Tests whether genes affect weight loss from naltrexone and bupropion
Tests whether genes relate to weight loss with a drug in adults with obesity.
Key facts
- Who runs it
- Columbia University
- Where
- New York, United StatesSee the site
- Trial code
- Registry title
- Weight Loss Study: Genetics and Response to Naltrexone/Bupropion
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 120 people, planned
- Started
- 8 Jun 2023
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional
- Treatments tested
- Naltrexone-Bupropion Combination
- Record updated
- 10 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity, or with overweight and a weight-related health problem. People follow a calorie-restricted diet, then take naltrexone/bupropion.
- Age
- 18 to 65 years
- Sex
- Men and women
- Disease stage
- BMI 30-50 kg/m2, or BMI 27-29.99 kg/m2 with at least one weight-related condition: controlled hypertension, dyslipidemia, obstructive sleep apnea, or osteoarthritis of a weight-bearing joint.
- Earlier treatment
- People who used weight loss medication within the prior six months, had surgery for obesity, or had a weight loss device within the prior 2 years cannot join.
Main reasons for not taking part
- Obesity of known endocrine or hypothalamic origin
- HbA1c above 6.5% (48 mmol/mol)
- Heart, brain blood vessel, liver or kidney disease
- History of seizures, serious psychiatric illness, suicide attempts, or drug or alcohol misuse within the prior 24 months
- Currently pregnant or breastfeeding, or planning pregnancy
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- HbA1c > 6.5%
- Triglycerides > 499 mg/dl
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- Columbia University Medical CenterNew York, United StatesContact: Judith Korner, MDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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.
The group in the trial
- All participantsTreatment being tested
Calorie restricted diet and treatment with Naltrexone/Bupropion
Treatment: Naltrexone-Bupropion Combination
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Association of Genetic Variations and Weight Loss Response to Naltrexone/Bupropion
- Plain-language title
- Tests whether genes affect weight loss from naltrexone and bupropionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05919797, who can take part
- Record updated
- 10 June 2026