Trial Outcomes & Findings for Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program (NCT NCT03611582)

NCT ID: NCT03611582

Last Updated: 2021-11-11

Results Overview

Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 611 participants
• Primary outcome timeframe: Baseline (week 0) to week 68
• Results posted on: 2021-11-11

Participant Flow

The trial was conducted in 41 sites in the United States.

The trial has a 68-week treatment period (16 weeks of dose escalation and 52 weeks of maintenance dose). Participants were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo.

Participant milestones

Measure	Semaglutide 2.4 mg Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Overall Study STARTED	407	204
Overall Study Full Analysis Set (FAS)	407	204
Overall Study Safety Analysis Set (SAS)	407	204
Overall Study COMPLETED	339	166
Overall Study NOT COMPLETED	68	38

Reasons for withdrawal

Measure	Semaglutide 2.4 mg Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Overall Study Adverse Event	26	6
Overall Study Protocol Violation	0	1
Overall Study Pregnancy	1	2
Overall Study Lack of Efficacy	0	1
Overall Study At the discretion of the investigator	1	0
Overall Study Safety concern as judged by the investigator	1	2
Overall Study Withdrawal by Subject	4	3
Overall Study Lost to Follow-up	18	7
Overall Study other	17	16

Baseline Characteristics

Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

Baseline characteristics by cohort

Measure	Semaglutide 2.4 mg n=407 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=204 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.	Total n=611 Participants Total of all reporting groups
Age, Continuous	46 Years STANDARD_DEVIATION 13 • n=5 Participants	46 Years STANDARD_DEVIATION 13 • n=7 Participants	46 Years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	315 Participants n=5 Participants	180 Participants n=7 Participants	495 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	24 Participants n=7 Participants	116 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	75 Participants n=5 Participants	46 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	332 Participants n=5 Participants	158 Participants n=7 Participants	490 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	80 Participants n=5 Participants	36 Participants n=7 Participants	116 Participants n=5 Participants
Race (NIH/OMB) White	307 Participants n=5 Participants	158 Participants n=7 Participants	465 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=407 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=204 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Body Weight (%) In-trial observation period	-16.5 Percentage Standard Deviation 10.1	-5.8 Percentage Standard Deviation 7.7
Change in Body Weight (%) On-treatment observation period	-17.6 Percentage Standard Deviation 9.6	-6.1 Percentage Standard Deviation 7.6

PRIMARY outcome

Timeframe: After 68 weeks

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

Number of participants who achieved greater than or equal to (≥) 5% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.

Outcome measures

Measure	Semaglutide 2.4 mg n=407 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=204 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% On-treatment observation period · Yes	300 Participants	82 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% In-trial observation period · Yes	323 Participants	90 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% In-trial observation period · No	50 Participants	99 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% On-treatment observation period · No	34 Participants	82 Participants

SECONDARY outcome

Timeframe: After 68 weeks

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Number of participants who achieved greater than or equal to (≥) 10% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=373 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=189 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10% Yes	281 Participants	51 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10% No	92 Participants	138 Participants

SECONDARY outcome

Timeframe: After 68 weeks

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Number of participants who achieved greater than or equal to (≥) 15% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=373 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=189 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15% Yes	208 Participants	25 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15% No	165 Participants	164 Participants

SECONDARY outcome

Timeframe: After 68 weeks

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Number of participants who achieved greater than or equal to (≥) 20% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 20% weight loss whereas 'No' infers number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=373 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=189 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20% No	240 Participants	182 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20% Yes	133 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=371 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=189 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Waist Circumference	-15.2 Centimeter (cm) Standard Deviation 10.2	-6.1 Centimeter (cm) Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=372 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=188 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Systolic Blood Pressure	-6 Millimeters of mercury (mmHg) Standard Deviation 14	-2 Millimeters of mercury (mmHg) Standard Deviation 15

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=407 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=204 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: Mental Health score	-0.5 Score on a scale Standard Deviation 6.0	-1.5 Score on a scale Standard Deviation 7.1
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in physical functioning score (SF-36)	2.5 Score on a scale Standard Deviation 5.7	1.7 Score on a scale Standard Deviation 5.7
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: Role-Physical score	1.6 Score on a scale Standard Deviation 6.5	1.5 Score on a scale Standard Deviation 6.7
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: Bodily Pain score	1.3 Score on a scale Standard Deviation 7.1	0.6 Score on a scale Standard Deviation 8.3
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: General Health score	3.4 Score on a scale Standard Deviation 6.6	1.9 Score on a scale Standard Deviation 6.4
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: Vitality score	2.0 Score on a scale Standard Deviation 8.2	0.9 Score on a scale Standard Deviation 7.8
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: Social Functioning score	0.1 Score on a scale Standard Deviation 6.6	-1.2 Score on a scale Standard Deviation 8.0
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: Physical component summary	3.2 Score on a scale Standard Deviation 6.0	2.6 Score on a scale Standard Deviation 6.5
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: Mental component summary	-0.9 Score on a scale Standard Deviation 6.0	-2.2 Score on a scale Standard Deviation 8.0
Change in Short Form-36 (SF-36) - Physical Functioning Score Change in SF-36: Role-Emotional score	-0.6 Score on a scale Standard Deviation 5.6	-1.5 Score on a scale Standard Deviation 7.7

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=373 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=189 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Body Weight (Kg)	-17.5 Kilogram (kg) Standard Deviation 11.4	-6.2 Kilogram (kg) Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=373 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=189 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Body Mass Index	-6.2 Kilogram per square meter (kg/sqm) Standard Deviation 4.0	-2.2 Kilogram per square meter (kg/sqm) Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=369 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=184 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in HbA1c (%)	-0.5 Percentage point of HbA1c Standard Deviation 0.3	-0.3 Percentage point of HbA1c Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=369 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=184 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in HbA1c (mmol/Mol)	-5.8 mmol/mol Standard Deviation 3.1	-3.1 mmol/mol Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in fasting plasma glucose from week 0 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=355 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=176 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Fasting Plasma Glucose	-7.3 milligrams per deciliter (mg/dL) Standard Deviation 10.9	-1.1 milligrams per deciliter (mg/dL) Standard Deviation 10.6

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in fasting serum insulin from week 0 to week 68 [measured as milli-international units per milliliter (mIU/mL)] is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=346 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=170 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Fasting Serum Insulin	0.68 Ratio of fasting serum insulin Geometric Coefficient of Variation 67.4	0.84 Ratio of fasting serum insulin Geometric Coefficient of Variation 50.6

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=372 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=188 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Diastolic Blood Pressure	-3 mmHg Standard Deviation 10	-1 mmHg Standard Deviation 10

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in fasting total cholesterol from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=363 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=181 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Total Cholesterol	0.96 Ratio of fasting total cholesterol Geometric Coefficient of Variation 15.0	1.01 Ratio of fasting total cholesterol Geometric Coefficient of Variation 12.3

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in fasting HDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=363 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=181 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in High-density Lipoproteins (HDL)	1.06 Ratio of fasting HDL cholesterol Geometric Coefficient of Variation 14.6	1.05 Ratio of fasting HDL cholesterol Geometric Coefficient of Variation 15.0

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in fasting LDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=363 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=181 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Low-density Lipoproteins (LDL)	0.96 Ratio of fasting LDL cholesterol Geometric Coefficient of Variation 23.2	1.01 Ratio of fasting LDL cholesterol Geometric Coefficient of Variation 18.6

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in fasting VLDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=363 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=181 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Very Low Density Lipoprotein (VLDL)	0.77 Ratio of fasting VLDL cholesterol Geometric Coefficient of Variation 40.9	0.91 Ratio of fasting VLDL cholesterol Geometric Coefficient of Variation 38.6

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in fasting free fatty acids from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=346 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=171 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Free Fatty Acids	0.86 Ratio of fasting free fatty acids Geometric Coefficient of Variation 69.9	1.08 Ratio of fasting free fatty acids Geometric Coefficient of Variation 71.8

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in fasting triglycerides from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=363 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=181 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Triglycerides	0.77 Ratio of fasting triglycerides Geometric Coefficient of Variation 41.3	0.91 Ratio of fasting triglycerides Geometric Coefficient of Variation 39.1

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=363 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=182 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in High Sensitivity C-reactive Protein	0.40 milligrams per litre (mg/L) Geometric Coefficient of Variation 108.7	0.76 milligrams per litre (mg/L) Geometric Coefficient of Variation 75.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=343 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=162 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Plasminogen Activator Inhibitor-1 Activity	0.92 Arbritary units per milliliter (AU/ml) Geometric Coefficient of Variation 80.6	1.26 Arbritary units per milliliter (AU/ml) Geometric Coefficient of Variation 74.2

SECONDARY outcome

Timeframe: After 68 weeks

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which is uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=364 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=181 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score Yes (with threshold 4.3)	86 Participants	36 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score No (with threshold 4.3)	278 Participants	145 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score Yes (with threshold 3.7)	133 Participants	51 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score No (with threshold 3.7)	231 Participants	130 Participants

SECONDARY outcome

Timeframe: Baseline (week 0) to week 8

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.

Change in body weight from baseline (week 0) to week 8 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=396 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=197 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Body Weight	-7.8 Percentage Standard Deviation 3.1	-6.0 Percentage Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline (week 0) to week 75

Population: SAS included all participants who received at least one dose of trial product.

An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=407 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=204 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Number of Treatment-emergent Adverse Events (AEs)	4035 events	1325 events

SECONDARY outcome

Timeframe: Baseline (week 0) to week 75

Population: SAS included all participants who received at least one dose of trial product.

A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=407 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=204 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Number of Serious Adverse Events (SAEs)	55 events	7 events

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.

Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=334 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=163 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Pulse	3 beats per minute (bpm) Standard Deviation 11	2 beats per minute (bpm) Standard Deviation 10

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.

Change in amylase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=332 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=161 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Amylase	1.12 Ratio of amylase Geometric Coefficient of Variation 19	1.07 Ratio of amylase Geometric Coefficient of Variation 18.1

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.

Change in lipase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=332 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=161 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Lipase	1.31 Ratio of lipase Geometric Coefficient of Variation 52	0.94 Ratio of lipase Geometric Coefficient of Variation 39.4

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.

Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=332 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=162 Participants Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Change in Calcitonin	0.93 Ratio of calcitonin Geometric Coefficient of Variation 40.6	0.94 Ratio of calcitonin Geometric Coefficient of Variation 33.2

Adverse Events

Semaglutide 2.4 mg

Serious events: 37 serious events

Other events: 379 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 177 other events

Deaths: 0 deaths

Serious adverse events

Measure	Semaglutide 2.4 mg n=407 participants at risk Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=204 participants at risk Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Infections and infestations Abdominal abscess	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Abdominal pain	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Psychiatric disorders Anxiety	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Appendicitis	0.74% 3/407 • Number of events 4 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Biliary dyskinesia	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Castleman's disease	0.00% 0/407 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.49% 1/204 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Cellulitis	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Cerebral infarction	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.49% 2/407 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Cholecystitis	0.49% 2/407 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Cholecystitis acute	0.74% 3/407 • Number of events 3 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Cholelithiasis	1.7% 7/407 • Number of events 7 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Vascular disorders Deep vein thrombosis	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Gastroenteritis viral	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Haemorrhoids thrombosed	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Hip fracture	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Renal and urinary disorders Hydronephrosis	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/407 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.49% 1/204 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Inguinal hernia	0.00% 0/407 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.49% 1/204 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/407 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.49% 1/204 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Blood and lymphatic system disorders Iron deficiency anaemia	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Joint dislocation	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Large intestine infection	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Surgical and medical procedures Neck dissection	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Renal and urinary disorders Nephrolithiasis	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
General disorders Non-cardiac chest pain	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Metabolism and nutrition disorders Obesity	0.00% 0/407 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.49% 1/204 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.74% 3/407 • Number of events 4 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Overdose	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Pelvic inflammatory disease	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Pneumonia	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Sepsis	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/407 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.49% 1/204 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Spinal compression fracture	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Syncope	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Transient ischaemic attack	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/407 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.49% 1/204 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Urinary tract infection	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Ear and labyrinth disorders Vertigo	0.25% 1/407 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.00% 0/204 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.

Other adverse events

Measure	Semaglutide 2.4 mg n=407 participants at risk Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.	Placebo n=204 participants at risk Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.
Gastrointestinal disorders Abdominal distension	10.1% 41/407 • Number of events 55 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	9.8% 20/204 • Number of events 28 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Abdominal pain	13.0% 53/407 • Number of events 75 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	4.9% 10/204 • Number of events 11 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Abdominal pain upper	8.1% 33/407 • Number of events 45 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	2.5% 5/204 • Number of events 5 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	9.6% 39/407 • Number of events 54 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	9.3% 19/204 • Number of events 23 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Back pain	13.0% 53/407 • Number of events 67 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	10.8% 22/204 • Number of events 24 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Constipation	36.9% 150/407 • Number of events 210 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	24.5% 50/204 • Number of events 62 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Metabolism and nutrition disorders Decreased appetite	8.6% 35/407 • Number of events 36 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	3.4% 7/204 • Number of events 7 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Diarrhoea	36.1% 147/407 • Number of events 307 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	22.1% 45/204 • Number of events 62 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Dizziness	12.8% 52/407 • Number of events 73 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	5.4% 11/204 • Number of events 14 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Dyspepsia	8.8% 36/407 • Number of events 47 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	4.9% 10/204 • Number of events 15 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Eructation	8.8% 36/407 • Number of events 52 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	0.49% 1/204 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
General disorders Fatigue	12.8% 52/407 • Number of events 69 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	7.4% 15/204 • Number of events 19 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Flatulence	11.5% 47/407 • Number of events 62 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	11.3% 23/204 • Number of events 24 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Gastroenteritis	6.9% 28/407 • Number of events 32 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	5.9% 12/204 • Number of events 19 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Gastroenteritis viral	10.1% 41/407 • Number of events 46 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	6.4% 13/204 • Number of events 13 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.1% 25/407 • Number of events 32 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	2.0% 4/204 • Number of events 4 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Headache	19.2% 78/407 • Number of events 123 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	9.8% 20/204 • Number of events 25 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Influenza	6.6% 27/407 • Number of events 32 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	5.4% 11/204 • Number of events 11 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Nasopharyngitis	22.1% 90/407 • Number of events 128 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	24.0% 49/204 • Number of events 70 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Nausea	58.2% 237/407 • Number of events 511 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	22.1% 45/204 • Number of events 60 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.2% 13/407 • Number of events 17 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	5.9% 12/204 • Number of events 12 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	4.2% 17/407 • Number of events 17 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	6.4% 13/204 • Number of events 14 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Immune system disorders Seasonal allergy	2.9% 12/407 • Number of events 18 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	5.4% 11/204 • Number of events 14 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Sinusitis	9.6% 39/407 • Number of events 51 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	12.7% 26/204 • Number of events 34 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Upper respiratory tract infection	20.9% 85/407 • Number of events 115 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	21.6% 44/204 • Number of events 65 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Urinary tract infection	10.1% 41/407 • Number of events 60 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	4.9% 10/204 • Number of events 11 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Vomiting	27.3% 111/407 • Number of events 212 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.	10.8% 22/204 • Number of events 25 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

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