Obesity
Conditions
Brief summary
This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Interventions
Administered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg
DRUGPlacebo
Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged greater than or equal to 18 years at the time of signing informed consent. * BMI greater than or equal to 30.0 kg/m\^2 * Prediabetes defined as at least one of the following: * HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening. * FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.
Exclusion criteria
* History of type 1 or type 2 diabetes. * Treatment with glucose-lowering agent(s) within 90 days before screening. * HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening. * FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening. A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records. * Treatment with any medication for the indication of obesity within the past 90 days before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (Percentage [%]) | From randomisation (week 0) to end of treatment (week 52) | Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Participants With Change to Normoglycemia | At week 52 | Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (\<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (\<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (\<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (\<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | From randomisation (week 0) to end of treatment (week 52) | Change in glycosylated haemoglobin (HbA1c) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Fasting Plasma Glucose (FPG) | From randomisation (week 0) to end of treatment (week 52) | Change in fasting plasma glucose (FPG) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Waist Circumference | From randomisation (week 0) to end of treatment (week 52) | Change in waist circumference from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Systolic Blood Pressure | From randomisation (week 0) to end of treatment (week 52) | Change in systolic blood pressure from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Total Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline | From randomisation (week 0) to end of treatment (week 52) | Change in very low density lipoprotein (VLDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Body Weight (Kilogram [Kg]) | From randomisation (week 0) to week 52 | Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No) | At week 52 | Participants who achieved body weight reduction greater than or equal to 5% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No) | At week 52 | Participants who achieved body weight reduction greater than or equal to 10% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No) | At week 52 | Participants who achieved body weight reduction greater than or equal to 15% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No) | At week 52 | Participants who achieved body weight reduction greater than or equal to 20% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
| Change in Pulse | From randomisation (week 0) to end of treatment (week 52) | Change in pulse from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death. |
Countries
Canada, Denmark, Finland, Spain, United Kingdom
Contacts
STUDY_DIRECTORClinical Transparency (dept. 1452)
Novo Nordisk A/S
Participant flow
Recruitment details
The trial was conducted at 30 sites in 5 countries as follows: Canada (15 sites), Denmark (2 sites), Finland (2 sites), Spain (3 sites) and United Kingdom (8 sites).
Pre-assignment details
The trial has a Main phase and Extension phase. Main phase: a 52-week treatment period (16 weeks of dose escalation and 36 weeks of maintenance dose). Extension phase: a 28-week off-treatment extension phase after the main phase for assessment of body weight, glycaemic and cardiovascular parameters. Participants were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo as an adjunct to a reduced-calorie diet and increased physical activity.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 2.4 mg Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 138 |
| Placebo Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 69 |
| Total | 207 |
Baseline characteristics
| Characteristic | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53 Years STANDARD_DEVIATION 11 | 53 Years STANDARD_DEVIATION 11 | 53 Years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants | 68 Participants | 200 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 124 Participants | 59 Participants | 183 Participants |
| Sex: Female, Male Female | 100 Participants | 47 Participants | 147 Participants |
| Sex: Female, Male Male | 38 Participants | 22 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 138 | 0 / 69 |
| other Total, other adverse events | 93 / 138 | 30 / 69 |
| serious Total, serious adverse events | 12 / 138 | 6 / 69 |
Outcome results
Primary
Change in Body Weight (Percentage [%])
Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: Full analysis set (FAS) included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Weight (Percentage [%]) | -14.4 Percentage (%) of body weight | Standard Deviation 7.9 |
| Placebo | Change in Body Weight (Percentage [%]) | -2.7 Percentage (%) of body weight | Standard Deviation 4.3 |
Comparison: Treatment policy estimandp-value: <0.000195% CI: [-12.97, -9.42]ANCOVA
Primary
Participants With Change to Normoglycemia
Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (\<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (\<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (\<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (\<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.
Time frame: At week 52
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants With Change to Normoglycemia | Normoglycemia | 103 Participants |
| Semaglutide 2.4 mg | Participants With Change to Normoglycemia | Pre-diabetes | 23 Participants |
| Semaglutide 2.4 mg | Participants With Change to Normoglycemia | Type 2 diabetes | 1 Participants |
| Placebo | Participants With Change to Normoglycemia | Normoglycemia | 9 Participants |
| Placebo | Participants With Change to Normoglycemia | Pre-diabetes | 53 Participants |
| Placebo | Participants With Change to Normoglycemia | Type 2 diabetes | 2 Participants |
Comparison: Treatment policy estimandp-value: <0.000195% CI: [8.68, 45.21]Regression, Logistic
Secondary
Change in Body Weight (Kilogram [Kg])
Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to week 52
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Weight (Kilogram [Kg]) | -15.8 kilogram (Kg) | Standard Deviation 9.3 |
| Placebo | Change in Body Weight (Kilogram [Kg]) | -2.8 kilogram (Kg) | Standard Deviation 5 |
Secondary
Change in Fasting Plasma Glucose (FPG)
Change in fasting plasma glucose (FPG) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Plasma Glucose (FPG) | -0.8 millimoles per liter (mmol/L) | Standard Deviation 0.6 |
| Placebo | Change in Fasting Plasma Glucose (FPG) | -0.3 millimoles per liter (mmol/L) | Standard Deviation 0.7 |
Secondary
Change in Glycosylated Haemoglobin (HbA1c)
Change in glycosylated haemoglobin (HbA1c) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Glycosylated Haemoglobin (HbA1c) | -0.4 Percentage of HbA1c | Standard Deviation 0.3 |
| Placebo | Change in Glycosylated Haemoglobin (HbA1c) | 0.1 Percentage of HbA1c | Standard Deviation 0.2 |
Secondary
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | 1.02 Ratio of HDL cholesterol | Geometric Coefficient of Variation 12.4 |
| Placebo | Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 11.7 |
Secondary
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | 0.93 Ratio of LDL cholesterol | Geometric Coefficient of Variation 26.6 |
| Placebo | Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | 1.03 Ratio of LDL cholesterol | Geometric Coefficient of Variation 23.6 |
Secondary
Change in Pulse
Change in pulse from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Pulse | 2 beats per minute (bpm) | Standard Deviation 10 |
| Placebo | Change in Pulse | 0 beats per minute (bpm) | Standard Deviation 7 |
Secondary
Change in Systolic Blood Pressure
Change in systolic blood pressure from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Systolic Blood Pressure | -9 millimeters of mercury (mmHg) | Standard Deviation 13 |
| Placebo | Change in Systolic Blood Pressure | -1 millimeters of mercury (mmHg) | Standard Deviation 13 |
Secondary
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Total Cholesterol (mmol/L) - Ratio to Baseline | 0.94 Ratio of total cholesterol | Geometric Coefficient of Variation 16.1 |
| Placebo | Change in Total Cholesterol (mmol/L) - Ratio to Baseline | 1.01 Ratio of total cholesterol | Geometric Coefficient of Variation 15.7 |
Secondary
Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline | 0.80 Ratio of triglycerides | Geometric Coefficient of Variation 36.4 |
| Placebo | Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline | 0.96 Ratio of triglycerides | Geometric Coefficient of Variation 30.6 |
Secondary
Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in very low density lipoprotein (VLDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline | 0.80 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 36.5 |
| Placebo | Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline | 0.96 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 30.7 |
Secondary
Change in Waist Circumference
Change in waist circumference from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: From randomisation (week 0) to end of treatment (week 52)
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Waist Circumference | -11.6 centimeter (cm) | Standard Deviation 8.7 |
| Placebo | Change in Waist Circumference | -2.8 centimeter (cm) | Standard Deviation 5.4 |
Secondary
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)
Participants who achieved body weight reduction greater than or equal to 10% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: At week 52
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No) | Yes | 95 Participants |
| Semaglutide 2.4 mg | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No) | No | 34 Participants |
| Placebo | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No) | Yes | 5 Participants |
| Placebo | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No) | No | 61 Participants |
Secondary
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)
Participants who achieved body weight reduction greater than or equal to 15% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: At week 52
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No) | Yes | 62 Participants |
| Semaglutide 2.4 mg | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No) | No | 67 Participants |
| Placebo | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No) | Yes | 1 Participants |
| Placebo | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No) | No | 65 Participants |
Secondary
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)
Participants who achieved body weight reduction greater than or equal to 20% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: At week 52
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No) | Yes | 32 Participants |
| Semaglutide 2.4 mg | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No) | No | 97 Participants |
| Placebo | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No) | Yes | 0 Participants |
| Placebo | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No) | No | 66 Participants |
Secondary
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)
Participants who achieved body weight reduction greater than or equal to 5% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Time frame: At week 52
Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No) | Yes | 111 Participants |
| Semaglutide 2.4 mg | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No) | No | 18 Participants |
| Placebo | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No) | Yes | 17 Participants |
| Placebo | Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No) | No | 49 Participants |