Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

This study aims to understand how your genes might affect how much weight you lose when using the medication naltrexone-bupropion. Researchers want to see if specific genetic differences are linked to better weight loss results. You could be eligible if you are between 18 and 65 years old and have a BMI (Body Mass Index) of 30-50 kg/m2, or a BMI of 27-29.99 kg/m2 with certain weight-related health issues like controlled high blood pressure. The main goal is to measure your percentage of weight loss over 40 weeks. This study is currently unclear on its recruitment status and plans to enroll 120 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 120 participants.
What's involved
Participants will receive naltrexone-bupropion medication for 28 weeks during phase two of the study.
Compensation
Not stated in the trial record.
Follow-up
Your weight loss will be measured at baseline and again at 40 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05919797

Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

Recruiting
PHASE4Ages 18–65Interventional
Columbia University
~120 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Naltrexone-Bupropion Combination

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Weight Loss (40 Weeks)
Measured over Baseline and 40 Weeks
Obesity
1 sites across 1 states
New York1
  • Judith Korner, MD,PhD · PRINCIPAL_INVESTIGATOR · Columbia University

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Eligibility criteria

Inclusion

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.

Exclusion

Obesity of known endocrine or hypothalamic origin
HbA1c \> 6.5%
Cerebrovascular, cardiovascular, hepatic or renal disease
History of seizures, serious psychiatric illness or suicide attempts, drug or alcohol misuse within prior 24 months
Glaucoma
Current tobacco use on a regular basis
Use of dopamine agonists, opioid analgesics, antipsychotics, antidepressants, neuroleptics, naltrexone, diabetes medications
Use of Monoamine oxidase (MAO) inhibitors \< 14 days prior to screening
Concomitant use of CYP2B6 inhibitors
History of anorexia nervosa or bulimia
Previous surgery for obesity
Weight loss device intervention within prior 2 years
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)
Clinically significant thyroid disease
Triglycerides \> 499 mg/dl
Current use or use of weight loss medication within prior six months
Any lifetime weight change deemed significant by Principal Investigator
An affirmative answer to any question in the Columbia-Suicide Severity Rating Scale
  • Percent Weight Loss (40 Weeks)Baseline and 40 Weeks

    Percent weight loss from baseline to 40 weeks.