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Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

ConditionObesity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorColumbia University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Naltrexone-Bupropion Combination

    Drug

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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: All participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent Weight Loss (40 Weeks)

Percent weight loss from baseline to 40 weeks.

Time frame
Baseline and 40 Weeks

Secondary outcomes

1

Percent Excess Weight Loss

Percent excess weight loss defined as \[(initial weight - weight lost at week 40)/(initial weight - weight at a BMI 25kg/m2)\] x 100

Time frame
Baseline and 40 Weeks
2

Percent Excess Weight Loss

Percent excess weight loss defined as \[(Week 12 weight - weight lost at week 40)/(initial weight - weight at a BMI 25kg/m2)\] x 100

Time frame
12 Weeks and 40 Weeks
3

Percent of Participants Achieving ≥ 5% Weight Loss

Percent of participants achieving ≥ 5% weight loss at week 40

Time frame
Baseline and 40 Weeks
4

Percent of Participants Achieving ≥ 10% Weight Loss

Percent of participants achieving ≥ 10% weight loss at week 40

Time frame
Baseline and 40 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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