Back to search results

Atomoxetine for Melanocortin Obesity Syndrome

This study is testing Atomoxetine to see if it can help treat obesity in people with Melanocortin Obesity Syndrome (MCOS). MCOS is a genetic condition where a specific gene (MC4R) doesn't work properly, leading to severe obesity. Researchers believe Atomoxetine might work by affecting a substance in the brain called brain-derived neurotrophic factor (BDNF), which plays a role in how the MC4R gene normally functions. You might be able to join if you are 6 years or older, have a confirmed MC4R gene change, and meet specific criteria for obesity. The main goal is to see how Atomoxetine affects your Body Mass Index (BMI) after 16 weeks. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is a randomized, placebo-controlled crossover study, meaning participants will receive both Atomoxetine and a placebo (an inactive pill) at different times. It is a pilot trial, planning to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your Body Mass Index (BMI) will be measured at 16 weeks to see the effects of the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06899178

Atomoxetine in Melanocortin Obesity Syndrome

Recruiting
PHASE2Ages 6+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~20 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:AtomoxetinePlacebo

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body Mass Index (BMI)
Measured over 16 weeks

Conditions

Melanocortin Obesity Syndrome
MCOS

Explore related trials

Melanocortin Obesity SyndromeObesityMelanocortin Receptor 4

Where it's being run

3 sites across 3 states
New York1
Ohio1
Tennessee1

Study leadership

  • Joan C Han, MD · PRINCIPAL_INVESTIGATOR · Mount Sinai Kravis Children's Hospital
  • Ashley H Shoemaker, MD, MSCI · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Joan C Han, MD
[email protected]
212-241-3744 · ext. 301-312-7
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Body Mass Index (BMI)16 weeks

    BMI will be calculated as kg/sq m. The sex appropriate CDC growth chart will be used to calculate BMI as a percent of the 95th percentile (BMI95). For patients \>20 years, the 20-year-old percentiles will be used.