NCT05919797 Weight Loss Study: Genetics and Response to Naltrexone/Bupropion
| NCT ID | NCT05919797 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Columbia University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-06-08 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2023-06-08 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: 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.
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
Contact & Investigator
Judith Korner, MD,PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05919797 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05919797 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05919797 currently recruiting?
Yes, NCT05919797 is actively recruiting participants. Contact the research team at jk181@cumc.columbia.edu for enrollment information.
Where is the NCT05919797 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05919797 clinical trial?
NCT05919797 is sponsored by Columbia University. The principal investigator is Judith Korner, MD,PhD at Columbia University. The trial plans to enroll 120 participants.
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