This study will be conducted to demonstrate weight loss efficacy by change in body mass index (BMI) and safety in adolescents age 12 to 17 years (inclusive) during 52 weeks of treatment with Belviq XR 20 milligrams (mg) administered once daily (QD) as compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
278
oral tablet
oral tablet
Phoenix Clinical LLC
Phoenix, Arizona, United States
Alliance Research Institute
Bell Gardens, California, United States
Change in Body Mass Index (BMI) From Baseline up to Week 52
BMI is a participant's weight in kilograms divided by the square of height in meters. Change from baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline up to Week 52
Percentage of Participants Who Achieved at Least a 5 Percent (%) BMI Reduction at Week 52
Time frame: Baseline up to Week 52
Percentage of Participants Who Achieved at Least a 5% BMI Reduction at Week 12
Time frame: Baseline up to Week 12
Percentage of Participants Who Achieved at Least a 10% BMI Reduction at Week 52
Time frame: Baseline up to Week 52
Percent Change in BMI From Baseline up to Week 52
Time frame: Baseline up to Week 52
Change in BMI From Baseline up to Week 52 in Participants Who Also Had the Outcome of Achieving at Least a 5% BMI Reduction at Week 12
Time frame: Baseline up to Week 52
Percent Change in BMI From Baseline up to Week 52 in Participants Who Also Had the Outcome of Achieving at Least a 5% BMI Reduction at Week 12
Time frame: Baseline up to Week 52
Number of Participants Who Achieved at Least a 5% or 10% BMI Reduction up to Week 52 Who Also Achieved at Least a 5% BMI Reduction at Week 12
Time frame: Baseline up to Week 52
Change in Waist Circumference From Baseline up to Week 52
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Long Beach Clinical Trial Services, Inc
Long Beach, California, United States
International Research Partners LLC
Doral, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Gwinnett Research Institute
Buford, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Buynak Clinical Research, PC
Valparaiso, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
The Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States
...and 6 more locations
Time frame: Baseline up to Week 52
Change in Total Body Fat Mass From Baseline up to Week 52 Using Dual-energy X-ray Absorptiometry (DEXA)
DEXA is used to assess changes in body composition, including total fat and lean body mass and appendicular skeletal fat and muscle mass. DEXA instruments has a source that generates x-rays split into two energies which measures bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) are estimated.
Time frame: Baseline up to Week 52
Change in Total Body Lean Mass From Baseline up to Week 52 Using DEXA
DEXA is used to assess changes in body composition, including total fat and lean body mass and appendicular skeletal fat and muscle mass. DEXA instruments has a source that generates x-rays split into two energies which measures bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) are estimated.
Time frame: Baseline up to Week 52
Percent Change in Hemoglobin A1c (HbA1c) From Baseline up to Week 52 in Participants With Type 2 Diabetes Mellitus at Baseline
Percent change in HbA1c was analyzed for participants with Type 2 diabetes mellitus at baseline. Percent change from baseline was calculated as: \[post-baseline value minus the baseline value\]/baseline value)\*100.
Time frame: Baseline up to Week 52
Change in Fasting Plasma Glucose From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline
Change in fasting glucose was analyzed for participants with Type 2 diabetes mellitus at baseline. Change from baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline up to Week 52
Change in Fasting Insulin From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline
Change in fasting insulin was analyzed for participants with Type 2 diabetes mellitus at baseline. Change from baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline up to Week 52
Change in Homeostatic Model Assessment-insulin Resistance (HOMA-IR) From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline
HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR=fasting plasma insulin (micro international units per milliliter \[µIU/mL\]\*fasting plasma glucose (mmol/L)/22.5. A higher number indicates a greater insulin resistance.
Time frame: Baseline up to Week 52
Change in Fasting Plasma Glucose From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline
Time frame: Baseline up to Week 52
Change in Fasting Insulin From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline
Time frame: Baseline up to Week 52
Change in HOMA-IR From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline
HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR=fasting plasma insulin (µIU/mL\*fasting plasma glucose (mmol/L)/22.5. A higher number indicates a greater insulin resistance.
Time frame: Baseline up to Week 52
Change in Blood Pressure (Systolic and Diastolic) From Baseline up to Week 52
Systolic blood pressure is the maximum arterial pressure during contraction of the ventricles of the heart. Diastolic blood pressure is the minimum arterial pressure during relaxation and dilatation of the ventricles of the heart when the ventricles fill with blood.
Time frame: Baseline up to Week 52
Change in Heart Rate From Baseline up to Week 52
Heart rate is the number of heart beats per unit of time, usually per minute.
Time frame: Baseline up to Week 52
Change in Fasting Lipid Profile (Total Cholesterol, Low-density Lipoprotein [LDL] Cholesterol, High-density Lipoprotein [HDL] Cholesterol, Triglycerides) From Baseline up to Week 52
Total Cholesterol is a measure of the total amount of cholesterol in blood. It includes both LDL cholesterol and HDL cholesterol. LDL cholesterol is often called the "bad" cholesterol because it collects in the walls of blood vessels, raising chances of health problems like a heart attack or stroke. HDL cholesterol is known as the "good" cholesterol because it helps remove other forms of cholesterol from bloodstream. Triglycerides are the most common type of fat in the body.
Time frame: Baseline up to Week 52
Percentage of Participants With Prehypertension or Primary Hypertension at Week 52
Hypertension is defined as abnormally high blood pressure.
Time frame: Week 52
Percentage of Participants With Dyslipidemia at Week 52
Dyslipidemia is defined as abnormally high cholesterol.
Time frame: Week 52
Percentage of Participants by Study Drug Compliance Category During 52 Weeks of Treatment
Treatment compliance is defined as: (Total number of tablets dispensed minus total number of tablets lost or returned)/total number of tablets participant should have taken during the actual treatment. Compliance to study drug was categorized as less than (\<) 80%, 80% to 100%, greater than (\>) 100% to less than equal to (\<=) 120%, and \>120%.
Time frame: Up to Week 52