RightFit
RecruitingPhase 4

Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

Association of Genetic Variations and Weight Loss Response to Naltrexone/Bupropion

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 40 weeks, 28 weeks
  • Procedures mentioned: Blood draws, Heart tracing (ECG), Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be in the study for 40 weeks, which consists of two phases: 1."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

NY