Your session is about to expire
← Back to Search
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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks and 40 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks and 40 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Weight Loss (40 Weeks)
Secondary outcome measures
Percent Excess Weight Loss
Percent Weight Loss
Percent of Participants Achieving ≥ 10% Weight Loss
+1 moreTrial 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
1,433 Previous Clinical Trials
2,447,139 Total Patients Enrolled
40 Trials studying Obesity
5,874 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,472 Total Patients Enrolled
446 Trials studying Obesity
588,818 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My current weight is more than 5% less than my highest weight ever.I am not taking drugs that interfere with CYP2B6.I have had surgery to help with weight loss.My BMI is between 30-50, or 27-29.99 with a weight-related health issue.I have glaucoma.I have not used a weight loss device in the last 2 years.I have not used weight loss medication in the last six months.I am between 18 and 65 years old.My blood pressure is over 145/95, but I can take medication for it, except for verapamil.I am currently taking medication for mood, pain, diabetes, or addiction.My obesity is caused by an endocrine or brain-related condition.I have a history of stroke, heart, liver, or kidney disease.I have not taken MAO inhibitors in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: All participants
Awards:
This trial has 3 awards, including:- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do individuals below a certain age have access to this clinical research?
"We are seeking patients aged 18 and over, but younger than 65, to participate in this clinical trial."
Answered by AI
Is there a path for me to become involved with this clinical research?
"Qualifying participants must meet the criteria of obesity and being between 18-65 years old. This clinical trial has a cap on its enrollment, with only 120 candidates accepted to participate."
Answered by AI
To what degree can individuals trust the safety of All participants?
"There is extant clinical data that establishes the safety of this treatment, thus it received a rating of 3. This drug has already been approved for use in Phase 4 trials."
Answered by AI
What is the current capacity of enrollees for this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that this medical trial is recruiting, with the initial posting date of June 8th 2023 and most recent update on June 16th 2023. A total of 120 participants are sought after from a single site."
Answered by AI
Is this experiment presently welcoming participants?
"Indeed, the information on clinicaltrials.gov states that this research project is in active recruitment mode. The study was posted on June 8th 2023 and has since been updated as recently as June 16th 2023. They are hoping to enroll 120 patients at one medical centre."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger