NCT00456521

A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 793 (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 a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.

Detailed description

The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg). Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study evaluated weight loss in subjects participating in such a comprehensive program who received a combination of naltrexone SR and bupropion SR, or placebo.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
DRUG	Placebo
BEHAVIORAL	Intensive group lifestyle modification counseling

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-04-05
• Last updated: 2014-12-17
• Results posted: 2014-11-21

Locations

9 sites across 1 country: United States