Trial Outcomes & Findings for A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight (NCT NCT05649137)

NCT ID: NCT05649137

Last Updated: 2026-04-27

Results Overview

Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

512 participants

Primary outcome timeframe

Baseline (week 0), End of treatment (week 72)

Results posted on

2026-04-27

Participant Flow

The trial was conducted at 68 sites in 8 countries.

Participant milestones

Participant milestones
Measure	Semaglutide 7.2 mg Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.	Semaglutide 2.4 mg Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.
Overall Study STARTED	307	103	102
Overall Study Full Analysis Set	307	103	102
Overall Study Safety Analysis Set	307	103	102
Overall Study COMPLETED	295	100	96
Overall Study NOT COMPLETED	12	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Semaglutide 7.2 mg Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.	Semaglutide 2.4 mg Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.
Overall Study Withdrawal by Subject	5	0	3
Overall Study Lost to Follow-up	2	0	2
Overall Study Physician Decision	1	1	0
Overall Study Death	4	1	1
Overall Study Unspecified reason	0	1	0

Baseline Characteristics

A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide 7.2 mg n=307 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.	Semaglutide 2.4 mg n=103 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=102 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Total n=512 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	291 Participants n=226 Participants	98 Participants n=240 Participants	94 Participants n=236 Participants	483 Participants n=702 Participants
Age, Continuous	57 Years STANDARD_DEVIATION 10 • n=226 Participants	58 Years STANDARD_DEVIATION 10 • n=240 Participants	55 Years STANDARD_DEVIATION 10 • n=236 Participants	56 Years STANDARD_DEVIATION 10 • n=702 Participants
Sex: Female, Male Female	166 Participants n=226 Participants	47 Participants n=240 Participants	52 Participants n=236 Participants	265 Participants n=702 Participants
Sex: Female, Male Male	141 Participants n=226 Participants	56 Participants n=240 Participants	50 Participants n=236 Participants	247 Participants n=702 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=226 Participants	5 Participants n=240 Participants	8 Participants n=236 Participants	29 Participants n=702 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	0 Participants n=702 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	1 Participants n=702 Participants
Race (NIH/OMB) Asian	19 Participants n=226 Participants	7 Participants n=240 Participants	6 Participants n=236 Participants	32 Participants n=702 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	5 Participants n=702 Participants
Race (NIH/OMB) Black or African American	22 Participants n=226 Participants	13 Participants n=240 Participants	9 Participants n=236 Participants	44 Participants n=702 Participants
Race (NIH/OMB) White	258 Participants n=226 Participants	83 Participants n=240 Participants	87 Participants n=236 Participants	428 Participants n=702 Participants
Race (NIH/OMB) More than one race	2 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	2 Participants n=702 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants	0 Participants n=702 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Relative Change in Body Weight	-10.7 Percentage (%) change in body weight Standard Deviation 8.1	-4.0 Percentage (%) change in body weight Standard Deviation 6.2	-13.5 Percentage (%) change in body weight Standard Deviation 8.7

PRIMARY outcome

Timeframe: At week 72

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Number of participants who achieve body weight reduction \>=5% is presented. Yes defines participants who achieved body weight reduction \>= 5% and No defines participants who did not achieve body weight reduction \>=5%.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no) Yes	73 Participants	33 Participants	251 Participants
Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no) No	24 Participants	62 Participants	40 Participants

SECONDARY outcome

Timeframe: At week 72

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure

Number of participants who achieve body weight reduction \>=10% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 10% and No defines participants who did not achieve body weight reduction greater than or equal to 10%.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no) Yes	50 Participants	11 Participants	183 Participants
Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no) No	47 Participants	84 Participants	108 Participants

SECONDARY outcome

Timeframe: At week 72

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Number of participants who achieve body weight reduction \>=15% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 15% and No defines participants who did not achieve body weight reduction greater than or equal to 15%.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no) Yes	28 Participants	7 Participants	120 Participants
Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no) No	69 Participants	88 Participants	171 Participants

SECONDARY outcome

Timeframe: At week 72

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Number of participants who achieve body weight reduction \>=20% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 20% and No defines participants who did not achieve body weight reduction greater than or equal to 20%.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no) Yes	14 Participants	2 Participants	62 Participants
Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no) No	83 Participants	93 Participants	229 Participants

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Waist Circumference	-10.6 Centimeters (cm) Standard Deviation 8.4	-6.5 Centimeters (cm) Standard Deviation 10.6	-12.6 Centimeters (cm) Standard Deviation 10.5

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=96 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=94 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=288 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Glycated Haemoglobin (HbA1c)	-1.7 Percentage of HbA1c Standard Deviation 1.0	-0.3 Percentage of HbA1c Standard Deviation 1.3	-1.8 Percentage of HbA1c Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Body Weight	-11.4 Kilograms (kg) Standard Deviation 8.9	-4.6 Kilograms (kg) Standard Deviation 7.1	-14.9 Kilograms (kg) Standard Deviation 10.6

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Body Mass Index (BMI)	-4.1 kilograms per meter square (kg/m^2) Standard Deviation 3.3	-1.6 kilograms per meter square (kg/m^2) Standard Deviation 2.5	-5.3 kilograms per meter square (kg/m^2) Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Systolic Blood Pressure	-7 Millimeters of mercury (mmHg) Standard Deviation 15	-3 Millimeters of mercury (mmHg) Standard Deviation 13	-8 Millimeters of mercury (mmHg) Standard Deviation 13

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=97 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=291 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Diastolic Blood Pressure	-3 mmHg Standard Deviation 10	-3 mmHg Standard Deviation 9	-3 mmHg Standard Deviation 9

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=94 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=94 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=286 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline	0.96 Ratio of total cholesterol Geometric Coefficient of Variation 21.1	0.97 Ratio of total cholesterol Geometric Coefficient of Variation 28.3	0.96 Ratio of total cholesterol Geometric Coefficient of Variation 23.0

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=94 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=94 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=286 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline	0.96 Ratio of total cholesterol Geometric Coefficient of Variation 21.1	0.97 Ratio of total cholesterol Geometric Coefficient of Variation 28.3	0.96 Ratio of total cholesterol Geometric Coefficient of Variation 23.0

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=92 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=91 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=285 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline	1.06 Ratio of HDL cholesterol Geometric Coefficient of Variation 13.5	1.07 Ratio of HDL cholesterol Geometric Coefficient of Variation 16.1	1.10 Ratio of HDL cholesterol Geometric Coefficient of Variation 17.8

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=92 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=91 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=285 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in HDL Cholesterol (mg/dL) - Ratio to Baseline	1.06 Ratio of HDL cholesterol Geometric Coefficient of Variation 13.5	1.07 Ratio of HDL cholesterol Geometric Coefficient of Variation 16.1	1.10 Ratio of HDL cholesterol Geometric Coefficient of Variation 17.8

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=92 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=92 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=285 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline	0.95 Ratio of LDL cholesterol Geometric Coefficient of Variation 36.5	0.97 Ratio of LDL cholesterol Geometric Coefficient of Variation 41.4	0.99 Ratio of LDL cholesterol Geometric Coefficient of Variation 40.1

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=92 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=92 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=285 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in LDL Cholesterol (mg/dL) - Ratio to Baseline	0.95 Ratio of LDL cholesterol Geometric Coefficient of Variation 36.5	0.97 Ratio of LDL cholesterol Geometric Coefficient of Variation 41.4	0.99 Ratio of LDL cholesterol Geometric Coefficient of Variation 40.1

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=94 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=93 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=286 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline	0.81 Ratio of VLDL cholesterol Geometric Coefficient of Variation 40.4	0.90 Ratio of VLDL cholesterol Geometric Coefficient of Variation 47.8	0.72 Ratio of VLDL cholesterol Geometric Coefficient of Variation 42.5

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=94 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=93 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=286 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline	0.81 Ratio of VLDL cholesterol Geometric Coefficient of Variation 40.4	0.90 Ratio of VLDL cholesterol Geometric Coefficient of Variation 47.8	0.72 Ratio of VLDL cholesterol Geometric Coefficient of Variation 42.5

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=94 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=94 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=286 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Triglycerides (mmol/L) - Ratio to Baseline	0.80 Ratio of triglycerides Geometric Coefficient of Variation 42.2	0.87 Ratio of triglycerides Geometric Coefficient of Variation 54.4	0.71 Ratio of triglycerides Geometric Coefficient of Variation 46.2

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=94 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=94 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=286 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Triglycerides (mg/dL) - Ratio to Baseline	0.80 Ratio of triglycerides Geometric Coefficient of Variation 42.2	0.87 Ratio of triglycerides Geometric Coefficient of Variation 54.4	0.71 Ratio of triglycerides Geometric Coefficient of Variation 46.2

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in free fatty acids in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=93 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=92 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=284 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline	0.81 Ratio of free fatty acids Geometric Coefficient of Variation 70.6	0.98 Ratio of free fatty acids Geometric Coefficient of Variation 65.8	0.74 Ratio of free fatty acids Geometric Coefficient of Variation 69.8

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in free fatty acids in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=93 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=92 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=284 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline	0.81 Ratio of free fatty acids Geometric Coefficient of Variation 70.6	0.98 Ratio of free fatty acids Geometric Coefficient of Variation 65.8	0.74 Ratio of free fatty acids Geometric Coefficient of Variation 69.8

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in hsCRP in mg/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=95 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=95 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=286 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline	0.48 Ratio of hsCRP Geometric Coefficient of Variation 121.1	0.82 Ratio of hsCRP Geometric Coefficient of Variation 96.0	0.47 Ratio of hsCRP Geometric Coefficient of Variation 166.7

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=93 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=93 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=281 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Fasting Plasma Glucose	-58.4 mg/dL Standard Deviation 46.3	-20.2 mg/dL Standard Deviation 68.7	-59.6 mg/dL Standard Deviation 53.1

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=92 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=91 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=281 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline	0.90 Ratio of fasting serum insulin Geometric Coefficient of Variation 70.6	0.87 Ratio of fasting serum insulin Geometric Coefficient of Variation 71.4	0.77 Ratio of fasting serum insulin Geometric Coefficient of Variation 66.5

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=92 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=91 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=281 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline	0.90 Ratio of fasting serum insulin Geometric Coefficient of Variation 70.6	0.87 Ratio of fasting serum insulin Geometric Coefficient of Variation 71.4	0.77 Ratio of fasting serum insulin Geometric Coefficient of Variation 66.5

SECONDARY outcome

Timeframe: At week 72

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Number of participants with HbA1c less than 7.0 % (53 mmol/mol) at week 72 is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=96 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=94 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=288 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])	75 Participants	27 Participants	235 Participants

SECONDARY outcome

Timeframe: At week 72

Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Number of participants with HbA1c less than or equal to 6.5% (48 mmol/mol) at week 72 is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=96 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=94 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=288 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)	64 Participants	15 Participants	209 Participants

SECONDARY outcome

Timeframe: At week 81

Population: Safety analysis set included all participants who were exposed to at least one dose of randomised IMP.

Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=102 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=307 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)	253 Events	—	1581 Events

SECONDARY outcome

Timeframe: At week 81

Population: Safety analysis set included all participants who were exposed to at least one dose of randomised IMP.

Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=102 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=307 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)	21 Events	—	39 Events

SECONDARY outcome

Timeframe: Baseline (week 0), End of treatment (week 72)

Population: Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. Overall number of participants analyzed = Participants with available data for the outcome measure.

Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=92 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=84 Participants Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=271 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Change in Pulse	2 Beats per minute (bpm) Standard Deviation 10	-4 Beats per minute (bpm) Standard Deviation 9	1 Beats per minute (bpm) Standard Deviation 10

SECONDARY outcome

Timeframe: At week 81

Population: Safety analysis set included all participants who were exposed to at least one dose of randomised IMP.

Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=102 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=307 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Semaglutide 7.2 mg Versus Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes	1 Episodes	—	0 Episodes

SECONDARY outcome

Timeframe: At week 81

Population: Safety analysis set included all participants who were exposed to at least one dose of randomised IMP.

Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=103 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=307 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs	508 Events	—	1581 Events

SECONDARY outcome

Timeframe: At week 81

Population: Safety analysis set included all participants who were exposed to at least one dose of randomised IMP.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=103 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=307 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs	35 Events	—	39 Events

SECONDARY outcome

Timeframe: At week 81

Population: Safety analysis set included all participants who were exposed to at least one dose of randomised IMP.

Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes is presented.

Outcome measures

Outcome measures
Measure	Semaglutide 2.4 mg n=103 Participants Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	Semaglutide 7.2 mg n=307 Participants Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes	0 Episodes	—	0 Episodes

Adverse Events

Semaglutide 7.2 mg

Serious events: 30 serious events

Other events: 187 other events

Deaths: 4 deaths

Semaglutide 2.4 mg

Serious events: 11 serious events

Other events: 64 other events

Deaths: 1 deaths

Placebo

Serious events: 10 serious events

Other events: 40 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	Semaglutide 7.2 mg n=307 participants at risk Participants received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams \[mg\]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.	Semaglutide 2.4 mg n=103 participants at risk Participants received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7 and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.	Placebo n=102 participants at risk Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.
Gastrointestinal disorders Abdominal pain	5.2% 16/307 • Number of events 19 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	2.9% 3/103 • Number of events 4 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	2.9% 3/102 • Number of events 3 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 16/307 • Number of events 21 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	3.9% 4/103 • Number of events 4 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	3.9% 4/102 • Number of events 4 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Musculoskeletal and connective tissue disorders Back pain	5.5% 17/307 • Number of events 18 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	6.8% 7/103 • Number of events 8 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	2.9% 3/102 • Number of events 3 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Infections and infestations COVID-19	7.2% 22/307 • Number of events 22 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	4.9% 5/103 • Number of events 6 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	6.9% 7/102 • Number of events 7 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Eye disorders Cataract	2.9% 9/307 • Number of events 9 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	5.8% 6/103 • Number of events 7 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	3.9% 4/102 • Number of events 6 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Gastrointestinal disorders Constipation	14.7% 45/307 • Number of events 55 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	18.4% 19/103 • Number of events 21 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	4.9% 5/102 • Number of events 5 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Metabolism and nutrition disorders Decreased appetite	6.8% 21/307 • Number of events 25 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	7.8% 8/103 • Number of events 9 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	4.9% 5/102 • Number of events 6 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Gastrointestinal disorders Diarrhoea	18.2% 56/307 • Number of events 98 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	20.4% 21/103 • Number of events 35 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	8.8% 9/102 • Number of events 13 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Gastrointestinal disorders Dyspepsia	8.1% 25/307 • Number of events 36 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	3.9% 4/103 • Number of events 4 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	2.0% 2/102 • Number of events 2 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Gastrointestinal disorders Eructation	3.6% 11/307 • Number of events 13 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	7.8% 8/103 • Number of events 9 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	0.98% 1/102 • Number of events 1 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
General disorders Fatigue	6.8% 21/307 • Number of events 34 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	1.9% 2/103 • Number of events 3 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	4.9% 5/102 • Number of events 5 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Nervous system disorders Headache	7.2% 22/307 • Number of events 42 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	7.8% 8/103 • Number of events 11 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	3.9% 4/102 • Number of events 4 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Infections and infestations Nasopharyngitis	2.9% 9/307 • Number of events 10 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	2.9% 3/103 • Number of events 3 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	7.8% 8/102 • Number of events 9 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Gastrointestinal disorders Nausea	29.0% 89/307 • Number of events 206 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	28.2% 29/103 • Number of events 57 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	11.8% 12/102 • Number of events 18 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Skin and subcutaneous tissue disorders Sensitive skin	5.9% 18/307 • Number of events 24 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	1.9% 2/103 • Number of events 2 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	0.00% 0/102 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Infections and infestations Upper respiratory tract infection	5.5% 17/307 • Number of events 21 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	8.7% 9/103 • Number of events 9 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	4.9% 5/102 • Number of events 5 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
Gastrointestinal disorders Vomiting	16.6% 51/307 • Number of events 78 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	13.6% 14/103 • Number of events 39 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.	2.9% 3/102 • Number of events 4 • From week 0 to week 81 Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.