Clinical trial for Obesity
Official title Weight Loss Study: Genetics and Response to Naltrexone/Bupropion
ClinicalTrials.gov ID: NCT05919797
What this study is testing
What is Naltrexone-Bupropion Combination?
An investigational weight‑loss medication being studied for obesity. It is designed to act on brain pathways that regulate appetite and reward.
Also referred to as Contrave.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether certain genetic differences, like the Taq1A A1+ variant, lead to more weight loss when using the drug compared to other genotypes. It also looks at other genes that might change how well the drug works.
- Who it's for
- Adults who are obese and willing to follow a diet and take the medication.
- What's involved
- Participants get a calorie‑restricted diet plan, regular in‑person and phone visits, blood tests, an EKG, vital sign checks, questionnaires, and weight measurements. They also receive the medication for 28 weeks after the first 12 weeks of diet counseling.
- Time commitment
- The study lasts 40 weeks, with visits and tests during the first 12 weeks and again during the 28‑week medication period.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.