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Can a common ADHD drug curb genetic obesity?

NCT ID NCT06899178

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This phase 2 trial is testing whether atomoxetine, a drug used for ADHD, can help adults with melanocortin obesity syndrome (MCOS), a genetic condition that causes severe obesity. The drug may boost a brain protein called BDNF, which is part of the pathway disrupted in MCOS. Participants will receive either atomoxetine or a placebo in a crossover design, and researchers will measure changes in body mass index and energy expenditure.

What this could mean

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

Active substance
atomoxetine
What this could lead to
If atomoxetine proves effective, it could become a targeted treatment for a rare genetic form of obesity, offering a new option for people who have few choices.
What could go wrong
This is a small early-stage trial, so results may not hold up in larger studies. Atomoxetine can cause side effects like nausea, dry mouth, or increased heart rate, and it may not work for everyone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

6 years and older

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: * Age 6 years and above * Documented MC4R variant classified as pathogenic, likely pathogenic, or variant of uncertain significance per ACMG criteria. If testing was done in a research lab, it will be confirmed by a CLIA-approved lab prior to randomization. * Obesity defined as BMI ≥30 kg/m2 in adults or ≥95th percentile for age and sex in children Exclusion criteria: * Use of atomoxetine, viloxazine (another selective norepinephrine-reuptake inhibitor), methylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, phentermine, or any other stimulant medication in the past 30 days. If on other ADHD medications, such as guanfacine and clonidine, must be on a stable dose for \>3 months. * Weight loss \>5% in the past 3 months. * Initiation of new weight loss program, including diet or medications. If on weight loss medications, must be on a stable dose for \>3 months. * Inability to swallow capsules. * History of hypersensitivity to atomoxetine. * Narrow angle glaucoma. * History of pheochromocytoma. * Uncontrolled Stage 2 hypertension (≥95th percentile + 12 mmHg or \>140/90, whichever is lower) at screening. If on antihypertensive medication, must be on stable dose for \>3 months. * Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \>3x upper limit of normal) * Uncontrolled asthma requiring albuterol more than once weekly over the past 3 months * History of a cardiac arrhythmia (not including bradycardia) * Current use of monoamine oxidase inhibitors * Pregnancy or intention to become pregnant during the next year * History of Major Depressive Disorder in the past 2 years, lifetime history of suicide attempt, history of any suicidal behavior in the past month, history of other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder) * PHQ-9 score is ≥15 or suicidal ideation of type 4 or 5 (C-SSR) in the past month * Unable to comply with study procedures in the opinion of the investigator

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Conditions

The condition(s) this trial relates to.

Obesity Weight Loss

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. 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

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Nationwide Children's Hospital

    NOT_YET_RECRUITING

    Columbus, Ohio, 43205, United States

  • Vanderbilt University Medical Center

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States