STEP 8: Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04074161
• Collaborator: (none)
• Enrollment: 338
• Locations: 19
• Arms: 4
• Actual Duration (Months): 20
• Patients Per Site: 17.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This study will look at participants' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Drug: Semaglutide; Drug: Placebo (semaglutide); Drug: Liraglutide; Drug: Placebo (liraglutide)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 338 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Semaglutide once weekly vs liraglutide once daily treatment will be open label, but each of the two active treatment arms will be double blinded against placebo administered at the same dosing frequency. Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Primary Purpose: Treatment
• Official Title: Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity
• Actual Study Start Date: Sep 11, 2019
• Actual Primary Completion Date: Mar 27, 2021
• Actual Study Completion Date: May 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity	Drug: Semaglutide; Dose gradually increased to 2.4 mg administered once weekly for 68 weeks
Placebo Comparator: Placebo (semaglutide) Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity	Drug: Placebo (semaglutide); Administered once weekly for 68 weeks
Active Comparator: Liraglutide Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity	Drug: Liraglutide; Dose gradually increased to 3.0 mg administered once daily for 68 weeks
Placebo Comparator: Placebo (liraglutide) Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity	Drug: Placebo (liraglutide); Administered once daily for 68 weeks

Outcome Measures

Primary Outcome Measures

1. Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg) [Baseline (week 0), week 68]

   Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

Secondary Outcome Measures

1. Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) [From baseline (week 0) to week 68]

   Number of participants who achieved >= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

2. Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) [From baseline (week 0) to week 68]

   Number of participants who achieved >= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 15% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

3. Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) [From baseline (week 0) to week 68]

   Number of participants who achieved >= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 20% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

4. Change From Baseline (Week 0) to Week 68 in Waist Circumference [Baseline (week 0), week 68]

   Change from baseline (week 0) to week 68 in waist circumference is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

5. Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg)) [Baseline (week 0), week 68]

   Change from baseline (week 0) to week 68 in body weight is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

6. Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo) [Baseline (week 0), week 68]

   Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

7. Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure [Baseline (week 0), week 68]

   Change from baseline (week 0) to week 68 in systolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

8. Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure [Baseline (week 0), week 68]

   Change from baseline (week 0) to week 68 in diastolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

9. Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline) [Baseline (week 0), week 68]

   Change from baseline (week 0) to week 68 in total cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

10. Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

11. Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

12. Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

13. Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

14. Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

15. Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

16. Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

17. Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in FFA (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

18. Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in FFA (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

19. Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in triglycerides (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

20. Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in triglycerides (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

21. Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in hs-CRP (measured in mg/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

22. Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in HbA1c (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

23. Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol)) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in HbA1c is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

24. Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

25. Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L) [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

26. Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in fasting serum insulin (measured in mIU/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

27. Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline [Baseline (week 0), week 68]

    Change from baseline (week 0) to week 68 in fasting serum insulin (measured in pmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

28. Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) [Baseline (week 0), week 68]

    Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and 68 are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: fasting plasma glucose (FPG) less than (<) 5.6 mmol/L (<100 mg/dL) and/or glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: FPG 5.6 - 6.9 mmol/L (both inclusive), FPG 100 - 125 mg/dL (both inclusive) or HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: FPG greater than or equal to (>=) 7.0 mmol/L (>=126 mg/dL) and/or HbA1c >=6.5%. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

29. Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product [From baseline (week 0) to week 68]

    Number of participants who from baseline (week 0) to week 68 permanently discontinued randomized trial product are presented.

30. Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75 [From baseline (week 0) to week 75]

    An adverse event (AE) was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs mentioned here are TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.

31. Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75 [From baseline (week 0) to week 75]

    An AE was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as an AE that 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 is a congenital anomaly/birth defect. SAEs occurred based on the on-treatment period is presented. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, age 18 years or older at the time of signing informed consent

• Body mass index (BMI) equal to or above 30.0 kg/m^{2 or equal to or above 27.0 kg/m}2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

• History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

• HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening

• History of type 1 or type 2 diabetes mellitus

• A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35294
2	Novo Nordisk Investigational Site	Fullerton	California	United States	92835
3	Novo Nordisk Investigational Site	Huntington Beach	California	United States	92648
4	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32205
5	Novo Nordisk Investigational Site	Plantation	Florida	United States	33324
6	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
7	Novo Nordisk Investigational Site	Evanston	Illinois	United States	60201-2477
8	Novo Nordisk Investigational Site	Indianapolis	Indiana	United States	46260
9	Novo Nordisk Investigational Site	Baton Rouge	Louisiana	United States	70808
10	Novo Nordisk Investigational Site	Albany	New York	United States	12203
11	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
12	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104-3317
13	Novo Nordisk Investigational Site	Charleston	South Carolina	United States	29425
14	Novo Nordisk Investigational Site	Dallas	Texas	United States	75226
15	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
16	Novo Nordisk Investigational Site	Rockwall	Texas	United States	75032
17	Novo Nordisk Investigational Site	Arlington	Virginia	United States	22206
18	Novo Nordisk Investigational Site	Winchester	Virginia	United States	22601-3834
19	Novo Nordisk Investigational Site	Olympia	Washington	United States	98502

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

• Study Protocol - Nov 25, 2020
• Statistical Analysis Plan - Jul 8, 2021

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04074161
• Other Study ID Numbers: NN9536-4576; U1111-1233-0977
• First Posted: Aug 29, 2019
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Overweight; Liraglutide

Study Results

Participant Flow

Recruitment Details

The trial was conducted at 19 sites in the United States (US).

Pre-assignment Detail

Total 338 adults with obesity (BMI greater than or equal to (>=30.0) kilograms per square meter (kg/m^2)) or overweight (BMI >= 27.0 kg/m^2) and at least one weight-related comorbidity were randomized in a 3:1:3:1 manner to receive treatment with either semaglutide subcutaneously (s.c.) 2.4 milligram (mg) once weekly or semaglutide placebo once weekly or liraglutide s.c. 3.0 mg once daily or liraglutide placebo once daily as an adjunct to a reduced-calorie diet and increased physical activity.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Period Title: Overall Study
STARTED	126	127	85
Full Analysis Set	126	127	85
Safety Analysis Set	126	127	85
COMPLETED	120	118	81
NOT COMPLETED	6	9	4

Baseline Characteristics

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo	Total
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Total of all reporting groups
Overall Participants	126	127	85	338
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	48 (14)	49 (13)	51 (12)	49 (13)
Sex: Female, Male (Count of Participants)
Female	102 81%	97 76.4%	66 77.6%	265 78.4%
Male	24 19%	30 23.6%	19 22.4%	73 21.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 11.9%	17 13.4%	7 8.2%	39 11.5%
Not Hispanic or Latino	111 88.1%	110 86.6%	78 91.8%	299 88.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	94 74.6%	95 74.8%	60 70.6%	249 73.7%
Black or African American	25 19.8%	20 15.7%	19 22.4%	64 18.9%
Asian	4 3.2%	6 4.7%	3 3.5%	13 3.8%
Other	2 1.6%	3 2.4%	2 2.4%	7 2.1%
Native Hawaiian or Other Pacific Islander	1 0.8%	3 2.4%	1 1.2%	5 1.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)
Description	Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

The full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. It was planned to report data only for arms 'semaglutide 2.4 mg and liraglutide 3.0 mg' for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	117	117
Mean (Standard Deviation) [Percentage of body weight]	-16.4 (10.5)	-6.4 (7.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Semaglutide 2.4 mg, Liraglutide 3.0 mg
	Comments
	Type of Statistical Test	Superiority
	Comments	Responses were analysed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-9.38
	Confidence Interval	(2-Sided) 95%; -11.97 to -6.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)
Description	Number of participants who achieved >= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	From baseline (week 0) to week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	117	117	78
Yes	83 65.9%	30 23.6%	12 14.1%
No	34 27%	87 68.5%	66 77.6%

3. Secondary Outcome

Title	Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)
Description	Number of participants who achieved >= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 15% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	From baseline (week 0) to week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	117	117	78
Yes	65 51.6%	14 11%	5 5.9%
No	52 41.3%	103 81.1%	73 85.9%

4. Secondary Outcome

Title	Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)
Description	Number of participants who achieved >= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 20% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	From baseline (week 0) to week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	117	117	78
Yes	45 35.7%	7 5.5%	2 2.4%
No	72 57.1%	110 86.6%	76 89.4%

5. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Waist Circumference
Description	Change from baseline (week 0) to week 68 in waist circumference is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	114	113	76
Mean (Standard Deviation) [centimeters (cm)]	-13.6 (10.0)	-6.8 (8.4)	-2.0 (7.2)

6. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))
Description	Change from baseline (week 0) to week 68 in body weight is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	117	117	78
Mean (Standard Deviation) [kilograms]	-15.8 (10.2)	-6.8 (9.5)	-1.4 (9.6)

7. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)
Description	Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

The full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	117	117	78
Mean (Standard Deviation) [Percentage of body weight]	-16.4 (10.5)	-6.4 (7.7)	-1.6 (8.6)

8. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure
Description	Change from baseline (week 0) to week 68 in systolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	114	112	77
Mean (Standard Deviation) [millimeters of mercury (mmHg)]	-7 (14)	-4 (15)	5 (14)

9. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure
Description	Change from baseline (week 0) to week 68 in diastolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	114	112	77
Mean (Standard Deviation) [mmHg]	-5 (9)	-1 (11)	1 (9)

10. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in total cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	112	106	74
Geometric Mean (Geometric Coefficient of Variation) [Ratio of total cholesterol]	0.92 (12.9)	1.00 (15.0)	0.99 (17.6)

11. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	112	106	76
Geometric Mean (Geometric Coefficient of Variation) [Ratio of total cholesterol]	0.92 (12.9)	1.00 (15.0)	0.99 (17.6)

12. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	106	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of HDL cholesterol]	0.99 (14.7)	1.02 (14.4)	0.99 (15.4)

13. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	106	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of HDL cholesterol]	0.99 (14.7)	1.02 (14.4)	0.99 (15.4)

14. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	106	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of LDL cholesterol]	0.93 (19.7)	1.01 (23.4)	0.99 (26.3)

15. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	106	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of LDL cholesterol]	0.93 (19.7)	1.01 (23.4)	0.99 (26.3)

16. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	106	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of VLDL cholesterol]	0.79 (33.1)	0.89 (36.9)	0.97 (34.7)

17. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	106	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of VLDL cholesterol]	0.79 (33.1)	0.89 (36.9)	0.97 (34.7)

18. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in FFA (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	107	107	72
Geometric Mean (Geometric Coefficient of Variation) [Ratio of FFA]	0.90 (81.5)	0.87 (77.7)	1.10 (77.2)

19. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in FFA (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	107	107	72
Geometric Mean (Geometric Coefficient of Variation) [Ratio of FFA]	0.90 (81.5)	0.87 (77.7)	1.10 (77.2)

20. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in triglycerides (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	106	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of triglycerides]	0.80 (33.0)	0.89 (36.7)	0.98 (35.7)

21. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)
Description	Change from baseline (week 0) to week 68 in triglycerides (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	106	73
Geometric Mean (Geometric Coefficient of Variation) [Ratio of triglycerides]	0.80 (33.0)	0.89 (36.7)	0.98 (35.7)

22. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline
Description	Change from baseline (week 0) to week 68 in hs-CRP (measured in mg/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	112	109	74
Geometric Mean (Geometric Coefficient of Variation) [Ratio of hs-CRP]	0.46 (154.1)	0.73 (93.0)	0.78 (71.5)

23. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)
Description	Change from baseline (week 0) to week 68 in HbA1c (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	113	107	76
Mean (Standard Deviation) [Percenatge of HbA1c]	-0.3 (0.2)	-0.1 (0.3)	0.1 (0.2)

24. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))
Description	Change from baseline (week 0) to week 68 in HbA1c is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	113	107	76
Mean (Standard Deviation) [mmol/mol]	-2.8 (2.6)	-1.0 (2.7)	1.2 (2.5)

25. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)
Description	Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	105	73
Mean (Standard Deviation) [mg/dL]	-9.0 (9.6)	-4.9 (10.4)	2.4 (10.9)

26. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)
Description	Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	111	105	73
Mean (Standard Deviation) [mmol/L]	-0.5 (0.5)	-0.3 (0.6)	0.1 (0.6)

27. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline
Description	Change from baseline (week 0) to week 68 in fasting serum insulin (measured in mIU/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	107	107	71
Geometric Mean (Geometric Coefficient of Variation) [Ratio of fasting serum insulin]	0.73 (57.3)	0.85 (47.5)	0.98 (56.8)

28. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline
Description	Change from baseline (week 0) to week 68 in fasting serum insulin (measured in pmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	107	107	71
Geometric Mean (Geometric Coefficient of Variation) [Ratio of fasting serum insulin]	0.73 (57.3)	0.85 (47.5)	0.98 (56.8)

29. Secondary Outcome

Title	Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))
Description	Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and 68 are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: fasting plasma glucose (FPG) less than (<) 5.6 mmol/L (<100 mg/dL) and/or glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: FPG 5.6 - 6.9 mmol/L (both inclusive), FPG 100 - 125 mg/dL (both inclusive) or HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: FPG greater than or equal to (>=) 7.0 mmol/L (>=126 mg/dL) and/or HbA1c >=6.5%. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time Frame	Baseline (week 0), week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	110	111	77
Baseline (week 0): normo-glycaemia	72 57.1%	74 58.3%	47 55.3%
Baseline (week 0): pre-diabetes	38 30.2%	37 29.1%	30 35.3%
Baseline (week 0): type 2 diabetes	0 0%	0 0%	0 0%
Week 68: normo-glycaemia	104 82.5%	89 70.1%	38 44.7%
Week 68: pre-diabetes	5 4%	21 16.5%	36 42.4%
Week 68: type 2 diabetes	1 0.8%	1 0.8%	3 3.5%

30. Secondary Outcome

Title	Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product
Description	Number of participants who from baseline (week 0) to week 68 permanently discontinued randomized trial product are presented.
Time Frame	From baseline (week 0) to week 68

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	126	127	85
Count of Participants [Participants]	17 13.5%	35 27.6%	15 17.6%

31. Secondary Outcome

Title	Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75
Description	An adverse event (AE) was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs mentioned here are TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.
Time Frame	From baseline (week 0) to week 75

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAS) included all randomized participants exposed to at least one dose of randomized treatment.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	126	127	85
Number [Events]	904	823	522

32. Secondary Outcome

Title	Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75
Description	An AE was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as an AE that 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 is a congenital anomaly/birth defect. SAEs occurred based on the on-treatment period is presented. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.
Time Frame	From baseline (week 0) to week 75

Outcome Measure Data

Analysis Population Description

SAS included all randomized participants exposed to at least one dose of randomized treatment.

Arm/Group Title	Semaglutide 2.4 mg	Liraglutide 3.0 mg	Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
Measure Participants	126	127	85
Number [Events]	14	18	9

Adverse Events

Time Frame	From week 0 to week 75
Adverse Event Reporting Description	All presented AEs are treatment-emergent (i.e., TEAEs). TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. Results are based on the SAS which included all randomized participants exposed to at least one dose of randomized treatment.
Arm/Group Title	Semaglutide 2.4 mg		Liraglutide 3.0 mg		Pooled Placebo
Arm/Group Description	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.		The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.		Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
All Cause Mortality
	Semaglutide 2.4 mg		Liraglutide 3.0 mg		Pooled Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		0/127 (0%)		0/85 (0%)
Serious Adverse Events
	Semaglutide 2.4 mg		Liraglutide 3.0 mg		Pooled Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/126 (7.9%)		14/127 (11%)		6/85 (7.1%)
Cardiac disorders
Atrial flutter	0/126 (0%)	0	0/127 (0%)	0	1/85 (1.2%)	1
Bradyarrhythmia	0/126 (0%)	0	0/127 (0%)	0	1/85 (1.2%)	1
Cardiac failure congestive	0/126 (0%)	0	0/127 (0%)	0	1/85 (1.2%)	1
Coronary artery occlusion	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Sinus node dysfunction	0/126 (0%)	0	0/127 (0%)	0	1/85 (1.2%)	1
Ear and labyrinth disorders
Vertigo	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
General disorders
Chest discomfort	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Non-cardiac chest pain	0/126 (0%)	0	0/127 (0%)	0	1/85 (1.2%)	1
Hepatobiliary disorders
Cholecystitis acute	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Cholelithiasis	1/126 (0.8%)	1	1/127 (0.8%)	1	1/85 (1.2%)	1
Immune system disorders
Anaphylactic reaction	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Infections and infestations
COVID-19 pneumonia	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Cholecystitis infective	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Influenza	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Osteomyelitis	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Sepsis	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Streptococcal sepsis	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Viral sepsis	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Metabolism and nutrition disorders
Lactose intolerance	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Musculoskeletal and connective tissue disorders
Foot deformity	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Osteoarthritis	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Osteonecrosis	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Clear cell renal cell carcinoma	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Invasive ductal breast carcinoma	1/126 (0.8%)	1	1/127 (0.8%)	1	1/85 (1.2%)	1
Invasive lobular breast carcinoma	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Nervous system disorders
Lumbar radiculopathy	0/126 (0%)	0	0/127 (0%)	0	1/85 (1.2%)	1
Transient ischaemic attack	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Psychiatric disorders
Major depression	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Renal and urinary disorders
Acute kidney injury	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Reproductive system and breast disorders
Uterine enlargement	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Asthma	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Pulmonary embolism	0/126 (0%)	0	0/127 (0%)	0	1/85 (1.2%)	1
Surgical and medical procedures
Cardiac ablation	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Post procedural drainage	0/126 (0%)	0	1/127 (0.8%)	1	0/85 (0%)	0
Vascular disorders
Aortic stenosis	1/126 (0.8%)	1	0/127 (0%)	0	0/85 (0%)	0
Other (Not Including Serious) Adverse Events
	Semaglutide 2.4 mg		Liraglutide 3.0 mg		Pooled Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	115/126 (91.3%)		115/127 (90.6%)		68/85 (80%)
Gastrointestinal disorders
Abdominal distension	7/126 (5.6%)	9	9/127 (7.1%)	10	7/85 (8.2%)	8
Abdominal pain	8/126 (6.3%)	8	5/127 (3.9%)	5	1/85 (1.2%)	1
Constipation	49/126 (38.9%)	80	40/127 (31.5%)	52	20/85 (23.5%)	24
Diarrhoea	35/126 (27.8%)	51	23/127 (18.1%)	37	22/85 (25.9%)	26
Dry mouth	7/126 (5.6%)	7	6/127 (4.7%)	7	5/85 (5.9%)	6
Dyspepsia	11/126 (8.7%)	14	15/127 (11.8%)	16	5/85 (5.9%)	7
Eructation	17/126 (13.5%)	20	5/127 (3.9%)	5	4/85 (4.7%)	4
Flatulence	10/126 (7.9%)	13	4/127 (3.1%)	4	6/85 (7.1%)	6
Gastrooesophageal reflux disease	12/126 (9.5%)	14	11/127 (8.7%)	13	5/85 (5.9%)	5
Nausea	77/126 (61.1%)	130	75/127 (59.1%)	102	19/85 (22.4%)	24
Vomiting	32/126 (25.4%)	50	26/127 (20.5%)	34	5/85 (5.9%)	6
General disorders
Fatigue	12/126 (9.5%)	12	14/127 (11%)	17	4/85 (4.7%)	4
Immune system disorders
Seasonal allergy	1/126 (0.8%)	1	5/127 (3.9%)	10	5/85 (5.9%)	6
Infections and infestations
Bronchitis	5/126 (4%)	6	5/127 (3.9%)	6	5/85 (5.9%)	5
COVID-19	5/126 (4%)	5	11/127 (8.7%)	11	5/85 (5.9%)	6
Influenza	4/126 (3.2%)	4	14/127 (11%)	14	6/85 (7.1%)	6
Nasopharyngitis	10/126 (7.9%)	10	11/127 (8.7%)	13	9/85 (10.6%)	11
Sinusitis	8/126 (6.3%)	9	8/127 (6.3%)	8	13/85 (15.3%)	14
Upper respiratory tract infection	9/126 (7.1%)	11	19/127 (15%)	26	18/85 (21.2%)	23
Urinary tract infection	7/126 (5.6%)	10	5/127 (3.9%)	5	2/85 (2.4%)	2
Metabolism and nutrition disorders
Decreased appetite	15/126 (11.9%)	15	16/127 (12.6%)	18	3/85 (3.5%)	3
Musculoskeletal and connective tissue disorders
Arthralgia	8/126 (6.3%)	8	14/127 (11%)	15	7/85 (8.2%)	7
Back pain	6/126 (4.8%)	6	9/127 (7.1%)	10	9/85 (10.6%)	10
Nervous system disorders
Dizziness	10/126 (7.9%)	11	7/127 (5.5%)	8	4/85 (4.7%)	4
Headache	20/126 (15.9%)	46	18/127 (14.2%)	20	10/85 (11.8%)	12
Psychiatric disorders
Insomnia	3/126 (2.4%)	3	7/127 (5.5%)	7	2/85 (2.4%)	2
Respiratory, thoracic and mediastinal disorders
Cough	7/126 (5.6%)	8	4/127 (3.1%)	5	5/85 (5.9%)	5
Skin and subcutaneous tissue disorders
Rash	3/126 (2.4%)	3	2/127 (1.6%)	2	5/85 (5.9%)	6
Vascular disorders
Hypertension	8/126 (6.3%)	8	3/127 (2.4%)	3	2/85 (2.4%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.