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NCT01601704 · ClinicalTrials.gov registry record · Phase 3
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
A Phase 3 study, sponsored by Orexigen Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 8,910
- Enrollment target
NCT01601704: Clinical Trial Phase 3 study, sponsored by Orexigen Therapeutics.
NCT01601704 is a Phase 3 study that was terminated before completion, run by Orexigen Therapeutics. The registered enrollment target is 8,910 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1056% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01601704, a Phase 3 study, was terminated before completion, sponsored by Orexigen Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 8,910 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.
Primary Outcome
The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.
Interventions
- DRUG PBO
- DRUG NB32
- BEHAVIORAL Weight Management Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,910 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
Why NCT01601704 stopped before completion
NCT01601704 is an interventional study that assigns participants to a tested intervention. Its 8,910 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1056% higher).
The record links to 0 conditions, and to 3 interventions - of which PBO is the first listed.
NCT01601704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01601704 about?
NCT01601704 is a clinical study titled "Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)". The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because t...
What is the current status of trial NCT01601704?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 8,910 participants. The study started on 2012-06. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01601704?
The interventions under investigation include: PBO (DRUG), NB32 (DRUG), Weight Management Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT01601704?
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 NCT01601704's enrollment target sits among peer trials
8,910 32nd of 2000 higher than 1,969 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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