Obesity
Conditions
Brief summary
This study looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a dummy medicine that looks like the study medicine, but has no effect on the body. Participants will either get semaglutide or dummy medicine - which treatment participants get is decided by chance. 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. Participants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. The study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken. Participants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Interventions
Administered subcutaneously (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 44 weeks. Doses gradually increased to 2.4 mg
DRUGPlacebo (semaglutide 2.4 mg)
Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 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
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
* Age above or equal to 18 years at the time of signing informed consent. * BMI at least 25.0 kg/m\^2 at screening. * Both parents of Asian descent. * History of at least one self-reported unsuccessful dietary effort to lose body weight.
Exclusion criteria
* HbA1c at least 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 above 5 kg (11 lbs) within 90 days before screening irrespective of medical records. * Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety. * Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m\^2 at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (%) : In-trial Observation Period | Baseline (week 0), end of treatment (week 44) | Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Body Weight (%) : On-treatment Observation Period | Baseline (week 0), end of treatment (week 44) | Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses. |
| Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period | At week 44 | Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period | At week 44 | Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (kg) | Baseline (week 0), end of treatment (week 44) | Change in body weight in kilogram (kg) is presented from baseline (week 0) to the end of treatment (week 44) and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Body Mass Index | Baseline (week 0), end of treatment (week 44) | Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Systolic Blood Pressure (mmHg) | Baseline (week 0), end of treatment (week 44) | Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Diastolic Blood Pressure | Baseline (week 0), end of treatment (week 44) | Change in diastolic blood pressure from baseline (week 0) to end of the treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Total Cholesterol (mg/dL) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in total cholesterol in milligram per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Total Cholesterol (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in total cholesterol in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in HDL cholesterol in mg/dL from (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no) | At week 44 | Number of participants who achieved body weight reduction more than or equal to 10 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Triglycerides (mg/dL) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Triglycerides (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in hsCRP in milligram per liter (mg/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in HbA1c (%) | Baseline (week 0), end of treatment (week 44) | Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in HbA1c (mmol/Mol) | Baseline (week 0), end of treatment (week 44) | Change in glycosylated heamoglobin (HbA1c) in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no) | At week 44 | Number of participants who achieved body weight reduction more than or equal to 15 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no) | At week 44 | Number of participants who achieved body weight reduction more than or equal to 20 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
| Change in Waist Circumference | Baseline (week 0), end of treatment (week 44) | Change in waist circumference from baseline (week 0) to the end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). |
Countries
South Korea, Thailand
Participant flow
Recruitment details
The trial was conducted at 13 sites in Republic of Korea and Thailand.
Pre-assignment details
The trial included an initial 16 weeks of dose escalation period and a 28 weeks of maintenance period. 150 eligible participants were randomized in a 2:1 manner to receive either Semaglutide or placebo once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 101 |
| Placebo Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 49 |
| Total | 150 |
Baseline characteristics
| Characteristic | Semaglutide | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 41 Years STANDARD_DEVIATION 10 | 37 Years STANDARD_DEVIATION 11 | 39 Years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 49 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 101 Participants | 49 Participants | 150 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 78 Participants | 33 Participants | 111 Participants |
| Sex: Female, Male Male | 23 Participants | 16 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 49 |
| other Total, other adverse events | 80 / 101 | 34 / 49 |
| serious Total, serious adverse events | 13 / 101 | 4 / 49 |
Outcome results
Primary
Change in Body Weight (%) : In-trial Observation Period
Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Body Weight (%) : In-trial Observation Period | -16.4 Percentage of body weight | Standard Deviation 7.3 |
| Placebo | Change in Body Weight (%) : In-trial Observation Period | -2.6 Percentage of body weight | Standard Deviation 5.8 |
Comparison: Treatment policy Estimand. The primary endpoint was analysed using an analysis of covariance (ANCOVA) model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial observation period.p-value: <0.000195% CI: [-15.28, -10.7]ANCOVA
Primary
Change in Body Weight (%) : On-treatment Observation Period
Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Body Weight (%) : On-treatment Observation Period | -16.4 Percentage of body weight | Standard Deviation 7.4 |
| Placebo | Change in Body Weight (%) : On-treatment Observation Period | -2.7 Percentage of body weight | Standard Deviation 5.8 |
Comparison: Hypothetical Estimand. The primary endpoint was analysed using mixed model for repeated measurements (MMRM). All responses prior to first discontinuation of treatment (or dose reduction, or initiation of other anti-obesity medication or bariatric surgery) were included in MMRM with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.p-value: <0.000195% CI: [-15.7, -11.11]MMRM
Primary
Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period
Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: At week 44
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period | Yes | 96 Participants |
| Semaglutide | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period | No | 4 Participants |
| Placebo | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period | Yes | 12 Participants |
| Placebo | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period | No | 36 Participants |
Comparison: Treatment policy estimand. The primary endpoint was analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial period.p-value: <0.000195% CI: [21.96, 359.61]Regression, Logistic
Primary
Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period
Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.
Time frame: At week 44
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period | Yes | 92 Participants |
| Semaglutide | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period | No | 4 Participants |
| Placebo | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period | Yes | 12 Participants |
| Placebo | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period | No | 35 Participants |
Comparison: Hypothetical estimand. MMRM was used with randomized treatment as factor and baseline body weight as covariate. The MMRM was performed on body weight (kg) and individual missing week 44 responses were predicted from the MMRM, each participant was then classified for body weight loss \>= 5% and analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.p-value: <0.000195% CI: [38.41, 1672.57]Regression, Logistic
Secondary
Change in Body Mass Index
Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Body Mass Index | -4.9 Kilogram per square meter (kg/m^2) | Standard Deviation 2.1 |
| Placebo | Change in Body Mass Index | -0.8 Kilogram per square meter (kg/m^2) | Standard Deviation 1.9 |
Secondary
Change in Body Weight (kg)
Change in body weight in kilogram (kg) is presented from baseline (week 0) to the end of treatment (week 44) and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Body Weight (kg) | -13.0 Kg | Standard Deviation 5.5 |
| Placebo | Change in Body Weight (kg) | -2.0 Kg | Standard Deviation 5.1 |
Secondary
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to end of the treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Diastolic Blood Pressure | -4 MmHg | Standard Deviation 11 |
| Placebo | Change in Diastolic Blood Pressure | 0 MmHg | Standard Deviation 12 |
Secondary
Change in HbA1c (%)
Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in HbA1c (%) | -0.4 Percentage of HbA1c | Standard Deviation 0.3 |
| Placebo | Change in HbA1c (%) | 0.0 Percentage of HbA1c | Standard Deviation 0.2 |
Secondary
Change in HbA1c (mmol/Mol)
Change in glycosylated heamoglobin (HbA1c) in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in HbA1c (mmol/Mol) | -4.5 Mmol/mol | Standard Deviation 3.2 |
| Placebo | Change in HbA1c (mmol/Mol) | -0.1 Mmol/mol | Standard Deviation 2.3 |
Secondary
Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
Change in HDL cholesterol in mg/dL from (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.3 |
| Placebo | Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline | 1.04 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.7 |
Secondary
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.3 |
| Placebo | Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | 1.04 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.7 |
Secondary
Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline
Change in hsCRP in milligram per liter (mg/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline | 0.54 Ratio of hsCRP | Geometric Coefficient of Variation 170 |
| Placebo | Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline | 0.89 Ratio of hsCRP | Geometric Coefficient of Variation 73.7 |
Secondary
Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline
Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline | 0.93 Ratio of LDL cholesterol | Geometric Coefficient of Variation 25.6 |
| Placebo | Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline | 1.04 Ratio of LDL cholesterol | Geometric Coefficient of Variation 21.6 |
Secondary
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | 0.93 Ratio of LDL cholesterol | Geometric Coefficient of Variation 25.6 |
| Placebo | Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | 1.04 Ratio of LDL cholesterol | Geometric Coefficient of Variation 21.6 |
Secondary
Change in Systolic Blood Pressure (mmHg)
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Systolic Blood Pressure (mmHg) | -11 Millimeter of mercury (mmHg) | Standard Deviation 14 |
| Placebo | Change in Systolic Blood Pressure (mmHg) | -1 Millimeter of mercury (mmHg) | Standard Deviation 13 |
Secondary
Change in Total Cholesterol (mg/dL) - Ratio to Baseline
Change in total cholesterol in milligram per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Total Cholesterol (mg/dL) - Ratio to Baseline | 0.91 Ratio of total cholesterol | Geometric Coefficient of Variation 15.7 |
| Placebo | Change in Total Cholesterol (mg/dL) - Ratio to Baseline | 1.03 Ratio of total cholesterol | Geometric Coefficient of Variation 12.3 |
Secondary
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Change in total cholesterol in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Total Cholesterol (mmol/L) - Ratio to Baseline | 0.91 Ratio of total cholesterol | Geometric Coefficient of Variation 15.7 |
| Placebo | Change in Total Cholesterol (mmol/L) - Ratio to Baseline | 1.03 Ratio of total cholesterol | Geometric Coefficient of Variation 12.3 |
Secondary
Change in Triglycerides (mg/dL) - Ratio to Baseline
Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Triglycerides (mg/dL) - Ratio to Baseline | 0.72 Ratio of triglycerides | Geometric Coefficient of Variation 40.9 |
| Placebo | Change in Triglycerides (mg/dL) - Ratio to Baseline | 0.96 Ratio of triglycerides | Geometric Coefficient of Variation 42.1 |
Secondary
Change in Triglycerides (mmol/L) - Ratio to Baseline
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Triglycerides (mmol/L) - Ratio to Baseline | 0.72 Ratio of triglycerides | Geometric Coefficient of Variation 40.9 |
| Placebo | Change in Triglycerides (mmol/L) - Ratio to Baseline | 0.96 Ratio of triglycerides | Geometric Coefficient of Variation 42.1 |
Secondary
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to the end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: Baseline (week 0), end of treatment (week 44)
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Waist Circumference | -12.0 Centimeter (cm) | Standard Deviation 7.5 |
| Placebo | Change in Waist Circumference | -3.0 Centimeter (cm) | Standard Deviation 5.4 |
Secondary
Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)
Number of participants who achieved body weight reduction more than or equal to 10 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: At week 44
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no) | Yes | 78 Participants |
| Semaglutide | Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no) | No | 22 Participants |
| Placebo | Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no) | Yes | 5 Participants |
| Placebo | Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no) | No | 43 Participants |
Secondary
Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)
Number of participants who achieved body weight reduction more than or equal to 15 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: At week 44
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no) | Yes | 53 Participants |
| Semaglutide | Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no) | No | 47 Participants |
| Placebo | Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no) | Yes | 2 Participants |
| Placebo | Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no) | No | 46 Participants |
Secondary
Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)
Number of participants who achieved body weight reduction more than or equal to 20 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Time frame: At week 44
Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no) | Yes | 30 Participants |
| Semaglutide | Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no) | No | 70 Participants |
| Placebo | Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no) | Yes | 0 Participants |
| Placebo | Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no) | No | 48 Participants |