This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,407
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Chambliss Clinical Trials, LLC
Montgomery, Alabama, United States
Healthscan Clinical Trials,LLC.
Montgomery, Alabama, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Number of participants who achieve body weight reduction \>=5% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=5% and "no" defines participants who did not achieve body weight reduction \>=5%.
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no)
Number of participants who achieve body weight reduction \>=10% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=10% and "no" defines participants who did not achieve body weight reduction \>=10%.
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no)
Number of participants who achieve body weight reduction \>=15% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=15% and "no" defines participants who did not achieve body weight reduction \>=15%.
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
Number of participants who achieve body weight reduction \>=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=20% and "no" defines participants who did not achieve body weight reduction \>=20%.
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
Number of participants who achieve body weight reduction \>=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=25% and "no" defines participants who did not achieve body weight reduction \>=25%.
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference
Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
Number of participants who achieve body weight reduction \>=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=20% and "no" defines participants who did not achieve body weight reduction \>=20%.
Time frame: At week 72
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
Number of participants who achieve body weight reduction \>=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=25% and "no" defines participants who did not achieve body weight reduction \>=25%.
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Body Weight
Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight
Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%)
Change in total fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters)
Change in total fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%)
Change in lean body volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters)
Change in lean body volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%)
Change in visceral fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters)
Change in visceral fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Body Weight (%)
Change in body weight (%) from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg)
Change in body weight (Kg) from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline
Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: 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 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline
Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline
Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline
Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Change in hsCRP (milligram per liter \[mg/L\]) from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)
Number of participants with change in lipid-lowering treatment from baseline (week 0) is presented in categories as decrease, no change and increase.
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)
Number of participants with change in antihypertensive treatment from baseline (week 0) is presented in categories as decrease, no change and increase.
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c)
Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose
Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Number of participants with change in glycaemic category from baseline (week 0) to the end of treatment (week 72) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) \<5.7%; 2) Pre-diabetes: 5.7% \<= HbA1c \< 6.5%
Time frame: Baseline (week 0), end of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Time frame: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)
Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
Time frame: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg Versus Placebo: Change in Pulse
Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs
Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.
Time frame: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs
Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
Time frame: From baseline (week 0) to end of study (week 81)
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