Phase 3Completed
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects
A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects
- Sponsor
- Orexigen Therapeutics, Inc (Industry)
- Enrolment
- 1,496 enrolled
- Conditions
- Obesity; Overweight
- Interventions
- Naltrexone SR 32 mg/bupropion SR 360 mg/day; Placebo; Ancillary therapy
- Ages
- adults, older adults
- Registry
- NCT00567255
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28
- Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28
History
Results first posted
Last registry update
Primary completion
Started
Registered