Conditions: Obesity Overweight
Keywords: Body Weight Bupropion Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Narcotic Antagonists Naltrexone Nutrition Disorders Obesity Overnutrition Overweight
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8910
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: NB32 intervention 2: PBO intervention 3: Weight Management Program
Intervention descriptions: intervention 1: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program. intervention 2: Placebo. Administered in addition to the weight management program. intervention 3: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.

Protocol document: