Trial Outcomes & Findings for STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (NCT NCT03548935)

NCT ID: NCT03548935

Last Updated: 2021-11-19

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 observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1961 participants
• Primary outcome timeframe: Baseline (week 0) to week 68
• Results posted on: 2021-11-19

Participant Flow

The trial was conducted at 129 sites in 16 countries as follows (all sites screened and randomized): Argentina (5 sites), Belgium (5 sites), Bulgaria (5 sites), Canada (7 sites), Denmark (1 site), Finland (2 sites), France (7 sites), Germany (13 sites), India (13 sites), Japan (5 sites), Mexico (3 sites), Poland (4 sites), Russian Federation (8 sites), Taiwan(1 site), UK (10 sites), US (40 sites).

The trial included an initial 16-week dose-escalation period and a 52-week dose maintenance period. Participants were randomized in 2:1 ratio either to receive semaglutide 2.4 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.

Participant milestones

Measure	Semaglutide 2.4 mg Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Study STARTED	1306	655
Overall Study Full Analysis Set (FAS)	1306	655
Overall Study Safety Analysis Set (SAS)	1306	655
Overall Study COMPLETED	1240	609
Overall Study NOT COMPLETED	66	46

Reasons for withdrawal

Measure	Semaglutide 2.4 mg Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Study Withdrawal by Subject	26	17
Overall Study Lost to Follow-up	39	28
Overall Study Death	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Semaglutide 2.4 mg n=1306 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=655 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Total n=1961 Participants Total of all reporting groups
Age, Continuous	46 Years STANDARD_DEVIATION 13 • n=93 Participants	47 Years STANDARD_DEVIATION 12 • n=4 Participants	46 Years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	955 Participants n=93 Participants	498 Participants n=4 Participants	1453 Participants n=27 Participants
Sex: Female, Male Male	351 Participants n=93 Participants	157 Participants n=4 Participants	508 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	150 Participants n=93 Participants	86 Participants n=4 Participants	236 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1118 Participants n=93 Participants	551 Participants n=4 Participants	1669 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	38 Participants n=93 Participants	18 Participants n=4 Participants	56 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	17 Participants n=93 Participants	10 Participants n=4 Participants	27 Participants n=27 Participants
Race (NIH/OMB) Asian	181 Participants n=93 Participants	80 Participants n=4 Participants	261 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Black or African American	72 Participants n=93 Participants	39 Participants n=4 Participants	111 Participants n=27 Participants
Race (NIH/OMB) White	973 Participants n=93 Participants	499 Participants n=4 Participants	1472 Participants n=27 Participants
Race (NIH/OMB) More than one race	25 Participants n=93 Participants	8 Participants n=4 Participants	33 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	38 Participants n=93 Participants	17 Participants n=4 Participants	55 Participants n=27 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 observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=1306 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=655 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Weight (%) In-trial observation period	-15.6 Percentage point Standard Deviation 10.1	-2.8 Percentage point Standard Deviation 6.5
Change in Body Weight (%) On-treatment observation period	-16.9 Percentage point Standard Deviation 9.4	-3.1 Percentage point Standard Deviation 6.4

PRIMARY outcome

Timeframe: After 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.

Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.

Outcome measures

Measure	Semaglutide 2.4 mg n=1306 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=655 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) In-trial observation period · Yes	1047 Participants	182 Participants
Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) In-trial observation period · No	165 Participants	395 Participants
Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) On-treatment observation period · Yes	978 Participants	165 Participants
Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) On-treatment observation period · No	81 Participants	334 Participants

SECONDARY outcome

Timeframe: Week 68

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

Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1212 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=577 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) Yes	838 Participants	69 Participants
Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) No	374 Participants	508 Participants

SECONDARY outcome

Timeframe: Week 68

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

Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1212 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=577 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) Yes	612 Participants	28 Participants
Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) No	600 Participants	549 Participants

SECONDARY outcome

Timeframe: Week 68

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

Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1212 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=577 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) Yes	388 Participants	10 Participants
Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) No	824 Participants	567 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 randomization (week 0) to date of last contact with trial site (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1210 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=575 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Waist Circumference (cm)	-14.1 Centimeter (cm) Standard Deviation 9.6	-4.4 Centimeter (cm) Standard Deviation 6.9

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 randomization (week 0) to date of last contact with trial site (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1210 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=574 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Systolic Blood Pressure (mmHg)	-7 Millimeters of mercury (mmHg) Standard Deviation 14	-1 Millimeters of mercury (mmHg) Standard Deviation 13

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1195 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=566 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Short Form 36 (SF-36) Change in SF-36 (bodily pain score)	0.5 Score on a scale Standard Deviation 8.2	-1.3 Score on a scale Standard Deviation 8.9
Change in Short Form 36 (SF-36) Change in physical functioning score (SF-36)	2.3 Score on a scale Standard Deviation 6.6	0.4 Score on a scale Standard Deviation 7.4
Change in Short Form 36 (SF-36) Change in SF-36 (role-physical score)	1.1 Score on a scale Standard Deviation 7.2	-0.2 Score on a scale Standard Deviation 7.2
Change in Short Form 36 (SF-36) Change in SF-36 (general health score)	2.0 Score on a scale Standard Deviation 7.2	-0.6 Score on a scale Standard Deviation 7.1
Change in Short Form 36 (SF-36) Change in SF-36 (vitality score)	0.7 Score on a scale Standard Deviation 8.0	-1.3 Score on a scale Standard Deviation 7.9
Change in Short Form 36 (SF-36) Change in SF-36 (social functioning score)	-0.3 Score on a scale Standard Deviation 6.6	-1.4 Score on a scale Standard Deviation 7.4
Change in Short Form 36 (SF-36) Change in SF-36 (role-emotional score)	-0.9 Score on a scale Standard Deviation 7.3	-1.5 Score on a scale Standard Deviation 7.6
Change in Short Form 36 (SF-36) Change in SF-36 (mental health score)	-0.8 Score on a scale Standard Deviation 7.0	-1.7 Score on a scale Standard Deviation 7.4
Change in Short Form 36 (SF-36) Change in SF-36 (physical component summary)	2.4 Score on a scale Standard Deviation 6.7	0.2 Score on a scale Standard Deviation 7.1
Change in Short Form 36 (SF-36) Change in SF-36 (mental component summary)	-1.5 Score on a scale Standard Deviation 7.1	-2.1 Score on a scale Standard Deviation 7.7

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1193 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=566 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score Change in physical function domain score	15.0 Score on a scale Standard Deviation 21.6	6.0 Score on a scale Standard Deviation 21.1
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score Change in physical domain score	14.0 Score on a scale Standard Deviation 20.0	5.0 Score on a scale Standard Deviation 19.5
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score Change in psychosocial domain score	17.4 Score on a scale Standard Deviation 19.2	6.9 Score on a scale Standard Deviation 17.8
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score Change in total score	16.2 Score on a scale Standard Deviation 17.8	6.3 Score on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomized 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 randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1212 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=577 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Weight (kg)	-16.1 Kilogram (kg) Standard Deviation 10.6	-2.9 Kilogram (kg) Standard Deviation 7.2

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 randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1212 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=577 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Mass Index (BMI) (kg/m2)	-5.8 Kilogram per square meter (kg/sqm) Standard Deviation 3.8	-1.0 Kilogram per square meter (kg/sqm) Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomized 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 randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1197 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=563 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in HbA1C (%)	-0.5 Percentage point of HbA1c Standard Deviation 0.3	-0.2 Percentage point of HbA1c Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomized 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 randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1197 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=563 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in HbA1C (mmol/Mol)	-5.1 millimoles per mole (mmol/mol) Standard Deviation 3.3	-1.8 millimoles per mole (mmol/mol) Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1175 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=557 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Fasting Plasma Glucose (FPG) (mg/dL)	-9.2 milligrams per deciliter (mg/dL) Standard Deviation 10.9	-0.4 milligrams per deciliter (mg/dL) Standard Deviation 12.7

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1147 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=550 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline	0.73 Ratio of fasting serum insulin Geometric Coefficient of Variation 62.3	0.92 Ratio of fasting serum insulin Geometric Coefficient of Variation 56.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomized 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 randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1210 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=574 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Diastolic Blood Pressure (mmHg)	-3 Millimeters of mercury (mmHg) Standard Deviation 9	-1 Millimeters of mercury (mmHg) Standard Deviation 9

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1196 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=561 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Total Cholesterol (mg/dL) - Ratio to Baseline	0.96 Ratio of total cholesterol Geometric Coefficient of Variation 14.8	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 15.5

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1192 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=558 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline	1.05 Ratio of HDL cholesterol Geometric Coefficient of Variation 16.1	1.02 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.9

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1194 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=561 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline	0.97 Ratio of LDL cholesterol Geometric Coefficient of Variation 23.7	1.01 Ratio of LDL cholesterol Geometric Coefficient of Variation 25.5

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1193 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=561 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline	0.77 Ratio of VLDL cholesterol Geometric Coefficient of Variation 37.7	0.92 Ratio of VLDL cholesterol Geometric Coefficient of Variation 35.2

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1154 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=552 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline	0.83 Ratio of free fatty acids Geometric Coefficient of Variation 78.3	0.93 Ratio of free fatty acids Geometric Coefficient of Variation 70.8

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1194 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=561 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Triglycerides (mg/dL) - Ratio to Baseline	0.77 Ratio of triglycerides Geometric Coefficient of Variation 38.3	0.92 Ratio of triglycerides Geometric Coefficient of Variation 36.2

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1200 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=562 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline	0.45 Ratio of hsCRP Geometric Coefficient of Variation 128.2	0.84 Ratio of hsCRP Geometric Coefficient of Variation 102.5

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 as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1131 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=546 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline	1.15 Ratio of PAI-1 Geometric Coefficient of Variation 86.5	1.53 Ratio of PAI-1 Geometric Coefficient of Variation 77.3

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1194 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=562 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline	1.07 Ratio of soluble leptin receptor Geometric Coefficient of Variation 24.9	1.02 Ratio of soluble leptin receptor Geometric Coefficient of Variation 22.2

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1197 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=563 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Leptin (ng/mL) - Ratio to Baseline	0.52 Ratio of leptin Geometric Coefficient of Variation 75.9	0.87 Ratio of leptin Geometric Coefficient of Variation 52.7

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.

Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=83 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=39 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Composition (Total Fat Mass) (%)	-3.9 Percentage point Standard Deviation 5.4	-0.3 Percentage point Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.

Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=83 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=39 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Composition (Total Fat Mass) (kg)	-9.3 Kilograms Standard Deviation 8.5	-1.5 Kilograms Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.

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

Outcome measures

Measure	Semaglutide 2.4 mg n=83 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=39 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Composition (Lean Body Mass) (%)	3.4 Percentage point Standard Deviation 5.1	0.2 Percentage point Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.

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

Outcome measures

Measure	Semaglutide 2.4 mg n=83 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=39 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Composition (Lean Body Mass) (kg)	-5.8 Kilograms Standard Deviation 4.6	-1.8 Kilograms Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.

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

Outcome measures

Measure	Semaglutide 2.4 mg n=83 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=39 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Composition (Visceral Fat Mass) (%)	-2.2 Percentage point Standard Deviation 4.4	-0.1 Percentage point Standard Deviation 4.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.

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

Outcome measures

Measure	Semaglutide 2.4 mg n=83 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=39 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Composition (Visceral Fat Mass) (kg)	-0.4 Kilograms Standard Deviation 0.3	-0.1 Kilograms Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.

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

Outcome measures

Measure	Semaglutide 2.4 mg n=89 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=42 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Weight (%) - DEXA Subpopulation	-15.8 Percentage point Standard Deviation 11.1	-3.4 Percentage point Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.

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

Outcome measures

Measure	Semaglutide 2.4 mg n=89 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=42 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Weight (kg) - DEXA Subpopulation	-15.5 Kilograms Standard Deviation 11.4	-3.2 Kilograms Standard Deviation 6.1

SECONDARY outcome

Timeframe: After week 68

Population: FAS included all randomized 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 different thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1195 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=566 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score Yes (with threshold 4.3)	318 Participants	97 Participants
Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score No (with threshold 4.3)	877 Participants	469 Participants
Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score Yes (with threshold 3.7)	478 Participants	153 Participants
Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score No (with threshold 3.7)	717 Participants	413 Participants

SECONDARY outcome

Timeframe: After week 68

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

The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).

Outcome measures

Measure	Semaglutide 2.4 mg n=1193 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=566 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score Yes (with threshold 20)	473 Participants	145 Participants
Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score No (with threshold 20)	720 Participants	421 Participants
Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score Yes (with threshold 14.6)	611 Participants	186 Participants
Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score No (with threshold 14.6)	582 Participants	380 Participants

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 for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=1306 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=655 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Number of Treatment Emergent Adverse Events (TEAEs)	9658 Events	3302 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=1306 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=655 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Number of Serious Adverse Events (SAEs)	164 Events	53 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=1059 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=499 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Pulse	3 beats per minute (bpm) Standard Deviation 10	-1 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 units per litre [U/L]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).

Outcome measures

Measure	Semaglutide 2.4 mg n=1053 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=497 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Amylase - Ratio to Baseline	1.14 Ratio of amylase Geometric Coefficient of Variation 21.6	1.03 Ratio of amylase Geometric Coefficient of Variation 21.4

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

Outcome measures

Measure	Semaglutide 2.4 mg n=1053 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=496 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Lipase - Ratio to Baseline	1.41 Ratio of lipase Geometric Coefficient of Variation 49.3	0.97 Ratio of lipase Geometric Coefficient of Variation 37.3

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=1050 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=497 Participants Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Calcitonin - Ratio to Baseline	0.99 Ratio of calcitonin Geometric Coefficient of Variation 37.6	0.95 Ratio of calcitonin Geometric Coefficient of Variation 40.9

Adverse Events

Sema 2.4 mg

Serious events: 128 serious events

Other events: 1052 other events

Deaths: 1 deaths

Placebo

Serious events: 42 serious events

Other events: 447 other events

Deaths: 1 deaths

Serious adverse events

Measure	Sema 2.4 mg n=1306 participants at risk Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=655 participants at risk Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Musculoskeletal and connective tissue disorders Back pain	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Bacterial colitis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Bile duct stone	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Abdominal hernia	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Abdominal pain	0.23% 3/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Abdominal pain lower	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Surgical and medical procedures Abdominoplasty	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Skin and subcutaneous tissue disorders Actinic keratosis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Acute myocardial infarction	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Acute sinusitis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Psychiatric disorders Acute stress disorder	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Blood and lymphatic system disorders Anaemia	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Anal fistula	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Angina pectoris	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Angina unstable	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Ankle fracture	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Psychiatric disorders Anxiety	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Aphasia	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Appendicitis	0.38% 5/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Appendicitis perforated	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Arthritis infective	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.31% 2/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Atrial fibrillation	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Atrial tachycardia	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Surgical and medical procedures Bone prosthesis insertion	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Renal and urinary disorders Calculus urinary	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Cardiomyopathy	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Cellulitis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Cerebral infarction	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
General disorders Chest pain	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Surgical and medical procedures Cholecystectomy	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Cholecystitis	0.31% 4/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Cholecystitis acute	0.23% 3/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Cholelithiasis	0.92% 12/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Chronic sinusitis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Colitis	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Colitis ischaemic	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Constipation	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Coronary artery stenosis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Costochondritis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Cranial nerve disorder	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Cytomegalovirus infection	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Vascular disorders Deep vein thrombosis	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Device related infection	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Diarrhoea	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Eye disorders Diplopia	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Dizziness	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Duodenal ulcer	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Empyema	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Enteritis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Femur fracture	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Surgical and medical procedures Gastric bypass	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Gastroenteritis	0.38% 5/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Gastroenteritis astroviral	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Metabolism and nutrition disorders Gout	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Vascular disorders Haematoma	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy cell leukaemia	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Headache	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Hepatitis E	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Hiatus hernia	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Skin and subcutaneous tissue disorders Hidradenitis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Surgical and medical procedures Hip surgery	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Immune system disorders Hypersensitivity	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Hepatobiliary disorders Hypertransaminasaemia	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Idiopathic intracranial hypertension	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Surgical and medical procedures Intervertebral disc operation	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Ischaemic stroke	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Large intestine infection	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Large intestine perforation	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Ligament rupture	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Investigations Lipase increased	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Ear and labyrinth disorders Meniere's disease	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Meningitis viral	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Meniscus injury	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Muscular weakness	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Myalgia intercostal	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Myocardial infarction	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.31% 2/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Myocarditis	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Nausea	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Renal and urinary disorders Nephrolithiasis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Nerve compression	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Neutropenic sepsis	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
General disorders Non-cardiac chest pain	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Oesophageal achalasia	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Eye disorders Optic ischaemic neuropathy	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.23% 3/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.31% 2/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Reproductive system and breast disorders Ovarian cyst	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Cardiac disorders Palpitations	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Pancreatitis acute	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Peroneal nerve palsy	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Pneumonia	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.31% 2/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Procedural haemorrhage	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Psychogenic seizure	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.31% 2/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Pyelonephritis	0.15% 2/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
General disorders Pyrexia	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Radius fracture	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Respiratory syncytial virus infection	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Respiratory tract infection	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Rib fracture	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Road traffic accident	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Septic shock	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Sinusitis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Blood and lymphatic system disorders Splenic haemorrhage	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Staphylococcal infection	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Staphylococcal sepsis	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Subcutaneous abscess	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Subdural haematoma	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Psychiatric disorders Suicidal ideation	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Psychiatric disorders Suicide attempt	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Injury, poisoning and procedural complications Tibia fracture	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Tonsillitis	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Toxoplasmosis	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Urinary tract infection	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Reproductive system and breast disorders Uterine haemorrhage	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
General disorders Vascular stent occlusion	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Ear and labyrinth disorders Vertigo	0.23% 3/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Vertigo CNS origin	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Volvulus	0.08% 1/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Vomiting	0.31% 4/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.00% 0/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Investigations Weight increased	0.00% 0/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.15% 1/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.

Other adverse events

Measure	Sema 2.4 mg n=1306 participants at risk Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=655 participants at risk Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Gastrointestinal disorders Abdominal distension	7.4% 96/1306 • Number of events 135 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	4.7% 31/655 • Number of events 42 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Abdominal pain	9.7% 127/1306 • Number of events 172 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	5.5% 36/655 • Number of events 41 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Abdominal pain upper	9.6% 125/1306 • Number of events 176 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	5.3% 35/655 • Number of events 37 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 81/1306 • Number of events 92 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	6.6% 43/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Musculoskeletal and connective tissue disorders Back pain	8.1% 106/1306 • Number of events 120 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	8.1% 53/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Constipation	23.4% 305/1306 • Number of events 389 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	9.5% 62/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 40/1306 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	5.0% 33/655 • Number of events 35 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Metabolism and nutrition disorders Decreased appetite	9.5% 124/1306 • Number of events 139 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	3.4% 22/655 • Number of events 26 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Diarrhoea	31.5% 411/1306 • Number of events 765 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	15.9% 104/655 • Number of events 138 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Dizziness	7.5% 98/1306 • Number of events 129 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	3.5% 23/655 • Number of events 35 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Dyspepsia	10.3% 135/1306 • Number of events 179 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	3.5% 23/655 • Number of events 30 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Eructation	8.6% 112/1306 • Number of events 139 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	0.46% 3/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
General disorders Fatigue	8.0% 104/1306 • Number of events 120 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	4.3% 28/655 • Number of events 29 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Gastroenteritis	6.2% 81/1306 • Number of events 99 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	4.6% 30/655 • Number of events 38 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.3% 82/1306 • Number of events 92 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	3.1% 20/655 • Number of events 21 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Nervous system disorders Headache	15.2% 198/1306 • Number of events 386 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	12.2% 80/655 • Number of events 104 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Influenza	6.8% 89/1306 • Number of events 112 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	9.6% 63/655 • Number of events 79 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Nasopharyngitis	21.5% 281/1306 • Number of events 480 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	20.3% 133/655 • Number of events 216 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Nausea	44.1% 576/1306 • Number of events 1067 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	17.4% 114/655 • Number of events 146 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Sinusitis	5.4% 70/1306 • Number of events 83 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	5.5% 36/655 • Number of events 40 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Upper respiratory tract infection	8.7% 114/1306 • Number of events 158 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	12.2% 80/655 • Number of events 116 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Infections and infestations Urinary tract infection	5.2% 68/1306 • Number of events 83 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	4.3% 28/655 • Number of events 33 • 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 randomized treatment and no later than the date of last dose + 7 weeks.
Gastrointestinal disorders Vomiting	24.6% 321/1306 • Number of events 632 • 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 randomized treatment and no later than the date of last dose + 7 weeks.	6.6% 43/655 • 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 randomized treatment and no later than the date of last dose + 7 weeks.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

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