Trial Outcomes & Findings for Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity (NCT NCT04074161)

NCT ID: NCT04074161

Last Updated: 2023-05-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 338 participants
• Primary outcome timeframe: Baseline (week 0), week 68
• Results posted on: 2023-05-19

Participant Flow

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

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.

Participant milestones

Measure	Semaglutide 2.4 mg 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.	Liraglutide 3.0 mg 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.	Pooled Placebo 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.
Overall Study STARTED	126	127	85
Overall Study Full Analysis Set	126	127	85
Overall Study Safety Analysis Set	126	127	85
Overall Study COMPLETED	120	118	81
Overall Study NOT COMPLETED	6	9	4

Reasons for withdrawal

Measure	Semaglutide 2.4 mg 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.	Liraglutide 3.0 mg 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.	Pooled Placebo 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.
Overall Study Withdrawal by Subject	2	4	1
Overall Study Lost to Follow-up	4	5	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Semaglutide 2.4 mg n=126 Participants 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.	Liraglutide 3.0 mg n=127 Participants 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.	Pooled Placebo n=85 Participants 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 n=338 Participants Total of all reporting groups
Age, Continuous	48 Years STANDARD_DEVIATION 14 • n=5 Participants	49 Years STANDARD_DEVIATION 13 • n=7 Participants	51 Years STANDARD_DEVIATION 12 • n=5 Participants	49 Years STANDARD_DEVIATION 13 • n=4 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	97 Participants n=7 Participants	66 Participants n=5 Participants	265 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	30 Participants n=7 Participants	19 Participants n=5 Participants	73 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	17 Participants n=7 Participants	7 Participants n=5 Participants	39 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants	110 Participants n=7 Participants	78 Participants n=5 Participants	299 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	94 Participants n=5 Participants	95 Participants n=7 Participants	60 Participants n=5 Participants	249 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	25 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	64 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), week 68

Population: 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.

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=117 Participants 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.	Liraglutide 3.0 mg n=117 Participants 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.	Pooled Placebo 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.
Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)	-16.4 Percentage of body weight Standard Deviation 10.5	-6.4 Percentage of body weight Standard Deviation 7.7	—

SECONDARY outcome

Timeframe: From baseline (week 0) to week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=117 Participants 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.	Liraglutide 3.0 mg n=117 Participants 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.	Pooled Placebo n=78 Participants 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.
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) No	34 Participants	87 Participants	66 Participants
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) Yes	83 Participants	30 Participants	12 Participants

SECONDARY outcome

Timeframe: From baseline (week 0) to week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=117 Participants 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.	Liraglutide 3.0 mg n=117 Participants 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.	Pooled Placebo n=78 Participants 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.
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) Yes	65 Participants	14 Participants	5 Participants
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) No	52 Participants	103 Participants	73 Participants

SECONDARY outcome

Timeframe: From baseline (week 0) to week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=117 Participants 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.	Liraglutide 3.0 mg n=117 Participants 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.	Pooled Placebo n=78 Participants 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.
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) Yes	45 Participants	7 Participants	2 Participants
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) No	72 Participants	110 Participants	76 Participants

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=114 Participants 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.	Liraglutide 3.0 mg n=113 Participants 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.	Pooled Placebo n=76 Participants 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.
Change From Baseline (Week 0) to Week 68 in Waist Circumference	-13.6 centimeters (cm) Standard Deviation 10.0	-6.8 centimeters (cm) Standard Deviation 8.4	-2.0 centimeters (cm) Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=117 Participants 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.	Liraglutide 3.0 mg n=117 Participants 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.	Pooled Placebo n=78 Participants 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.
Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))	-15.8 kilograms Standard Deviation 10.2	-6.8 kilograms Standard Deviation 9.5	-1.4 kilograms Standard Deviation 9.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=117 Participants 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.	Liraglutide 3.0 mg n=117 Participants 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.	Pooled Placebo n=78 Participants 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.
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)	-16.4 Percentage of body weight Standard Deviation 10.5	-6.4 Percentage of body weight Standard Deviation 7.7	-1.6 Percentage of body weight Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=114 Participants 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.	Liraglutide 3.0 mg n=112 Participants 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.	Pooled Placebo n=77 Participants 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.
Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure	-7 millimeters of mercury (mmHg) Standard Deviation 14	-4 millimeters of mercury (mmHg) Standard Deviation 15	5 millimeters of mercury (mmHg) Standard Deviation 14

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=114 Participants 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.	Liraglutide 3.0 mg n=112 Participants 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.	Pooled Placebo n=77 Participants 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.
Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure	-5 mmHg Standard Deviation 9	-1 mmHg Standard Deviation 11	1 mmHg Standard Deviation 9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=112 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=74 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)	0.92 Ratio of total cholesterol Geometric Coefficient of Variation 12.9	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 15.0	0.99 Ratio of total cholesterol Geometric Coefficient of Variation 17.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=112 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=76 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)	0.92 Ratio of total cholesterol Geometric Coefficient of Variation 12.9	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 15.0	0.99 Ratio of total cholesterol Geometric Coefficient of Variation 17.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.7	1.02 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.4	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.4

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.7	1.02 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.4	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.4

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)	0.93 Ratio of LDL cholesterol Geometric Coefficient of Variation 19.7	1.01 Ratio of LDL cholesterol Geometric Coefficient of Variation 23.4	0.99 Ratio of LDL cholesterol Geometric Coefficient of Variation 26.3

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)	0.93 Ratio of LDL cholesterol Geometric Coefficient of Variation 19.7	1.01 Ratio of LDL cholesterol Geometric Coefficient of Variation 23.4	0.99 Ratio of LDL cholesterol Geometric Coefficient of Variation 26.3

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)	0.79 Ratio of VLDL cholesterol Geometric Coefficient of Variation 33.1	0.89 Ratio of VLDL cholesterol Geometric Coefficient of Variation 36.9	0.97 Ratio of VLDL cholesterol Geometric Coefficient of Variation 34.7

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)	0.79 Ratio of VLDL cholesterol Geometric Coefficient of Variation 33.1	0.89 Ratio of VLDL cholesterol Geometric Coefficient of Variation 36.9	0.97 Ratio of VLDL cholesterol Geometric Coefficient of Variation 34.7

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=107 Participants 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.	Liraglutide 3.0 mg n=107 Participants 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.	Pooled Placebo n=72 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)	0.90 Ratio of FFA Geometric Coefficient of Variation 81.5	0.87 Ratio of FFA Geometric Coefficient of Variation 77.7	1.10 Ratio of FFA Geometric Coefficient of Variation 77.2

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=107 Participants 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.	Liraglutide 3.0 mg n=107 Participants 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.	Pooled Placebo n=72 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)	0.90 Ratio of FFA Geometric Coefficient of Variation 81.5	0.87 Ratio of FFA Geometric Coefficient of Variation 77.7	1.10 Ratio of FFA Geometric Coefficient of Variation 77.2

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)	0.80 Ratio of triglycerides Geometric Coefficient of Variation 33.0	0.89 Ratio of triglycerides Geometric Coefficient of Variation 36.7	0.98 Ratio of triglycerides Geometric Coefficient of Variation 35.7

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=106 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)	0.80 Ratio of triglycerides Geometric Coefficient of Variation 33.0	0.89 Ratio of triglycerides Geometric Coefficient of Variation 36.7	0.98 Ratio of triglycerides Geometric Coefficient of Variation 35.7

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=112 Participants 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.	Liraglutide 3.0 mg n=109 Participants 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.	Pooled Placebo n=74 Participants 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.
Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline	0.46 Ratio of hs-CRP Geometric Coefficient of Variation 154.1	0.73 Ratio of hs-CRP Geometric Coefficient of Variation 93.0	0.78 Ratio of hs-CRP Geometric Coefficient of Variation 71.5

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=113 Participants 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.	Liraglutide 3.0 mg n=107 Participants 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.	Pooled Placebo n=76 Participants 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.
Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)	-0.3 Percenatge of HbA1c Standard Deviation 0.2	-0.1 Percenatge of HbA1c Standard Deviation 0.3	0.1 Percenatge of HbA1c Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=113 Participants 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.	Liraglutide 3.0 mg n=107 Participants 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.	Pooled Placebo n=76 Participants 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.
Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))	-2.8 mmol/mol Standard Deviation 2.6	-1.0 mmol/mol Standard Deviation 2.7	1.2 mmol/mol Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=105 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)	-9.0 mg/dL Standard Deviation 9.6	-4.9 mg/dL Standard Deviation 10.4	2.4 mg/dL Standard Deviation 10.9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=111 Participants 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.	Liraglutide 3.0 mg n=105 Participants 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.	Pooled Placebo n=73 Participants 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.
Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)	-0.5 mmol/L Standard Deviation 0.5	-0.3 mmol/L Standard Deviation 0.6	0.1 mmol/L Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=107 Participants 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.	Liraglutide 3.0 mg n=107 Participants 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.	Pooled Placebo n=71 Participants 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.
Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline	0.73 Ratio of fasting serum insulin Geometric Coefficient of Variation 57.3	0.85 Ratio of fasting serum insulin Geometric Coefficient of Variation 47.5	0.98 Ratio of fasting serum insulin Geometric Coefficient of Variation 56.8

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=107 Participants 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.	Liraglutide 3.0 mg n=107 Participants 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.	Pooled Placebo n=71 Participants 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.
Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline	0.73 Ratio of fasting serum insulin Geometric Coefficient of Variation 57.3	0.85 Ratio of fasting serum insulin Geometric Coefficient of Variation 47.5	0.98 Ratio of fasting serum insulin Geometric Coefficient of Variation 56.8

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=110 Participants 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.	Liraglutide 3.0 mg n=111 Participants 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.	Pooled Placebo n=77 Participants 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.
Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) Baseline (week 0): normo-glycaemia	72 Participants	74 Participants	47 Participants
Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) Baseline (week 0): pre-diabetes	38 Participants	37 Participants	30 Participants
Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) Baseline (week 0): type 2 diabetes	0 Participants	0 Participants	0 Participants
Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) Week 68: normo-glycaemia	104 Participants	89 Participants	38 Participants
Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) Week 68: pre-diabetes	5 Participants	21 Participants	36 Participants
Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) Week 68: type 2 diabetes	1 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: From baseline (week 0) to week 68

Population: FAS included all randomized participants.

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

Outcome measures

Measure	Semaglutide 2.4 mg n=126 Participants 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.	Liraglutide 3.0 mg n=127 Participants 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.	Pooled Placebo n=85 Participants 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.
Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product	17 Participants	35 Participants	15 Participants

SECONDARY outcome

Timeframe: From baseline (week 0) to week 75

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=126 Participants 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.	Liraglutide 3.0 mg n=127 Participants 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.	Pooled Placebo n=85 Participants 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.
Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75	904 Events	823 Events	522 Events

SECONDARY outcome

Timeframe: From baseline (week 0) to week 75

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

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.

Outcome measures

Measure	Semaglutide 2.4 mg n=126 Participants 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.	Liraglutide 3.0 mg n=127 Participants 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.	Pooled Placebo n=85 Participants 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.
Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75	14 Events	18 Events	9 Events

Adverse Events

Semaglutide 2.4 mg

Serious events: 10 serious events

Other events: 115 other events

Deaths: 0 deaths

Liraglutide 3.0 mg

Serious events: 14 serious events

Other events: 115 other events

Deaths: 0 deaths

Pooled Placebo

Serious events: 6 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Measure	Semaglutide 2.4 mg n=126 participants at risk 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.	Liraglutide 3.0 mg n=127 participants at risk 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.	Pooled Placebo n=85 participants at risk 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.
Surgical and medical procedures Cardiac ablation	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Renal and urinary disorders Acute kidney injury	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Immune system disorders Anaphylactic reaction	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Vascular disorders Aortic stenosis	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Cardiac disorders Atrial flutter	0.00% 0/126 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Cardiac disorders Bradyarrhythmia	0.00% 0/126 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Infections and infestations COVID-19 pneumonia	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Cardiac disorders Cardiac failure congestive	0.00% 0/126 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
General disorders Chest discomfort	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Infections and infestations Cholecystitis infective	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Hepatobiliary disorders Cholelithiasis	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Cardiac disorders Coronary artery occlusion	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Infections and infestations Influenza	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Nervous system disorders Lumbar radiculopathy	0.00% 0/126 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Psychiatric disorders Major depression	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
General disorders Non-cardiac chest pain	0.00% 0/126 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Infections and infestations Osteomyelitis	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Surgical and medical procedures Post procedural drainage	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/126 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Infections and infestations Sepsis	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Cardiac disorders Sinus node dysfunction	0.00% 0/126 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Infections and infestations Streptococcal sepsis	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Nervous system disorders Transient ischaemic attack	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Reproductive system and breast disorders Uterine enlargement	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Ear and labyrinth disorders Vertigo	0.00% 0/126 • From week 0 to week 75 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.	0.79% 1/127 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.
Infections and infestations Viral sepsis	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	0.00% 0/127 • From week 0 to week 75 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.	0.00% 0/85 • From week 0 to week 75 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.

Other adverse events

Measure	Semaglutide 2.4 mg n=126 participants at risk 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.	Liraglutide 3.0 mg n=127 participants at risk 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.	Pooled Placebo n=85 participants at risk 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.
Gastrointestinal disorders Abdominal distension	5.6% 7/126 • Number of events 9 • From week 0 to week 75 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.	7.1% 9/127 • Number of events 10 • From week 0 to week 75 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.	8.2% 7/85 • Number of events 8 • From week 0 to week 75 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.
Gastrointestinal disorders Abdominal pain	6.3% 8/126 • Number of events 8 • From week 0 to week 75 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.	3.9% 5/127 • Number of events 5 • From week 0 to week 75 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.	1.2% 1/85 • Number of events 1 • From week 0 to week 75 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.
Musculoskeletal and connective tissue disorders Arthralgia	6.3% 8/126 • Number of events 8 • From week 0 to week 75 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.	11.0% 14/127 • Number of events 15 • From week 0 to week 75 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.	8.2% 7/85 • Number of events 7 • From week 0 to week 75 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.
Musculoskeletal and connective tissue disorders Back pain	4.8% 6/126 • Number of events 6 • From week 0 to week 75 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.	7.1% 9/127 • Number of events 10 • From week 0 to week 75 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.	10.6% 9/85 • Number of events 10 • From week 0 to week 75 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.
Infections and infestations Bronchitis	4.0% 5/126 • Number of events 6 • From week 0 to week 75 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.	3.9% 5/127 • Number of events 6 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 5 • From week 0 to week 75 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.
Infections and infestations COVID-19	4.0% 5/126 • Number of events 5 • From week 0 to week 75 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.	8.7% 11/127 • Number of events 11 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 6 • From week 0 to week 75 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.
Gastrointestinal disorders Constipation	38.9% 49/126 • Number of events 80 • From week 0 to week 75 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.	31.5% 40/127 • Number of events 52 • From week 0 to week 75 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.	23.5% 20/85 • Number of events 24 • From week 0 to week 75 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.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 7/126 • Number of events 8 • From week 0 to week 75 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.	3.1% 4/127 • Number of events 5 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 5 • From week 0 to week 75 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.
Metabolism and nutrition disorders Decreased appetite	11.9% 15/126 • Number of events 15 • From week 0 to week 75 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.	12.6% 16/127 • Number of events 18 • From week 0 to week 75 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.	3.5% 3/85 • Number of events 3 • From week 0 to week 75 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.
Gastrointestinal disorders Diarrhoea	27.8% 35/126 • Number of events 51 • From week 0 to week 75 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.	18.1% 23/127 • Number of events 37 • From week 0 to week 75 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.	25.9% 22/85 • Number of events 26 • From week 0 to week 75 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.
Nervous system disorders Dizziness	7.9% 10/126 • Number of events 11 • From week 0 to week 75 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.	5.5% 7/127 • Number of events 8 • From week 0 to week 75 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.	4.7% 4/85 • Number of events 4 • From week 0 to week 75 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.
Gastrointestinal disorders Dry mouth	5.6% 7/126 • Number of events 7 • From week 0 to week 75 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.	4.7% 6/127 • Number of events 7 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 6 • From week 0 to week 75 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.
Gastrointestinal disorders Dyspepsia	8.7% 11/126 • Number of events 14 • From week 0 to week 75 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.	11.8% 15/127 • Number of events 16 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 7 • From week 0 to week 75 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.
Gastrointestinal disorders Eructation	13.5% 17/126 • Number of events 20 • From week 0 to week 75 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.	3.9% 5/127 • Number of events 5 • From week 0 to week 75 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.	4.7% 4/85 • Number of events 4 • From week 0 to week 75 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.
General disorders Fatigue	9.5% 12/126 • Number of events 12 • From week 0 to week 75 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.	11.0% 14/127 • Number of events 17 • From week 0 to week 75 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.	4.7% 4/85 • Number of events 4 • From week 0 to week 75 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.
Gastrointestinal disorders Flatulence	7.9% 10/126 • Number of events 13 • From week 0 to week 75 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.	3.1% 4/127 • Number of events 4 • From week 0 to week 75 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.	7.1% 6/85 • Number of events 6 • From week 0 to week 75 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.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.5% 12/126 • Number of events 14 • From week 0 to week 75 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.	8.7% 11/127 • Number of events 13 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 5 • From week 0 to week 75 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.
Nervous system disorders Headache	15.9% 20/126 • Number of events 46 • From week 0 to week 75 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.	14.2% 18/127 • Number of events 20 • From week 0 to week 75 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.	11.8% 10/85 • Number of events 12 • From week 0 to week 75 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.
Vascular disorders Hypertension	6.3% 8/126 • Number of events 8 • From week 0 to week 75 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.	2.4% 3/127 • Number of events 3 • From week 0 to week 75 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.	2.4% 2/85 • Number of events 2 • From week 0 to week 75 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.
Infections and infestations Influenza	3.2% 4/126 • Number of events 4 • From week 0 to week 75 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.	11.0% 14/127 • Number of events 14 • From week 0 to week 75 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.	7.1% 6/85 • Number of events 6 • From week 0 to week 75 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.
Psychiatric disorders Insomnia	2.4% 3/126 • Number of events 3 • From week 0 to week 75 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.	5.5% 7/127 • Number of events 7 • From week 0 to week 75 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.	2.4% 2/85 • Number of events 2 • From week 0 to week 75 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.
Infections and infestations Nasopharyngitis	7.9% 10/126 • Number of events 10 • From week 0 to week 75 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.	8.7% 11/127 • Number of events 13 • From week 0 to week 75 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.	10.6% 9/85 • Number of events 11 • From week 0 to week 75 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.
Gastrointestinal disorders Nausea	61.1% 77/126 • Number of events 130 • From week 0 to week 75 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.	59.1% 75/127 • Number of events 102 • From week 0 to week 75 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.	22.4% 19/85 • Number of events 24 • From week 0 to week 75 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.
Skin and subcutaneous tissue disorders Rash	2.4% 3/126 • Number of events 3 • From week 0 to week 75 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.	1.6% 2/127 • Number of events 2 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 6 • From week 0 to week 75 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.
Immune system disorders Seasonal allergy	0.79% 1/126 • Number of events 1 • From week 0 to week 75 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.	3.9% 5/127 • Number of events 10 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 6 • From week 0 to week 75 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.
Infections and infestations Sinusitis	6.3% 8/126 • Number of events 9 • From week 0 to week 75 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.	6.3% 8/127 • Number of events 8 • From week 0 to week 75 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.	15.3% 13/85 • Number of events 14 • From week 0 to week 75 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.
Infections and infestations Upper respiratory tract infection	7.1% 9/126 • Number of events 11 • From week 0 to week 75 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.	15.0% 19/127 • Number of events 26 • From week 0 to week 75 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.	21.2% 18/85 • Number of events 23 • From week 0 to week 75 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.
Infections and infestations Urinary tract infection	5.6% 7/126 • Number of events 10 • From week 0 to week 75 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.	3.9% 5/127 • Number of events 5 • From week 0 to week 75 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.	2.4% 2/85 • Number of events 2 • From week 0 to week 75 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.
Gastrointestinal disorders Vomiting	25.4% 32/126 • Number of events 50 • From week 0 to week 75 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.	20.5% 26/127 • Number of events 34 • From week 0 to week 75 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.	5.9% 5/85 • Number of events 6 • From week 0 to week 75 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.

Additional Information

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Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER