Trial Outcomes & Findings for Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity (NCT NCT03552757)

NCT ID: NCT03552757

Last Updated: 2021-11-09

Results Overview

Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1210 participants
• Primary outcome timeframe: Baseline (week 0) to week 68
• Results posted on: 2021-11-09

Participant Flow

The trial was conducted at 149 sites in 12 countries as follows: Argentina (5 sites), Canada (10 sites), Germany (9 sites), Greece (6 sites), India (18 sites), Japan (12 sites), Russian Federation (9 sites), South Africa (6 sites), Spain (8 sites), United Arab Emirates (5 sites), United Kingdom (10 sites) and United States (51 sites).

Participants were randomised in 1:1:1 ratio to receive either 'semaglutide 2.4 milligram (mg) and placebo II (placebo matched to semaglutide 1.0 mg) once weekly', 'semaglutide 1.0 mg and placebo I (placebo matched to semaglutide 2.4 mg) once weekly' or 'placebo I and placebo II once weekly'.

Participant milestones

Measure	Semaglutide 1.0 mg Participants received once-weekly subcutaneous (s.c; under the skin) semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Study STARTED	403	404	403
Overall Study Exposed	402	403	402
Overall Study Full Analysis Set (FAS)	403	404	403
Overall Study Safety Analysis Set (SAS)	402	403	402
Overall Study COMPLETED	390	391	383
Overall Study NOT COMPLETED	13	13	20

Reasons for withdrawal

Measure	Semaglutide 1.0 mg Participants received once-weekly subcutaneous (s.c; under the skin) semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Overall Study Withdrawal by Subject	10	5	12
Overall Study Lost to Follow-up	2	7	7
Overall Study Death	1	1	1

Baseline Characteristics

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

Baseline characteristics by cohort

Measure	Semaglutide 1.0 mg n=403 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=404 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=403 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Total n=1210 Participants Total of all reporting groups
Age, Continuous	56 Year STANDARD_DEVIATION 10 • n=5 Participants	55 Year STANDARD_DEVIATION 11 • n=7 Participants	55 Year STANDARD_DEVIATION 11 • n=5 Participants	55 Year STANDARD_DEVIATION 11 • n=4 Participants
Sex: Female, Male Female	203 Participants n=5 Participants	223 Participants n=7 Participants	190 Participants n=5 Participants	616 Participants n=4 Participants
Sex: Female, Male Male	200 Participants n=5 Participants	181 Participants n=7 Participants	213 Participants n=5 Participants	594 Participants n=4 Participants
Race/Ethnicity, Customized White	272 Participants n=5 Participants	237 Participants n=7 Participants	242 Participants n=5 Participants	751 Participants n=4 Participants
Race/Ethnicity, Customized Asian	97 Participants n=5 Participants	112 Participants n=7 Participants	108 Participants n=5 Participants	317 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	28 Participants n=5 Participants	35 Participants n=7 Participants	37 Participants n=5 Participants	100 Participants n=4 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	35 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Not Applicable	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	344 Participants n=5 Participants	357 Participants n=7 Participants	354 Participants n=5 Participants	1055 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	59 Participants n=5 Participants	47 Participants n=7 Participants	49 Participants n=5 Participants	155 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (week 0) to week 68

Population: Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data.

Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Outcome measures

Measure	Placebo n=403 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=404 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo In-trial observation period	-3.3 Percentage point of body weight Standard Deviation 5.5	-9.9 Percentage point of body weight Standard Deviation 8.0	—
Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo On-treatment observation period	-3.1 Percentage point of body weight Standard Deviation 5.2	-10.7 Percentage point of body weight Standard Deviation 7.8	—

PRIMARY outcome

Timeframe: At week 68

Population: Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data.

Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Outcome measures

Measure	Placebo n=403 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=404 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo In-trial observation period · Yes	107 Participants	267 Participants	—
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo In-trial observation period · No	269 Participants	121 Participants	—
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo On-treatment observation period · Yes	94 Participants	257 Participants	—
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo On-treatment observation period · No	246 Participants	94 Participants	—

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=380 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=388 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg	-7.2 Percentage point of body weight Standard Deviation 6.6	-9.9 Percentage point of body weight Standard Deviation 8.0	—

SECONDARY outcome

Timeframe: At week 68

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

Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=380 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=388 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg Yes	217 Participants	267 Participants	—
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg No	163 Participants	121 Participants	—

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=387 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=380 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=375 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Waist Circumference	-9.7 Centimetre (cm) Standard Deviation 8.1	-6.9 Centimetre (cm) Standard Deviation 6.8	-4.3 Centimetre (cm) Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=388 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=380 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Body Weight (Kg)	-9.9 Kilogram (kg) Standard Deviation 8.5	-7.1 Kilogram (kg) Standard Deviation 6.7	-3.4 Kilogram (kg) Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=388 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=380 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in BMI	-3.6 kilogram per square meter (kg/m^2) Standard Deviation 3.1	-2.6 kilogram per square meter (kg/m^2) Standard Deviation 2.4	-1.2 kilogram per square meter (kg/m^2) Standard Deviation 2.1

SECONDARY outcome

Timeframe: At week 68

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

Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=388 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=380 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% Yes	177 Participants	109 Participants	31 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% No	211 Participants	271 Participants	345 Participants

SECONDARY outcome

Timeframe: At week 68

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

Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=388 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=380 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% Yes	100 Participants	52 Participants	12 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% No	288 Participants	328 Participants	364 Participants

SECONDARY outcome

Timeframe: At week 68

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

Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=388 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=380 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% Yes	51 Participants	18 Participants	6 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% No	337 Participants	362 Participants	370 Participants

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=381 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=376 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=374 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in HbA1c (%)	-1.7 Percentage point of HbA1c Standard Deviation 1.2	-1.5 Percentage point of HbA1c Standard Deviation 1.1	-0.3 Percentage point of HbA1c Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=381 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=376 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=374 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in HbA1c (mmol/Mol)	-18.7 millimoles per mole (mmol/mol) Standard Deviation 13.0	-16.9 millimoles per mole (mmol/mol) Standard Deviation 12.3	-3.4 millimoles per mole (mmol/mol) Standard Deviation 14.3

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=375 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=367 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=370 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in FPG (mg/dL)	-37.9 milligrams per deciliter (mg/dL) Standard Deviation 45.9	-36.5 milligrams per deciliter (mg/dL) Standard Deviation 45.1	-2.3 milligrams per deciliter (mg/dL) Standard Deviation 53.1

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=360 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=352 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=351 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Fasting Serum Insulin	0.90 Picomoles per litre (pmol/L) Geometric Coefficient of Variation 65.4	0.94 Picomoles per litre (pmol/L) Geometric Coefficient of Variation 59.8	0.93 Picomoles per litre (pmol/L) Geometric Coefficient of Variation 53.6

SECONDARY outcome

Timeframe: At week 68

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

Number of participants who achieved HbA1c <7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=381 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=376 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=374 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol) Yes	299 Participants	272 Participants	99 Participants
Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol) No	82 Participants	104 Participants	275 Participants

SECONDARY outcome

Timeframe: At week 68

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

Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=381 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=376 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=374 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol) Yes	257 Participants	226 Participants	58 Participants
Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol) No	124 Participants	150 Participants	316 Participants

SECONDARY outcome

Timeframe: At week 68

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

Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=381 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=376 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=374 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0% Yes	170 Participants	105 Participants	25 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0% No	211 Participants	271 Participants	349 Participants

SECONDARY outcome

Timeframe: At week 68

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

Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=381 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=376 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=374 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0% Yes	98 Participants	49 Participants	11 Participants
Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0% No	283 Participants	327 Participants	363 Participants

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=387 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=379 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Systolic Blood Pressure	-4 Millimetre of mercury (mmHg) Standard Deviation 14	-3 Millimetre of mercury (mmHg) Standard Deviation 15	0 Millimetre of mercury (mmHg) Standard Deviation 15

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=387 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=379 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Diastolic Blood Pressure	-2 Millimetre of mercury (mmHg) Standard Deviation 9	-1 Millimetre of mercury (mmHg) Standard Deviation 9	-1 Millimetre 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 Analysed' = participants with available data.

Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=380 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=372 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=373 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Total Cholesterol	0.99 Ratio of total cholesterol Geometric Coefficient of Variation 17.9	0.97 Ratio of total cholesterol Geometric Coefficient of Variation 20.1	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 18.9

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=375 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=372 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=369 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in HDL Cholesterol	1.07 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.7	1.06 Ratio of HDL cholesterol Geometric Coefficient of Variation 16.0	1.04 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.3

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=380 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=372 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=373 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in LDL Cholesterol	1.00 Ratio of LDL cholesterol Geometric Coefficient of Variation 30.9	0.99 Ratio of LDL cholesterol Geometric Coefficient of Variation 37.5	1.00 Ratio of LDL cholesterol Geometric Coefficient of Variation 28.9

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=380 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=372 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=373 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in VLDL Cholesterol	0.80 Ratio of VLDL cholesterol Geometric Coefficient of Variation 42.0	0.82 Ratio of VLDL cholesterol Geometric Coefficient of Variation 42.1	0.92 Ratio of VLDL cholesterol Geometric Coefficient of Variation 40.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=361 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=353 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=354 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Free Fatty Acids	0.84 Ratio of free fatty acids Geometric Coefficient of Variation 68.7	0.85 Ratio of free fatty acids Geometric Coefficient of Variation 61.4	1.01 Ratio of free fatty acids Geometric Coefficient of Variation 62.3

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=380 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=372 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=373 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Triglycerides	0.79 Ratio of triglycerides Geometric Coefficient of Variation 43.8	0.81 Ratio of triglycerides Geometric Coefficient of Variation 44.5	0.92 Ratio of triglycerides Geometric Coefficient of Variation 44.5

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=380 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=372 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=373 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in hsCRP	0.50 Ratio of hsCRP Geometric Coefficient of Variation 125.7	0.59 Ratio of hsCRP Geometric Coefficient of Variation 115.7	0.84 Ratio of hsCRP Geometric Coefficient of Variation 90.9

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=353 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=334 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=336 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in PAI-1 Activity	1.06 Ratio of PAI-1 activity Geometric Coefficient of Variation 80.8	1.21 Ratio of PAI-1 activity Geometric Coefficient of Variation 73.7	1.42 Ratio of PAI-1 activity Geometric Coefficient of Variation 68.9

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = 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 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.

Outcome measures

Measure	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=370 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=365 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)	2.8 Score on a scale Standard Deviation 7.7	2.1 Score on a scale Standard Deviation 6.8	0.8 Score on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = 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 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.

Outcome measures

Measure	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=370 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=365 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in SF-36 (All Scores Except Physical Functioning) Role-Physical	0.8 Score on a scale Standard Deviation 7.4	0.6 Score on a scale Standard Deviation 6.9	0.0 Score on a scale Standard Deviation 7.1
Change in SF-36 (All Scores Except Physical Functioning) Bodily Pain	0.3 Score on a scale Standard Deviation 9.0	0.4 Score on a scale Standard Deviation 8.3	-0.4 Score on a scale Standard Deviation 8.6
Change in SF-36 (All Scores Except Physical Functioning) General Health	2.2 Score on a scale Standard Deviation 7.3	1.7 Score on a scale Standard Deviation 7.2	0.6 Score on a scale Standard Deviation 7.5
Change in SF-36 (All Scores Except Physical Functioning) Vitality	0.8 Score on a scale Standard Deviation 7.9	-0.1 Score on a scale Standard Deviation 7.8	-0.9 Score on a scale Standard Deviation 7.9
Change in SF-36 (All Scores Except Physical Functioning) Social Functioning	0.2 Score on a scale Standard Deviation 6.6	-0.3 Score on a scale Standard Deviation 6.6	-0.7 Score on a scale Standard Deviation 7.4
Change in SF-36 (All Scores Except Physical Functioning) Role-Emotional	-0.4 Score on a scale Standard Deviation 7.7	-0.4 Score on a scale Standard Deviation 7.3	-1.1 Score on a scale Standard Deviation 7.8
Change in SF-36 (All Scores Except Physical Functioning) Mental Health	-0.4 Score on a scale Standard Deviation 6.9	-0.9 Score on a scale Standard Deviation 7.5	-1.6 Score on a scale Standard Deviation 7.5
Change in SF-36 (All Scores Except Physical Functioning) Physical component summary	2.3 Score on a scale Standard Deviation 7.2	1.9 Score on a scale Standard Deviation 6.4	0.9 Score on a scale Standard Deviation 6.6
Change in SF-36 (All Scores Except Physical Functioning) Mental component summary	-0.9 Score on a scale Standard Deviation 6.9	-1.4 Score on a scale Standard Deviation 7.4	-1.8 Score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=369 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=365 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)	11.4 Score on a scale Standard Deviation 20.8	8.5 Score on a scale Standard Deviation 18.8	4.9 Score on a scale Standard Deviation 20.4

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

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

The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Outcome measures

Measure	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=369 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=365 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in IWQOL-Lite for CT (All Scores Except Physical Function) Physical	11.0 Score on a scale Standard Deviation 19.6	7.6 Score on a scale Standard Deviation 18.0	4.4 Score on a scale Standard Deviation 19.1
Change in IWQOL-Lite for CT (All Scores Except Physical Function) Psychosocial	9.6 Score on a scale Standard Deviation 16.7	8.6 Score on a scale Standard Deviation 15.7	5.6 Score on a scale Standard Deviation 16.5
Change in IWQOL-Lite for CT (All Scores Except Physical Function) Total	10.1 Score on a scale Standard Deviation 15.9	8.2 Score on a scale Standard Deviation 14.8	5.2 Score on a scale Standard Deviation 15.5

SECONDARY outcome

Timeframe: At week 68

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

The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers 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. Endpoint was evaluated based on 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	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=370 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=365 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score Yes (with threshold 4.3)	111 Participants	88 Participants	68 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score No (with threshold 4.3)	265 Participants	282 Participants	297 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score Yes (with threshold 3.7)	158 Participants	130 Participants	102 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score No (with threshold 3.7)	218 Participants	240 Participants	263 Participants

SECONDARY outcome

Timeframe: At week 68

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = 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 which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).

Outcome measures

Measure	Placebo n=376 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=369 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=365 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score Yes (with threshold 20)	131 Participants	107 Participants	83 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score No (with threshold 20)	245 Participants	262 Participants	282 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score Yes (with threshold 14.6)	160 Participants	144 Participants	113 Participants
Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score No (with threshold 14.6)	216 Participants	225 Participants	252 Participants

SECONDARY outcome

Timeframe: Week 0 to week 75

Population: Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.

Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.

Outcome measures

Measure	Placebo n=402 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=403 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Number of TEAEs - Semaglutide 2.4 mg Versus Placebo	1388 Events	2197 Events	—

SECONDARY outcome

Timeframe: Week 0 to week 75

Population: SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.

Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.

Outcome measures

Measure	Placebo n=402 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=403 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Number of SAEs - Semaglutide 2.4 mg Versus Placebo	53 Events	71 Events	—

SECONDARY outcome

Timeframe: Week 0 to week 75

Population: SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.

Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Placebo n=402 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=403 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo	18 Episodes	51 Episodes	—

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.

Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Outcome measures

Measure	Placebo n=340 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=351 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Pulse - Semaglutide 2.4 mg Versus Placebo	0 Beats/minute Standard Deviation 9	2 Beats/minute Standard Deviation 9	—

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.

Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Outcome measures

Measure	Placebo n=338 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=350 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Amylase - Semaglutide 2.4 mg Versus Placebo	1.06 Ratio of amylase Geometric Coefficient of Variation 25.0	1.24 Ratio of amylase Geometric Coefficient of Variation 28.3	—

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.

Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Outcome measures

Measure	Placebo n=338 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=350 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Lipase - Semaglutide 2.4 mg Versus Placebo	0.99 Ratio of lipase Geometric Coefficient of Variation 51.8	1.41 Ratio of lipase Geometric Coefficient of Variation 57.2	—

SECONDARY outcome

Timeframe: Baseline (week 0) to week 68

Population: SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.

Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Outcome measures

Measure	Placebo n=339 Participants Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=348 Participants Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo	0.96 Ratio of calcitonin Geometric Coefficient of Variation 38.6	0.94 Ratio of calcitonin Geometric Coefficient of Variation 60.3	—

Adverse Events

Semaglutide 1.0 mg

Serious events: 31 serious events

Other events: 261 other events

Deaths: 1 deaths

Semaglutide 2.4 mg

Serious events: 40 serious events

Other events: 284 other events

Deaths: 1 deaths

Placebo

Serious events: 37 serious events

Other events: 190 other events

Deaths: 1 deaths

Serious adverse events

Measure	Semaglutide 1.0 mg n=402 participants at risk Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=403 participants at risk Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=402 participants at risk Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Gastrointestinal disorders Abdominal pain	0.75% 3/402 • Number of events 3 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Renal and urinary disorders Acute kidney injury	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/403 • Number of events 3 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Acute myocardial infarction	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Angina pectoris	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Angina unstable	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Ankle fracture	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Vascular disorders Aortic rupture	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Appendicitis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Atrial fibrillation	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/403 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Renal and urinary disorders Bladder outlet obstruction	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Bradycardia	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Bronchitis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Cachexia	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Cardiac failure acute	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Cardiac failure congestive	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Surgical and medical procedures Cardiac pacemaker replacement	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Eye disorders Cataract	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Cellulitis	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Cerebral artery thrombosis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Cerebral infarction	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Cerebrovascular accident	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
General disorders Chest pain	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Hepatobiliary disorders Cholelithiasis	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Colonic abscess	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Cystitis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Decreased appetite	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Dehydration	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Diarrhoea	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Diverticular perforation	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Diverticulitis	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Empyema	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Fall	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Food poisoning	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer stage IV	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Gastric ulcer	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Gastritis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Gastroenteritis	0.75% 3/402 • Number of events 3 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.74% 3/403 • Number of events 3 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal lymphoma	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Eye disorders Glaucoma	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Hepatic encephalopathy	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Herpes zoster	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Hip fracture	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Hyperaesthesia	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Hyperglycaemia	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Vascular disorders Hypertension	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/403 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Vascular disorders Hypertensive urgency	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Hyponatraemic encephalopathy	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Immune system disorders Immunisation reaction	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Inguinal hernia	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Ischaemic stroke	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Joint abscess	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratinising squamous cell carcinoma of nasopharynx	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Kidney infection	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Lactic acidosis	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Ligament rupture	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Lisfranc fracture	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid leukaemia	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Myocardial infarction	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Myocardial ischaemia	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Nausea	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Obesity	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Osteomyelitis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Pharyngitis streptococcal	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Pneumonia	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Pneumonia influenzal	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Postoperative wound infection	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Presyncope	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Respiratory tract infection	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/403 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Sepsis	0.75% 3/402 • Number of events 3 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Vascular disorders Shock	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Surgical and medical procedures Sperm aspiration	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Spinal epidural haematoma	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Renal and urinary disorders Stag horn calculus	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Surgical and medical procedures Stent placement	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Cardiac disorders Supraventricular tachycardia	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Syncope	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Surgical and medical procedures Thyroidectomy	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Renal and urinary disorders Ureterolithiasis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/402 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Urosepsis	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Reproductive system and breast disorders Uterine polyp	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Viral infection	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/403 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Vomiting	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.50% 2/403 • Number of events 2 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Wound infection staphylococcal	0.00% 0/402 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.00% 0/403 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	0.25% 1/402 • Number of events 1 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).

Other adverse events

Measure	Semaglutide 1.0 mg n=402 participants at risk Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Semaglutide 2.4 mg n=403 participants at risk Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.	Placebo n=402 participants at risk Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.
Gastrointestinal disorders Abdominal distension	2.2% 9/402 • Number of events 12 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	6.0% 24/403 • Number of events 30 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	2.7% 11/402 • Number of events 13 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 24/402 • Number of events 27 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	5.7% 23/403 • Number of events 29 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	5.0% 20/402 • Number of events 20 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Musculoskeletal and connective tissue disorders Back pain	7.0% 28/402 • Number of events 30 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	6.7% 27/403 • Number of events 30 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	3.5% 14/402 • Number of events 15 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Constipation	12.7% 51/402 • Number of events 70 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	17.4% 70/403 • Number of events 82 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	5.5% 22/402 • Number of events 26 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Metabolism and nutrition disorders Decreased appetite	7.2% 29/402 • Number of events 33 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	9.4% 38/403 • Number of events 41 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	3.7% 15/402 • Number of events 17 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Diarrhoea	21.9% 88/402 • Number of events 157 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	21.3% 86/403 • Number of events 141 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	11.9% 48/402 • Number of events 66 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Dyspepsia	6.7% 27/402 • Number of events 27 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	6.2% 25/403 • Number of events 30 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	1.2% 5/402 • Number of events 5 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
General disorders Fatigue	4.7% 19/402 • Number of events 26 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	6.9% 28/403 • Number of events 29 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	1.00% 4/402 • Number of events 4 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Flatulence	5.2% 21/402 • Number of events 25 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	4.0% 16/403 • Number of events 21 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	1.7% 7/402 • Number of events 9 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Gastroenteritis	5.2% 21/402 • Number of events 25 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	2.7% 11/403 • Number of events 12 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	3.0% 12/402 • Number of events 14 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Nervous system disorders Headache	8.2% 33/402 • Number of events 48 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	7.7% 31/403 • Number of events 40 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	5.0% 20/402 • Number of events 27 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Nasopharyngitis	11.7% 47/402 • Number of events 69 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	16.9% 68/403 • Number of events 115 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	14.7% 59/402 • Number of events 92 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Nausea	31.8% 128/402 • Number of events 196 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	33.5% 135/403 • Number of events 248 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	9.2% 37/402 • Number of events 45 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Infections and infestations Upper respiratory tract infection	9.2% 37/402 • Number of events 54 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	10.4% 42/403 • Number of events 48 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	9.5% 38/402 • Number of events 50 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).
Gastrointestinal disorders Vomiting	13.4% 54/402 • Number of events 93 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	21.3% 86/403 • Number of events 186 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).	2.7% 11/402 • Number of events 12 • Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment. All presented AEs are treatment-emergent (i.e., TEAEs).

Additional Information

Clinical Transparency Anchor and Disclosure (1452)

Novo Nordisk A/S

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Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
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Restriction type: OTHER