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NCT00456521 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Orexigen Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 793
- Enrollment target
NCT00456521: Completed Phase 3 study, sponsored by Orexigen Therapeutics.
NCT00456521 is a Phase 3 study that has completed, run by Orexigen Therapeutics. The registered enrollment target is 793 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00456521, a Phase 3 study, has completed, sponsored by Orexigen Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 793 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
- BEHAVIORAL Intensive group lifestyle modification counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00456521 record still lists
NCT00456521 is an interventional study that assigns participants to a tested intervention. The registered 793 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00456521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00456521 about?
NCT00456521 is a clinical study titled "A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program". 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.
What is the current status of trial NCT00456521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 793 participants. The study started on 2007-03. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00456521?
The interventions under investigation include: Placebo (DRUG), Naltrexone SR 32 mg/ bupropion SR 360 mg/ day (DRUG), Intensive group lifestyle modification counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT00456521?
This trial is sponsored by Orexigen Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00456521's enrollment target sits among peer trials
793 429th of 2000 higher than 1,572 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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