A Research Study to See How Semaglutide Helps People With... | NCT05649137

ID	Type	Description	Link
2022-002235-60	EudraCT Number
U1111-1279-0359	Other Identifier	World Health Organization (WHO)

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Semaglutide 7.2 mg	Experimental	Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.	Drug: Semaglutide
Semaglutide 2.4 mg	Experimental	Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.	Drug: Semaglutide
Placebo	Placebo Comparator	Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative Change in Body Weight	Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.	Baseline (week 0), End of treatment (week 72)
Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)	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%.	At week 72

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)	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%.	At week 72

Eligibility Module

Name	Affiliation	Role
Clinical Transparency (dept. 2834)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Univ of Alabama Birmingham		Birmingham	Alabama	35222	United States
Chambliss Clinical Trials, LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40961953	Derived	Lingvay I, Bergenheim SJ, Buse JB, Freitas P, Garvey WT, Harder-Lauridsen NM, Rosenstock J, Sahu K, Wharton S; STEP UP T2D trial group. Once-weekly semaglutide 7.2 mg in adults with obesity and type 2 diabetes (STEP UP T2D): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):935-948. doi: 10.1016/S2213-8587(25)00225-6. Epub 2025 Sep 14.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Semaglutide 2.4 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 22, 2023	Mar 26, 2026

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00057± 10 BG00158± 10 BG00255± 10 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000166 BG00147 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00016 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Relative Change in Body Weight

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

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

Posted

Mean

Standard Deviation

Percentage (%) change in body weight

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Units	Counts
Participants	OG000291 OG00197 OG00295

Title

Denominators

Categories

Title	Measurements
	OG000-13.5± 8.7 OG001-10.7± 8.1 OG002-4.0± 6.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		ANCOVA		<0.0001		Treatment difference	-9.33			2-Sided	95	-10.95	-7.71					Superiority

Primary

Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)

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%.

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

Posted

Count of Participants

Participants

At week 72

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)

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%.

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

Posted

Count of Participants

Participants

At week 72

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)

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%.

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

Posted

Count of Participants

Participants

At week 72

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)

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%.

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

Posted

Count of Participants

Participants

At week 72

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Waist Circumference

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

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

Posted

Mean

Standard Deviation

Centimeters (cm)

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Glycated Haemoglobin (HbA1c)

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

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

Posted

Mean

Standard Deviation

Percentage of HbA1c

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Body Weight

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

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

Posted

Mean

Standard Deviation

Kilograms (kg)

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Body Mass Index (BMI)

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

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

Posted

Mean

Standard Deviation

kilograms per meter square (kg/m^2)

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Systolic Blood Pressure

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

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

Posted

Mean

Standard Deviation

Millimeters of mercury (mmHg)

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Diastolic Blood Pressure

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

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

Posted

Mean

Standard Deviation

mmHg

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of total cholesterol

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of total cholesterol

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of HDL cholesterol

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in HDL Cholesterol (mg/dL) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of HDL cholesterol

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of LDL cholesterol

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in LDL Cholesterol (mg/dL) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of LDL cholesterol

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of VLDL cholesterol

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of VLDL cholesterol

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Triglycerides (mmol/L) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of triglycerides

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Triglycerides (mg/dL) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of triglycerides

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Free Fatty Acids (mmol/L) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of free fatty acids

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Free Fatty Acids (mg/dL) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of free fatty acids

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of hsCRP

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Fasting Plasma Glucose

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

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

Posted

Mean

Standard Deviation

mg/dL

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of fasting serum insulin

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of fasting serum insulin

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])

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

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

Posted

Count of Participants

Participants

At week 72

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)

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

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

Posted

Count of Participants

Participants

At week 72

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)

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.

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

Posted

Number

Events

At week 81

ID	Title	Description
OG000	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.
OG001	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Units	Counts
Participants	OG000

Secondary

Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)

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.

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

Posted

Number

Events

At week 81

ID	Title	Description
OG000	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.
OG001	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Units	Counts
Participants

Secondary

Change in Pulse

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

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.

Posted

Mean

Standard Deviation

Beats per minute (bpm)

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Secondary

Semaglutide 7.2 mg Versus Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

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

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

Posted

Number

Episodes

At week 81

ID	Title	Description
OG000	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.
OG001	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.

Units	Counts
Participants	OG000

Secondary

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs

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.

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

Posted

Number

Events

At week 81

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs

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

Posted

Number

Events

At week 81

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

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

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

Posted

Number

Episodes

At week 81

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	4	307	30	307	187	307
EG001	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.	1	103	11	103	64	103
EG002	Placebo	Participants received matching placebo to semaglutide s.c. once a week for 72 weeks.	1	102	10	102	40	102

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0021 events1 affected102 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Angina unstable	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Anginal equivalent	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Aortic aneurysm	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Arrhythmia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0012 events2 affected103 at risk EG0027 events3 affected102 at risk
Azotaemia	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Bell's palsy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Cardiac arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Cataract	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Coronary artery disease	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Erysipelas	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Gangrene	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Intervertebral disc injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Iridocyclitis	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Joint abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Liver injury	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Localised infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Macular oedema	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0012 events2 affected103 at risk EG0020 events0 affected102 at risk
Optic neuritis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0012 events1 affected103 at risk EG0020 events0 affected102 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Osteomyelitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Ovarian cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0011 events1 affected103 at risk EG0021 events1 affected102 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Renal colic	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk
Facial paralysis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Nodal rhythm	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Paraesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0010 events0 affected103 at risk EG0021 events1 affected102 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected307 at risk EG0010 events0 affected103 at risk EG0020 events0 affected102 at risk
Varicose vein	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected307 at risk EG0011 events1 affected103 at risk EG0020 events0 affected102 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00019 events16 affected307 at risk EG0014 events3 affected103 at risk EG0023 events3 affected102 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00021 events16 affected307 at risk EG0014 events4 affected103 at risk EG0024 events4 affected102 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00018 events17 affected307 at risk EG0018 events7 affected103 at risk EG0023 events3 affected102 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00022 events22 affected307 at risk EG0016 events5 affected103 at risk EG0027 events7 affected102 at risk
Cataract	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected307 at risk EG0017 events6 affected103 at risk EG0026 events4 affected102 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00055 events45 affected307 at risk EG00121 events19 affected103 at risk EG0025 events5 affected102 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00025 events21 affected307 at risk EG0019 events8 affected103 at risk EG0026 events5 affected102 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00098 events56 affected307 at risk EG00135 events21 affected103 at risk EG00213 events9 affected102 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00036 events25 affected307 at risk EG0014 events4 affected103 at risk EG0022 events2 affected102 at risk
Eructation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00013 events11 affected307 at risk EG0019 events8 affected103 at risk EG0021 events1 affected102 at risk
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG00034 events21 affected307 at risk EG0013 events2 affected103 at risk EG0025 events5 affected102 at risk
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00042 events22 affected307 at risk EG00111 events8 affected103 at risk EG0024 events4 affected102 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00010 events9 affected307 at risk EG0013 events3 affected103 at risk EG0029 events8 affected102 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000206 events89 affected307 at risk EG00157 events29 affected103 at risk EG00218 events12 affected102 at risk
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00024 events18 affected307 at risk EG0012 events2 affected103 at risk EG0020 events0 affected102 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00021 events17 affected307 at risk EG0019 events9 affected103 at risk EG0025 events5 affected102 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00078 events51 affected307 at risk EG00139 events14 affected103 at risk EG0024 events3 affected102 at risk

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D004700	Endocrine System Diseases