NCT05919797RecruitingPhase 4
Weight Loss Study: Genetics and Response to Naltrexone/Bupropion
Association of Genetic Variations and Weight Loss Response to Naltrexone/Bupropion
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 16 Jun 2023
- Start date
- 8 Jun 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Columbia University
- Diseases
- Obesity
- NCT number
- NCT05919797
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 8 Jun 2023 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of seizures, serious psychiatric illness or suicide attempts, drug or alcohol misuse within prior 24 months
- Use of Monoamine oxidase (MAO) inhibitors \< 14 days prior to screening
- Concomitant use of CYP2B6 inhibitors
- Previous surgery for obesity
- Weight loss device intervention within prior 2 years
- Current use or use of weight loss medication within prior six months
Other illness
- Cerebrovascular, cardiovascular, hepatic or renal disease
- Use of dopamine agonists, opioid analgesics, antipsychotics, antidepressants, neuroleptics, naltrexone, diabetes medications
- History of anorexia nervosa or bulimia
- Clinically significant thyroid disease
Lab values
- HbA1c \> 6.5%
- Triglycerides \> 499 mg/dl
Other
- Obesity of known endocrine or hypothalamic origin
- Glaucoma
- Current tobacco use on a regular basis
- Currently pregnant or lactating, planning pregnancy or refusal to use birth control when appropriate (Women of childbearing potential will be required to use effective contraception.)
- Blood pressure \> 145/95 (use of anti-hypertensives will be allowed with the exception of verapamil, which can cause hyperprolactinemia)
- Any lifetime weight change deemed significant by Principal Investigator
- An affirmative answer to any question in the Columbia-Suicide Severity Rating Scale
Who the study is looking for
- Men and women ages 18-65 years
- BMI 30-50 kg/m2 or
- BMI 27-29.99 kg/m2 with at least one weight-related comorbidity including controlled hypertension, dyslipidemia, obstructive sleep apnea, or osteoarthritis of a weight-bearing joint.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.