Actively Recruiting
Weight Loss Study: Genetics and Response to Naltrexone/Bupropion
Led by Columbia University · Updated on 2025-05-07
120
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Weight Loss Study: Genetics and Response to Naltrexone/Bupropion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women ages 18-65 years
- Body mass index (BMI) 30-50 kg/m2 or BMI 27-29.99 kg/m2 with at least one weight-related condition such as controlled hypertension, dyslipidemia, obstructive sleep apnea, or osteoarthritis of a weight-bearing joint
You will not qualify if you...
- Obesity caused by known endocrine or hypothalamic problems
- Hemoglobin A1c greater than 6.5%
- Cerebrovascular, cardiovascular, liver, or kidney disease
- History of seizures, serious psychiatric illness, suicide attempts, or drug/alcohol misuse in the past 24 months
- Glaucoma
- Regular tobacco use
- Use of dopamine agonists, opioid painkillers, antipsychotics, antidepressants, neuroleptics, naltrexone, or diabetes medications
- Use of Monoamine oxidase (MAO) inhibitors within 14 days before screening
- Use of CYP2B6 inhibitors
- History of anorexia nervosa or bulimia
- Previous weight loss surgery
- Weight loss device use within the past 2 years
- Currently pregnant, breastfeeding, planning pregnancy, or refusing birth control when appropriate
- Blood pressure over 145/95 (except when using anti-hypertensives other than verapamil)
- Significant thyroid disease
- Triglycerides over 499 mg/dl
- Current or recent (within 6 months) use of weight loss medication
- Any significant lifetime weight change as judged by the Principal Investigator
- Positive response to any question on the Columbia-Suicide Severity Rating Scale
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
J
Judith Korner, MD,PhD
CONTACT
S
Sarah Borden, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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