Conditions: Obesity Overweight
Keywords: Obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1496
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity.

Detailed description:
Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than naltrexone alone, bupropion SR alone or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.

Arms:
arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day with ancillary therapy arm 2: Placebo with ancillary therapy

Interventions: intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day intervention 2: Placebo intervention 3: Ancillary therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Protocol document: