NCT00532779

A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects

A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,742 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are 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 bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of 2 doses 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.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	Naltrexone SR 16 mg/Bupropion SR 360 mg /day
DRUG	Naltrexone SR 32 mg/Bupropion SR 360 mg /day
DRUG	Placebo
BEHAVIORAL	Ancillary therapy	Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-09-20
• Last updated: 2014-11-21
• Results posted: 2014-11-21

Locations

34 sites across 1 country: United States