Understanding how genetics affect weight loss with a medication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to investigate the relationship between genetic variations and weight loss outcomes in individuals taking the FDA-approved medication naltrexone/bupropion for obesity. Participants will undergo a 40-week program that includes nutritional counseling and the medication, with a focus on identifying genetic factors that may influence their response to treatment. The study will specifically examine the Taq1A A1+ polymorphism and other genetic markers to determine their association with weight loss efficacy. By personalizing obesity treatment based on genetic profiles, the study seeks to improve long-term weight loss outcomes for individuals struggling with obesity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Columbia University Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Judith Korner, MD,PhD — Columbia University
• Study coordinator: Judith Korner, MD,PhD
• Email: jk181@cumc.columbia.edu
• Phone: 212-305-4006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.