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New treatment option 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?
Naltrexone-Bupropion Combination is an investigational medicine, being studied as a potential treatment for obesity.
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 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.
- 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's taking place
- 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 - 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?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.