This study will look at how much weight participants will lose and how much blood sugar control they achieve 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. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
512
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 will be 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 will be 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
John Muir Physicians Network
Concord, California, United States
Velocity Clinical Research Westlake
Los Angeles, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
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)
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% is presented. 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
Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)
Number of participants who achieve body weight reduction \>=10% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 10% and No defines participants who did not achieve body weight reduction greater than or equal to 10%.
Time frame: At week 72
Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)
Number of participants who achieve body weight reduction \>=15% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 15% and No defines participants who did not achieve body weight reduction greater than or equal to 15%.
Time frame: At week 72
Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)
Number of participants who achieve body weight reduction \>=20% is presented. Yes defines participants who achieved body weight reduction greater than or equal to 20% and No defines participants who did not achieve body weight reduction greater than or equal to 20%.
Time frame: At week 72
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)
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)
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)
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)
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)
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)
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) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline
Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
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) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in HDL Cholesterol (mg/dL) - Ratio to Baseline
Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
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) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in LDL Cholesterol (mg/dL) - Ratio to Baseline
Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
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) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline
Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Triglycerides (mmol/L) - Ratio to Baseline
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Triglycerides (mg/dL) - Ratio to Baseline
Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Change in free fatty acids in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Change in free fatty acids in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Change in hsCRP in mg/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
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)
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) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
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) as ratio to baseline is presented.
Time frame: Baseline (week 0), End of treatment (week 72)
Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])
Number of participants with HbA1c less than 7.0 % (53 mmol/mol) at week 72 is presented.
Time frame: At week 72
Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)
Number of participants with HbA1c less than or equal to 6.5% (48 mmol/mol) at week 72 is presented.
Time frame: At 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: At 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: At week 81
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 Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes is presented.
Time frame: At week 81
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: At 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: At week 81
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes is presented.
Time frame: At week 81
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