Understanding how genetics affect weight loss with a medication

Association of Genetic Variations and Weight Loss Response to Naltrexone/Bupropion

This study is testing how certain genes might affect weight loss in people taking a medication for obesity, to see if personalizing treatment can help them lose weight better.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Columbia University (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05919797 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18-65 with a BMI between 27-50 kg/m2 and at least one weight-related comorbidity.

Not a fit: Patients with obesity due to known endocrine or hypothalamic causes or those with significant comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective weight loss treatments based on genetic profiles.

How similar studies have performed: Other studies have shown promise in personalizing obesity treatment based on genetic factors, but this specific approach is relatively novel.

Eligibility criteria

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 this trial is running

New York, New York

• 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

Conditions: Obesity, Weight loss