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

> **NCT00456521** · PHASE3 · COMPLETED · sponsor: **Orexigen Therapeutics, Inc** · enrollment: 793 (actual)

## Conditions studied

- Obesity
- Overweight

## Interventions

- **DRUG:** Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
- **DRUG:** Placebo
- **BEHAVIORAL:** Intensive group lifestyle modification counseling

## Key facts

- **NCT ID:** NCT00456521
- **Lead sponsor:** Orexigen Therapeutics, Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-03
- **Primary completion:** 2008-12
- **Final completion:** 2008-12
- **Target enrollment:** 793 (ACTUAL)
- **Last updated:** 2014-12-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00456521

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-08-17 from https://api.ai-analytics.org/clinical/NCT00456521. Licensed CC0.

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