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Can your DNA predict weight loss success? new study tests contrave

NCT ID NCT05919797

Disease control Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study investigates whether certain genetic variations influence how much weight people lose when taking the FDA-approved weight loss drug Contrave (naltrexone/bupropion). Over 40 weeks, 120 adults with obesity will first follow a calorie-restricted diet for 12 weeks, then add Contrave for 28 weeks. Researchers will analyze DNA to see if specific gene variants are linked to greater weight loss, aiming to personalize obesity treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Naltrexone-Bupropion (Contrave)
What this could lead to
If successful, this could help doctors predict who will lose the most weight with Contrave based on their genes, making weight loss treatment more personalized.
What could go wrong
This is a small, early-phase study (120 people) focused on genetic links, not a direct test of the drug's effectiveness. Results may not apply to everyone, and weight loss varies widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

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