NCT05919797

Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

Recruiting now Phase 4 Last updated 7 May 2025

What this trial tests

Phase 4 trial testing Naltrexone-Bupropion Combination in Obesity in 120 participants. Currently enrolling.

Timeline

8 June 2023

Primary endpoint
30 June 2027

30 June 2027

Quick facts

Lead sponsor	Columbia University
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	120
Start date	8 June 2023
Primary completion	30 June 2027
Estimated completion	30 June 2027
Sites	1 location across United States

Drugs / interventions tested

• Naltrexone-Bupropion Combination — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Columbia University

Who can join

Adults 18 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.