Research Study to Investigate How Well Semaglutide Works... | NCT04074161

ID	Type	Description	Link
U1111-1233-0977	Other Identifier	World Health Organization (WHO)

Label	Type	Description	Intervention Names
Semaglutide	Experimental	Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity	Drug: Semaglutide
Placebo (semaglutide)	Placebo Comparator	Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity	Drug: Placebo (semaglutide)
Liraglutide	Active Comparator	Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity	Drug: Liraglutide
Placebo (liraglutide)	Placebo Comparator	Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity	Drug: Placebo (liraglutide)

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	Dose gradually increased to 2.4 mg administered once weekly for 68 weeks	Semaglutide

Measure	Description	Time Frame
Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)	Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.	Baseline (week 0), week 68

Measure	Description	Time Frame
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)	Number of participants who achieved >= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

Name	Affiliation	Role
Clinical Reporting Anchor and Disclosure (1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Birmingham	Alabama	35294	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
34775881	Result	Wharton S, Davies M, Dicker D, Lingvay I, Mosenzon O, Rubino DM, Pedersen SD. Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice. Postgrad Med. 2022 Jan;134(1):14-19. doi: 10.1080/00325481.2021.2002616. Epub 2021 Nov 29.
35015037	Result	Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sorrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):138-150. doi: 10.1001/jama.2021.23619.

ID	Title	Description
FG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 25, 2020	Mar 21, 2022

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

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)

Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

The full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. It was planned to report data only for arms 'semaglutide 2.4 mg and liraglutide 3.0 mg' for this outcome measure.

Posted

Mean

Standard Deviation

Percentage of body weight

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Units	Counts
Participants	OG000117 OG001117

Title

Denominators

Categories

Title	Measurements
	OG000-16.4± 10.5 OG001-6.4± 7.7

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 OG001		ANCOVA		<0.0001		Treatment difference	-9.38			2-Sided	95	-11.97	-6.80					Superiority	Responses were analysed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.

Secondary

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)

Number of participants who achieved >= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

From baseline (week 0) to week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)

Number of participants who achieved >= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 15% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

From baseline (week 0) to week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)

Number of participants who achieved >= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 20% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

From baseline (week 0) to week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Waist Circumference

Change from baseline (week 0) to week 68 in waist circumference is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

centimeters (cm)

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))

Change from baseline (week 0) to week 68 in body weight is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

kilograms

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)

The full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Percentage of body weight

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure

Change from baseline (week 0) to week 68 in systolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure

Change from baseline (week 0) to week 68 in diastolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mmHg

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in total cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of total cholesterol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of total cholesterol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of HDL cholesterol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of HDL cholesterol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of LDL cholesterol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of LDL cholesterol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of VLDL cholesterol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of VLDL cholesterol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in FFA (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of FFA

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in FFA (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of FFA

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in triglycerides (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of triglycerides

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in triglycerides (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of triglycerides

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline

Change from baseline (week 0) to week 68 in hs-CRP (measured in mg/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of hs-CRP

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)

Change from baseline (week 0) to week 68 in HbA1c (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Percenatge of HbA1c

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))

Change from baseline (week 0) to week 68 in HbA1c is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mmol/mol

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)

Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mg/dL

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mmol/L

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline

Change from baseline (week 0) to week 68 in fasting serum insulin (measured in mIU/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of fasting serum insulin

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline

Change from baseline (week 0) to week 68 in fasting serum insulin (measured in pmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of fasting serum insulin

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))

Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and 68 are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: fasting plasma glucose (FPG) less than (<) 5.6 mmol/L (<100 mg/dL) and/or glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: FPG 5.6 - 6.9 mmol/L (both inclusive), FPG 100 - 125 mg/dL (both inclusive) or HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: FPG greater than or equal to (>=) 7.0 mmol/L (>=126 mg/dL) and/or HbA1c >=6.5%. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

Baseline (week 0), week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product

Number of participants who from baseline (week 0) to week 68 permanently discontinued randomized trial product are presented.

FAS included all randomized participants.

Posted

Count of Participants

Participants

From baseline (week 0) to week 68

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs mentioned here are TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.

The safety analysis set (SAS) included all randomized participants exposed to at least one dose of randomized treatment.

Posted

Number

Events

From baseline (week 0) to week 75

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.

Secondary

Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75

An AE was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as an AE that results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. SAEs occurred based on the on-treatment period is presented. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.

SAS included all randomized participants exposed to at least one dose of randomized treatment.

Posted

Number

Events

From baseline (week 0) to week 75

ID	Title	Description
OG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
OG001	Liraglutide 3.0 mg

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	126	10	126	115	126
EG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	127	14	127	115	127
EG002	Pooled Placebo	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.	85	6	85	68	85

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute kidney injury	Renal and urinary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Aortic stenosis	Vascular disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Atrial flutter	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0010 events0 affected127 at risk EG0021 events1 affected85 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0010 events0 affected127 at risk EG0021 events1 affected85 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0010 events0 affected127 at risk EG0021 events1 affected85 at risk
Chest discomfort	General disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Cholecystitis infective	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0011 events1 affected127 at risk EG0021 events1 affected85 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Influenza	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0011 events1 affected127 at risk EG0021 events1 affected85 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0010 events0 affected127 at risk EG0021 events1 affected85 at risk
Major depression	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Non-cardiac chest pain	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0010 events0 affected127 at risk EG0021 events1 affected85 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Osteomyelitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Post procedural drainage	Surgical and medical procedures	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0010 events0 affected127 at risk EG0021 events1 affected85 at risk
Sepsis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0010 events0 affected127 at risk EG0021 events1 affected85 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Uterine enlargement	Reproductive system and breast disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected127 at risk EG0020 events0 affected85 at risk
Viral sepsis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected127 at risk EG0020 events0 affected85 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0009 events7 affected126 at risk EG00110 events9 affected127 at risk EG0028 events7 affected85 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0008 events8 affected126 at risk EG0015 events5 affected127 at risk EG0021 events1 affected85 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0008 events8 affected126 at risk EG00115 events14 affected127 at risk EG0027 events7 affected85 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0006 events6 affected126 at risk EG00110 events9 affected127 at risk EG00210 events9 affected85 at risk
Bronchitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0006 events5 affected126 at risk EG0016 events5 affected127 at risk EG0025 events5 affected85 at risk
COVID-19	Infections and infestations	MedDRA 23	Systematic Assessment	EG0005 events5 affected126 at risk EG00111 events11 affected127 at risk EG0026 events5 affected85 at risk
Constipation	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00080 events49 affected126 at risk EG00152 events40 affected127 at risk EG00224 events20 affected85 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0008 events7 affected126 at risk EG0015 events4 affected127 at risk EG0025 events5 affected85 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG00015 events15 affected126 at risk EG00118 events16 affected127 at risk EG0023 events3 affected85 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00051 events35 affected126 at risk EG00137 events23 affected127 at risk EG00226 events22 affected85 at risk
Dizziness	Nervous system disorders	MedDRA 23	Systematic Assessment	EG00011 events10 affected126 at risk EG0018 events7 affected127 at risk EG0024 events4 affected85 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0007 events7 affected126 at risk EG0017 events6 affected127 at risk EG0026 events5 affected85 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00014 events11 affected126 at risk EG00116 events15 affected127 at risk EG0027 events5 affected85 at risk
Eructation	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00020 events17 affected126 at risk EG0015 events5 affected127 at risk EG0024 events4 affected85 at risk
Fatigue	General disorders	MedDRA 23	Systematic Assessment	EG00012 events12 affected126 at risk EG00117 events14 affected127 at risk EG0024 events4 affected85 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00013 events10 affected126 at risk EG0014 events4 affected127 at risk EG0026 events6 affected85 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00014 events12 affected126 at risk EG00113 events11 affected127 at risk EG0025 events5 affected85 at risk
Headache	Nervous system disorders	MedDRA 23	Systematic Assessment	EG00046 events20 affected126 at risk EG00120 events18 affected127 at risk EG00212 events10 affected85 at risk
Hypertension	Vascular disorders	MedDRA 23	Systematic Assessment	EG0008 events8 affected126 at risk EG0013 events3 affected127 at risk EG0022 events2 affected85 at risk
Influenza	Infections and infestations	MedDRA 23	Systematic Assessment	EG0004 events4 affected126 at risk EG00114 events14 affected127 at risk EG0026 events6 affected85 at risk
Insomnia	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG0003 events3 affected126 at risk EG0017 events7 affected127 at risk EG0022 events2 affected85 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG00010 events10 affected126 at risk EG00113 events11 affected127 at risk EG00211 events9 affected85 at risk
Nausea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG000130 events77 affected126 at risk EG001102 events75 affected127 at risk EG00224 events19 affected85 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG0003 events3 affected126 at risk EG0012 events2 affected127 at risk EG0026 events5 affected85 at risk
Seasonal allergy	Immune system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected126 at risk EG00110 events5 affected127 at risk EG0026 events5 affected85 at risk
Sinusitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0009 events8 affected126 at risk EG0018 events8 affected127 at risk EG00214 events13 affected85 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG00011 events9 affected126 at risk EG00126 events19 affected127 at risk EG00223 events18 affected85 at risk
Urinary tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG00010 events7 affected126 at risk EG0015 events5 affected127 at risk EG0022 events2 affected85 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00050 events32 affected126 at risk EG00134 events26 affected127 at risk EG0026 events5 affected85 at risk

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description
BG000	Semaglutide 2.4 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
BG001	Liraglutide 3.0 mg	The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
BG002	Pooled Placebo	Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.
BG003	Total	Total of all reporting groups