Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

Launched by COLUMBIA UNIVERSITY · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Weight Loss Study: Genetics and Response to Naltrexone/Bupropion, aims to find out how our genes affect weight loss when using a specific FDA-approved medication for obesity. The researchers want to see if certain genetic traits, like the Taq1A A1+ polymorphism, influence how much weight participants can lose with diet and the medication. They will also look at other genes that may play a role in weight loss success.

To participate in this trial, you need to be between 18 and 65 years old and have a body mass index (BMI) between 27 and 50, which means you might be classified as overweight or obese. The study lasts for 40 weeks, starting with 12 weeks of personalized dietary counseling followed by 28 weeks of continued counseling along with the medication treatment. Throughout the trial, participants will have regular check-ins with the study team, including health assessments and support with their weight loss journey. This study not only hopes to improve weight loss strategies but also aims to understand more about how our genetics can affect our responses to treatment.

Gender

ALL

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