Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01764386 · ClinicalTrials.gov registry record · Phase 3
Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
A Phase 3 study of Obesity and Overweight, sponsored by Orexigen Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
- 15
- Study locations
NCT01764386: Completed Phase 3 study of Obesity and Overweight, sponsored by Orexigen Therapeutics.
NCT01764386 is a Phase 3 study of Obesity and Overweight that has completed, run by Orexigen Therapeutics. The registered enrollment target is 242 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (70% lower). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764386, a Phase 3 study of Obesity and Overweight, has completed, sponsored by Orexigen Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).
Conditions Studied
Interventions
- BEHAVIORAL Usual Care
- DRUG NB
- BEHAVIORAL CLI
Study Locations (15)
North Carolina
- PMG Research of Raleigh - Cary
- PMG Research of Winston-Salem - Hickory
- PMG Research of Raleigh - Raleigh
- PMG Research of Salisbury - Salisbury
- PMG Research of Wilmington, LLC - Wilmington
South Carolina
- Radiant Research - Anderson
- Radiant Research, Greer - Greer
- PMG Research of Charleston - Mt. Pleasant
Ohio
- Radiant Research-Akron - Akron
- Radiant Research, Inc. - Columbus
Colorado
- Radiant Research - Denver
Missouri
- Radiant Research, Inc. - St Louis
Tennessee
- PMG Research of Bristol - Bristol
Texas
- Radiant Research Dallas-North - Dallas
Utah
- Radiant Research, SLC - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01764386 record still lists
NCT01764386 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Usual Care is the first listed.
NCT01764386 lists 15 locations in 8 states (North Carolina, South Carolina, Ohio).
Frequently Asked Questions
What is clinical trial NCT01764386 about?
NCT01764386 is a clinical study titled "Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects". The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular r...
What is the current status of trial NCT01764386?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2013-02. Estimated completion is 2014-09.
What conditions does trial NCT01764386 study?
This clinical trial studies the following conditions: Obesity, Overweight.
What interventions are being tested in trial NCT01764386?
The interventions under investigation include: Usual Care (BEHAVIORAL), NB (DRUG), CLI (BEHAVIORAL).
Who is sponsoring clinical trial NCT01764386?
This trial is sponsored by Orexigen Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01764386 being conducted?
This trial has 15 study locations across Colorado, Missouri, North Carolina, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01764386's enrollment target sits among peer trials
242 269th of 1053 higher than 785 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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
-
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
RECRUITING · Phase 3
-
Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
RECRUITING · Phase 3
-
A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight
RECRUITING · Phase 3
-
A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
RECRUITING · Phase 3
-
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
RECRUITING · Phase 3
-
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03556228 · 242 participants · Phase 1
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
- NCT04260022 · 242 participants · Phase 1
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
- NCT04459000 · 242 participants · NA
Substance Use Treatment and Access to Resources (STARS) Project
- NCT05644496 · 242 participants · Phase 4
ZYNRELEF for Pain Management in Total Knee Arthroplasty
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia