Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

NCT05919797 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: AAAU3131R01DK132527
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• 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.
• 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

Obesity

Keywords

Obesity; Weight loss

Outcome Measures

Primary Outcomes (1)

• Percent Weight Loss (40 Weeks)

  Percent weight loss from baseline to 40 weeks.

  Baseline and 40 Weeks

Secondary Outcomes (5)

• Percent Excess Weight Loss

  Baseline and 40 Weeks

• Percent Excess Weight Loss

  12 Weeks and 40 Weeks

• Percent of Participants Achieving ≥ 5% Weight Loss

  Baseline and 40 Weeks

• Percent of Participants Achieving ≥ 10% Weight Loss

  Baseline and 40 Weeks

• Percent Weight Loss

  12 weeks and 40 weeks

Study Arms (1)

All participants

EXPERIMENTAL

Calorie restricted diet and treatment with Naltrexone/Bupropion

Drug: Naltrexone-Bupropion Combination

Interventions

Naltrexone-Bupropion Combination DRUG

Participants receive 28 weeks of naltrexone-bupropion weight loss medication during phase two of this study.

Also known as: Contrave

All participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Naltrexone-Bupropion combination; bupropion hydrochloride, naltrexone hydrochoride drug combination

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Judith Korner, MD,PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Korner, MD,PhD

CONTACT

212-305-4006; jk181@cumc.columbia.edu

Sarah Borden, MPH

CONTACT

212-305-4006; sb1097@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: June 8, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)