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NCT05919797 · ClinicalTrials.gov registry record · Phase 4
Weight Loss Study: Genetics and Response to Naltrexone/Bupropion
A Phase 4 study of Obesity, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05919797: Recruiting Phase 4 study of Obesity, sponsored by Columbia University.
NCT05919797 is a Phase 4 study of Obesity that is actively recruiting participants, run by Columbia University. The registered enrollment target is 120 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05919797, a Phase 4 study of Obesity, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to understand if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The main question\[s\] it aims to answer are: * In Aim One, the investigators propose to rigorously test the hypothesis that presence of the Taq1A A1+ polymorphism is associated with greater weight loss with NB compared with the A1- genotype. * In Aim Two, the investigators will explore other genetic polymorphisms that might influence the efficacy of NB such as the fat mass and obesity-associated (FTO) gene which modulates DRD2 signaling, as carriers of risk alleles in both the FTO and ANKK1 gene demonstrate altered responses to reward-learning tasks associated with negative outcomes. Participants will be in the study for 40 weeks, which consists of two phases: 1. From baseline to week 12, participants will receive individual nutritional counseling on a calorie restricted diet. This phase includes in-person visits, blood tests, an EKG, vital signs, questionnaires, body weight, and nutritional visits. 2. From week 12 to week 40, participants will continue to receive dietary counseling and will receive treatment with naltrexone/bupropion for 28 weeks. This phase includes in-person and phone visits, blood tests, vital signs, questionnaires, body weight, and nutritional visits.
Primary Outcome
Percent weight loss from baseline to 40 weeks.
Conditions Studied
Interventions
- DRUG Naltrexone-Bupropion Combination
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-06-08 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 4 |
What NCT05919797 shows while recruiting
NCT05919797 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (85% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Naltrexone-Bupropion Combination is the first listed.
NCT05919797 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05919797 about?
NCT05919797 is a clinical study titled "Weight Loss Study: Genetics and Response to Naltrexone/Bupropion". The goal of this clinical trial is to understand if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The main question\[s\] it aims to answer are: * In Aim One, the investigators propose to rigorously test the hy...
What is the current status of trial NCT05919797?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2023-06-08. Estimated completion is 2027-06-30.
What conditions does trial NCT05919797 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT05919797?
The interventions under investigation include: Naltrexone-Bupropion Combination (DRUG).
Who is sponsoring clinical trial NCT05919797?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05919797 being conducted?
This trial has 1 study location across New York. 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 NCT05919797's enrollment target sits among peer trials
120 434th of 1053 higher than 607 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
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