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Naltrexone/Bupropion for Obesity

Phase 4
Recruiting
Led By Judith Korner, MD,PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks and 40 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if genetic variations affect weight loss with diet and an FDA-approved medication. Participants will attend visits, take tests & answer q's for a year.

Who is the study for?
This trial is for men and women aged 18-65 with obesity, defined as a BMI of 30-50, or overweight individuals (BMI 27-29.99) with certain weight-related health issues like controlled high blood pressure, cholesterol problems, sleep apnea, or joint arthritis.
What is being tested?
The study tests if genetic differences affect how well people lose weight on a calorie-restricted diet and the FDA-approved medication Naltrexone-Bupropion (NB). It's divided into three phases over one year: initial diet counseling and assessments; continued dieting plus NB treatment; then a wash-out period to see if genetics relate to maintaining weight loss.
What are the potential side effects?
While not explicitly listed in your information provided, common side effects of Naltrexone-Bupropion can include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth and diarrhea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks and 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks and 40 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Weight Loss (40 Weeks)
Secondary study objectives
Percent Excess Weight Loss
Percent Weight Loss
Percent of Participants Achieving ≥ 10% Weight Loss
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
Calorie restricted diet and treatment with Naltrexone/Bupropion

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,767,005 Total Patients Enrolled
43 Trials studying Obesity
5,965 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,333 Total Patients Enrolled
472 Trials studying Obesity
590,894 Patients Enrolled for Obesity
Judith Korner, MD,PhDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
386 Total Patients Enrolled
2 Trials studying Obesity
355 Patients Enrolled for Obesity

Media Library

All participants Clinical Trial Eligibility Overview. Trial Name: NCT05919797 — Phase 4
Obesity Research Study Groups: All participants
Obesity Clinical Trial 2023: All participants Highlights & Side Effects. Trial Name: NCT05919797 — Phase 4
All participants 2023 Treatment Timeline for Medical Study. Trial Name: NCT05919797 — Phase 4
~75 spots leftby Jun 2027
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