Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05919797
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Naltrexone-Bupropion Combination — DRUG
    Participants receive 28 weeks of naltrexone-bupropion weight loss medication during phase two of this study.

Study Details

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.

Key Dates

Start date
Jun 8, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: All participants
    Calorie restricted diet and treatment with Naltrexone/Bupropion

Primary Outcome Measure

Percent Weight Loss (40 Weeks) [ Time Frame: Baseline and 40 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Judith Korner, MD
[email protected]
212-305-4006
Sarah Borden, MPH
[email protected]
212-305-4006

Find similar trials in New York, NY

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Columbia University Medical Center· New York, NY

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