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
Measured in percentage (%).
Time frame: From baseline (week 0) to 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)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=25% (yes/no)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in waist circumference
Measured in centimeters (cm).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Relative change in body weight
Measured in percentage (%).
Time frame: From baseline (week 0) to 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)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=25% (yes/no)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in body weight
Measured in kilograms (kg).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)
Measured in kilogram per square meter (kg/m\^2).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in total fat mass (%)
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in total fat mass (liters)
Measured in liters.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in lean body mass (%)
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in lean body mass (liters)
Measured in liters.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (%)
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (liters)
Measured in liters.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure
Measured in millimeters of mercury (mmHg).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure
Measured in mmHg.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in total cholesterol
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in very low-density lipoprotein (VLDL) cholesterol
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in triglycerides
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in free fatty acids
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants with change in lipid-lowering treatment (decrease, no change, increase)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants with change in antihypertensive treatment (decrease, no change, increase)
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose
Measured in milligrams per deciliter (mg/dL).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants with change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D])
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg versus Placebo: Change in pulse
Measured in beats per minute (bmp).
Time frame: From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 81)
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