Vomiting  1  4/1306 (0.31%)  4 0/655 (0.00%)  0
General disorders     
Chest pain  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Non-cardiac chest pain  1  2/1306 (0.15%)  2 0/655 (0.00%)  0
Pyrexia  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Vascular stent occlusion  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Cholecystitis  1  4/1306 (0.31%)  4 0/655 (0.00%)  0
Cholecystitis acute  1  3/1306 (0.23%)  3 0/655 (0.00%)  0
Cholelithiasis  1  12/1306 (0.92%)  12 1/655 (0.15%)  1
Hypertransaminasaemia  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Infections and infestations     
Acute sinusitis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Appendicitis  1  5/1306 (0.38%)  5 1/655 (0.15%)  1
Appendicitis perforated  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Arthritis infective  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Bacterial colitis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Cellulitis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Chronic sinusitis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Cytomegalovirus infection  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Device related infection  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Empyema  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Gastroenteritis  1  5/1306 (0.38%)  5 0/655 (0.00%)  0
Gastroenteritis astroviral  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Hepatitis E  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Large intestine infection  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Meningitis viral  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Neutropenic sepsis  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Pneumonia  1  0/1306 (0.00%)  0 2/655 (0.31%)  2
Pyelonephritis  1  2/1306 (0.15%)  2 0/655 (0.00%)  0
Respiratory syncytial virus infection  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Respiratory tract infection  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Septic shock  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Sinusitis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Staphylococcal infection  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Staphylococcal sepsis  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Subcutaneous abscess  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Tonsillitis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Toxoplasmosis  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Urinary tract infection  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  1/1306 (0.08%)  1 1/655 (0.15%)  1
Femur fracture  1  1/1306 (0.08%)  2 0/655 (0.00%)  0
Gun shot wound  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Ligament rupture  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Meniscus injury  1  1/1306 (0.08%)  1 1/655 (0.15%)  1
Post procedural haemorrhage  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Procedural haemorrhage  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Radius fracture  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Rib fracture  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Road traffic accident  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Subdural haematoma  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Thoracic vertebral fracture  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Tibia fracture  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Investigations     
Lipase increased  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Weight increased  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Metabolism and nutrition disorders     
Gout  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Hypokalaemia  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthropathy  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Back pain  1  1/1306 (0.08%)  1 1/655 (0.15%)  1
Costochondritis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Intervertebral disc degeneration  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Intervertebral disc protrusion  1  1/1306 (0.08%)  1 1/655 (0.15%)  1
Muscular weakness  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Musculoskeletal chest pain  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Musculoskeletal pain  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Myalgia intercostal  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Osteoarthritis  1  3/1306 (0.23%)  3 2/655 (0.31%)  2
Rotator cuff syndrome  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma stage 0  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Gastrointestinal stromal tumour  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Glioblastoma  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Hairy cell leukaemia  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Intraductal proliferative breast lesion  1  2/1306 (0.15%)  2 1/655 (0.15%)  1
Invasive ductal breast carcinoma  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Leiomyoma  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Ovarian adenoma  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Papillary thyroid cancer  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Prostate cancer  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Cerebral infarction  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Cranial nerve disorder  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Dizziness  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Headache  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Idiopathic intracranial hypertension  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Ischaemic stroke  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Nerve compression  1  1/1306 (0.08%)  1 1/655 (0.15%)  1
Peroneal nerve palsy  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Psychogenic seizure  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Vertigo CNS origin  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  2/1306 (0.15%)  2 0/655 (0.00%)  0
Ectopic pregnancy  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Psychiatric disorders     
Acute stress disorder  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Anxiety  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Suicidal ideation  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Suicide attempt  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Renal and urinary disorders     
Calculus urinary  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Nephrolithiasis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Reproductive system and breast disorders     
Dysfunctional uterine bleeding  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Erectile dysfunction  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Ovarian cyst  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Uterine haemorrhage  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Asthma  1  0/1306 (0.00%)  0 2/655 (0.31%)  2
Nasal polyps  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Pleurisy  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Pulmonary embolism  1  2/1306 (0.15%)  2 2/655 (0.31%)  2
Tonsillar hypertrophy  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Skin and subcutaneous tissue disorders     
Actinic keratosis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Decubitus ulcer  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Hidradenitis  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Surgical and medical procedures     
Abdominoplasty  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Bone prosthesis insertion  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Cholecystectomy  1  1/1306 (0.08%)  1 1/655 (0.15%)  1
Gastric bypass  1  1/1306 (0.08%)  1 1/655 (0.15%)  1
Hip surgery  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Intervertebral disc operation  1  1/1306 (0.08%)  1 0/655 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
Haematoma  1  0/1306 (0.00%)  0 1/655 (0.15%)  1
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%
Sema 2.4 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1052/1306 (80.55%)      447/655 (68.24%)    
Gastrointestinal disorders     
Abdominal distension  1  96/1306 (7.35%)  135 31/655 (4.73%)  42
Abdominal pain  1  127/1306 (9.72%)  172 36/655 (5.50%)  41
Abdominal pain upper  1  125/1306 (9.57%)  176 35/655 (5.34%)  37
Constipation  1  305/1306 (23.35%)  389 62/655 (9.47%)  73
Diarrhoea  1  411/1306 (31.47%)  765 104/655 (15.88%)  138
Dyspepsia  1  135/1306 (10.34%)  179 23/655 (3.51%)  30
Eructation  1  112/1306 (8.58%)  139 3/655 (0.46%)  3
Gastrooesophageal reflux disease  1  82/1306 (6.28%)  92 20/655 (3.05%)  21
Nausea  1  576/1306 (44.10%)  1067 114/655 (17.40%)  146
Vomiting  1  321/1306 (24.58%)  632 43/655 (6.56%)  52
General disorders     
Fatigue  1  104/1306 (7.96%)  120 28/655 (4.27%)  29
Infections and infestations     
Gastroenteritis  1  81/1306 (6.20%)  99 30/655 (4.58%)  38
Influenza  1  89/1306 (6.81%)  112 63/655 (9.62%)  79
Nasopharyngitis  1  281/1306 (21.52%)  480 133/655 (20.31%)  216
Sinusitis  1  70/1306 (5.36%)  83 36/655 (5.50%)  40
Upper respiratory tract infection  1  114/1306 (8.73%)  158 80/655 (12.21%)  116
Urinary tract infection  1  68/1306 (5.21%)  83 28/655 (4.27%)  33
Metabolism and nutrition disorders     
Decreased appetite  1  124/1306 (9.49%)  139 22/655 (3.36%)  26
Musculoskeletal and connective tissue disorders     
Arthralgia  1  81/1306 (6.20%)  92 43/655 (6.56%)  47
Back pain  1  106/1306 (8.12%)  120 53/655 (8.09%)  55
Nervous system disorders     
Dizziness  1  98/1306 (7.50%)  129 23/655 (3.51%)  35
Headache  1  198/1306 (15.16%)  386 80/655 (12.21%)  104
Respiratory, thoracic and mediastinal disorders     
Cough  1  40/1306 (3.06%)  45 33/655 (5.04%)  35
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 Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
EMail: clinicaltrials@novonordisk.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03548935    
Other Study ID Numbers: NN9536-4373
U1111-1200-8053 ( Other Identifier: World Health Organization (WHO) )
2017-003436-36 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Submitted: May 25, 2018
First Posted: June 7, 2018
Results First Submitted: June 16, 2021
Results First Posted: August 11, 2021
Last Update Posted: November 19, 2021