Obesity, Overweight
Conditions
Brief summary
This study will look at participants' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or dummy medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide dummy medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide dummy medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Interventions
DRUGSemaglutide
Dose gradually increased to 2.4 mg administered once weekly for 68 weeks
DRUGPlacebo (semaglutide)
Administered once weekly for 68 weeks
DRUGLiraglutide
Dose gradually increased to 3.0 mg administered once daily for 68 weeks
DRUGPlacebo (liraglutide)
Administered once daily for 68 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Semaglutide once weekly vs liraglutide once daily treatment will be open label, but each of the two active treatment arms will be double blinded against placebo administered at the same dosing frequency. Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age 18 years or older at the time of signing informed consent * Body mass index (BMI) equal to or above 30.0 kg/m\^2 or equal to or above 27.0 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
* HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes mellitus * A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg) | Baseline (week 0), week 68 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) | From baseline (week 0) to week 68 | 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. |
| Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) | From baseline (week 0) to week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Waist Circumference | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg)) | Baseline (week 0), week 68 | 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. |
| 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) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) | From baseline (week 0) to week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol)) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L) | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline | Baseline (week 0), week 68 | 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. |
| Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline | Baseline (week 0), week 68 | 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. |
| Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0), week 68 | 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. |
| Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product | From baseline (week 0) to week 68 | Number of participants who from baseline (week 0) to week 68 permanently discontinued randomized trial product are presented. |
| Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75 | 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. |
| Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75 | 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. |
| Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline) | Baseline (week 0), week 68 | 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. |
Countries
United States
Participant flow
Recruitment details
The trial was conducted at 19 sites in the United States (US).
Pre-assignment details
Total 338 adults with obesity (BMI greater than or equal to (\>=30.0) kilograms per square meter (kg/m\^2)) or overweight (BMI \>= 27.0 kg/m\^2) and at least one weight-related comorbidity were randomized in a 3:1:3:1 manner to receive treatment with either semaglutide subcutaneously (s.c.) 2.4 milligram (mg) once weekly or semaglutide placebo once weekly or liraglutide s.c. 3.0 mg once daily or liraglutide placebo once daily as an adjunct to a reduced-calorie diet and increased physical activity.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| 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 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 1 |
Baseline characteristics
| Characteristic | Semaglutide 2.4 mg | Liraglutide 3.0 mg | Pooled Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 48 Years STANDARD_DEVIATION 14 | 49 Years STANDARD_DEVIATION 13 | 51 Years STANDARD_DEVIATION 12 | 49 Years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 17 Participants | 7 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 111 Participants | 110 Participants | 78 Participants | 299 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants | 6 Participants | 3 Participants | 13 Participants |
| Race/Ethnicity, Customized Race Black or African American | 25 Participants | 20 Participants | 19 Participants | 64 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Race White | 94 Participants | 95 Participants | 60 Participants | 249 Participants |
| Sex: Female, Male Female | 102 Participants | 97 Participants | 66 Participants | 265 Participants |
| Sex: Female, Male Male | 24 Participants | 30 Participants | 19 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 127 | 0 / 85 |
| other Total, other adverse events | 115 / 126 | 115 / 127 | 68 / 85 |
| serious Total, serious adverse events | 10 / 126 | 14 / 127 | 6 / 85 |
Outcome results
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.
Time frame: Baseline (week 0), week 68
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg) | -16.4 Percentage of body weight | Standard Deviation 10.5 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg) | -6.4 Percentage of body weight | Standard Deviation 7.7 |
p-value: <0.000195% CI: [-11.97, -6.8]ANCOVA
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg)) | -15.8 kilograms | Standard Deviation 10.2 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg)) | -6.8 kilograms | Standard Deviation 9.5 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg)) | -1.4 kilograms | Standard Deviation 9.6 |
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)
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.
Time frame: Baseline (week 0), week 68
Population: The full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | 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) | -16.4 Percentage of body weight | Standard Deviation 10.5 |
| Liraglutide 3.0 mg | 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) | -6.4 Percentage of body weight | Standard Deviation 7.7 |
| Pooled Placebo | 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) | -1.6 Percentage of body weight | Standard Deviation 8.6 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure | -5 mmHg | Standard Deviation 9 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure | -1 mmHg | Standard Deviation 11 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure | 1 mmHg | Standard Deviation 9 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL) | -9.0 mg/dL | Standard Deviation 9.6 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL) | -4.9 mg/dL | Standard Deviation 10.4 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL) | 2.4 mg/dL | Standard Deviation 10.9 |
Secondary
Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L) | -0.5 mmol/L | Standard Deviation 0.5 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L) | -0.3 mmol/L | Standard Deviation 0.6 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L) | 0.1 mmol/L | Standard Deviation 0.6 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline | 0.73 Ratio of fasting serum insulin | Geometric Coefficient of Variation 57.3 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline | 0.85 Ratio of fasting serum insulin | Geometric Coefficient of Variation 47.5 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline | 0.98 Ratio of fasting serum insulin | Geometric Coefficient of Variation 56.8 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline | 0.73 Ratio of fasting serum insulin | Geometric Coefficient of Variation 57.3 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline | 0.85 Ratio of fasting serum insulin | Geometric Coefficient of Variation 47.5 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline | 0.98 Ratio of fasting serum insulin | Geometric Coefficient of Variation 56.8 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%) | -0.3 Percenatge of HbA1c | Standard Deviation 0.2 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%) | -0.1 Percenatge of HbA1c | Standard Deviation 0.3 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%) | 0.1 Percenatge of HbA1c | Standard Deviation 0.2 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol)) | -2.8 mmol/mol | Standard Deviation 2.6 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol)) | -1.0 mmol/mol | Standard Deviation 2.7 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol)) | 1.2 mmol/mol | Standard Deviation 2.5 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline | 0.46 Ratio of hs-CRP | Geometric Coefficient of Variation 154.1 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline | 0.73 Ratio of hs-CRP | Geometric Coefficient of Variation 93 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline | 0.78 Ratio of hs-CRP | Geometric Coefficient of Variation 71.5 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline) | 0.90 Ratio of FFA | Geometric Coefficient of Variation 81.5 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline) | 0.87 Ratio of FFA | Geometric Coefficient of Variation 77.7 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline) | 1.10 Ratio of FFA | Geometric Coefficient of Variation 77.2 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline) | 0.90 Ratio of FFA | Geometric Coefficient of Variation 81.5 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline) | 0.87 Ratio of FFA | Geometric Coefficient of Variation 77.7 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline) | 1.10 Ratio of FFA | Geometric Coefficient of Variation 77.2 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline) | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.7 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline) | 1.02 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.4 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline) | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.4 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline) | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.7 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline) | 1.02 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.4 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline) | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.4 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline) | 0.93 Ratio of LDL cholesterol | Geometric Coefficient of Variation 19.7 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline) | 1.01 Ratio of LDL cholesterol | Geometric Coefficient of Variation 23.4 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline) | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 26.3 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline) | 0.93 Ratio of LDL cholesterol | Geometric Coefficient of Variation 19.7 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline) | 1.01 Ratio of LDL cholesterol | Geometric Coefficient of Variation 23.4 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline) | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 26.3 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline) | 0.92 Ratio of total cholesterol | Geometric Coefficient of Variation 12.9 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline) | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 15 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline) | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 17.6 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline) | 0.92 Ratio of total cholesterol | Geometric Coefficient of Variation 12.9 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline) | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 15 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline) | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 17.6 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline) | 0.80 Ratio of triglycerides | Geometric Coefficient of Variation 33 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline) | 0.89 Ratio of triglycerides | Geometric Coefficient of Variation 36.7 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline) | 0.98 Ratio of triglycerides | Geometric Coefficient of Variation 35.7 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline) | 0.80 Ratio of triglycerides | Geometric Coefficient of Variation 33 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline) | 0.89 Ratio of triglycerides | Geometric Coefficient of Variation 36.7 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline) | 0.98 Ratio of triglycerides | Geometric Coefficient of Variation 35.7 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline) | 0.79 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 33.1 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline) | 0.89 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 36.9 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline) | 0.97 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 34.7 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline) | 0.79 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 33.1 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline) | 0.89 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 36.9 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline) | 0.97 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 34.7 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure | -7 millimeters of mercury (mmHg) | Standard Deviation 14 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure | -4 millimeters of mercury (mmHg) | Standard Deviation 15 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure | 5 millimeters of mercury (mmHg) | Standard Deviation 14 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 68 in Waist Circumference | -13.6 centimeters (cm) | Standard Deviation 10 |
| Liraglutide 3.0 mg | Change From Baseline (Week 0) to Week 68 in Waist Circumference | -6.8 centimeters (cm) | Standard Deviation 8.4 |
| Pooled Placebo | Change From Baseline (Week 0) to Week 68 in Waist Circumference | -2.0 centimeters (cm) | Standard Deviation 7.2 |
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.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): normo-glycaemia | 72 Participants |
| Semaglutide 2.4 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: pre-diabetes | 5 Participants |
| Semaglutide 2.4 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): pre-diabetes | 38 Participants |
| Semaglutide 2.4 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: normo-glycaemia | 104 Participants |
| Semaglutide 2.4 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: type 2 diabetes | 1 Participants |
| Semaglutide 2.4 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): type 2 diabetes | 0 Participants |
| Liraglutide 3.0 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: type 2 diabetes | 1 Participants |
| Liraglutide 3.0 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): normo-glycaemia | 74 Participants |
| Liraglutide 3.0 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): pre-diabetes | 37 Participants |
| Liraglutide 3.0 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): type 2 diabetes | 0 Participants |
| Liraglutide 3.0 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: normo-glycaemia | 89 Participants |
| Liraglutide 3.0 mg | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: pre-diabetes | 21 Participants |
| Pooled Placebo | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: normo-glycaemia | 38 Participants |
| Pooled Placebo | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: type 2 diabetes | 3 Participants |
| Pooled Placebo | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): normo-glycaemia | 47 Participants |
| Pooled Placebo | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Week 68: pre-diabetes | 36 Participants |
| Pooled Placebo | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): type 2 diabetes | 0 Participants |
| Pooled Placebo | Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D)) | Baseline (week 0): pre-diabetes | 30 Participants |
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.
Time frame: From baseline (week 0) to week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) | Yes | 65 Participants |
| Semaglutide 2.4 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) | No | 52 Participants |
| Liraglutide 3.0 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) | Yes | 14 Participants |
| Liraglutide 3.0 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) | No | 103 Participants |
| Pooled Placebo | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) | Yes | 5 Participants |
| Pooled Placebo | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no) | No | 73 Participants |
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.
Time frame: From baseline (week 0) to week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) | Yes | 45 Participants |
| Semaglutide 2.4 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) | No | 72 Participants |
| Liraglutide 3.0 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) | Yes | 7 Participants |
| Liraglutide 3.0 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) | No | 110 Participants |
| Pooled Placebo | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) | Yes | 2 Participants |
| Pooled Placebo | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no) | No | 76 Participants |
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.
Time frame: From baseline (week 0) to week 68
Population: FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) | Yes | 83 Participants |
| Semaglutide 2.4 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) | No | 34 Participants |
| Liraglutide 3.0 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) | Yes | 30 Participants |
| Liraglutide 3.0 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) | No | 87 Participants |
| Pooled Placebo | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) | Yes | 12 Participants |
| Pooled Placebo | Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no) | No | 66 Participants |
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.
Time frame: From baseline (week 0) to week 68
Population: FAS included all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product | 17 Participants |
| Liraglutide 3.0 mg | Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product | 35 Participants |
| Pooled Placebo | Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product | 15 Participants |
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.
Time frame: From baseline (week 0) to week 75
Population: SAS included all randomized participants exposed to at least one dose of randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75 | 14 Events |
| Liraglutide 3.0 mg | Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75 | 18 Events |
| Pooled Placebo | Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75 | 9 Events |
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.
Time frame: From baseline (week 0) to week 75
Population: The safety analysis set (SAS) included all randomized participants exposed to at least one dose of randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75 | 904 Events |
| Liraglutide 3.0 mg | Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75 | 823 Events |
| Pooled Placebo | Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75 | 522 Events |