Atomoxetine Tested Against Placebo for Melanocortin Obesity Syndrome
Tests atomoxetine versus placebo in people with genetic obesity from MC4R variants.
Key facts
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Where
- Columbus, Nashville, and New York, United StatesSee the 3 sites
- Trial code
- Registry title
- Atomoxetine in Melanocortin Obesity Syndrome
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 20 people, planned
- Started
- 1 Sept 2026
- Expected to end
- Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Atomoxetine
- Placebo
- Record updated
- 7 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with obesity caused by a change in the MC4R gene. It tests whether atomoxetine is safe and works, compared with a placebo.
- Age
- 6 years and older
- Sex
- All sexes
- Disease stage
- Obesity: BMI of 30 kg/m2 or more in adults, or at or above the 95th percentile for age and sex in children.
- Earlier treatment
- Cannot have used atomoxetine, viloxazine, methylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, phentermine or any other stimulant in the past 30 days. Other ADHD, weight loss or blood pressure medicines must be at a stable dose for more than 3 months. No weight loss of more than 5% in the past 3 months and no new weight loss program.
- Biomarker or test result
- A documented MC4R variant (pathogenic, likely pathogenic, or of uncertain significance). Results from a research lab must be confirmed by a CLIA-approved lab before randomization.
Main reasons for not taking part
- Pregnancy or plans to become pregnant in the next year
- Severe depression or other severe psychiatric disorder, or any suicidal behavior in the past month
- Heart rhythm problems, uncontrolled stage 2 high blood pressure, or history of pheochromocytoma
- Liver problems (cirrhosis, acute hepatitis) or narrow angle glaucoma
- Allergy to atomoxetine, current use of monoamine oxidase inhibitors, or being unable to swallow capsules
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Initiation of new weight loss program, including diet or medications. If on weight loss medications, must be on a stable dose for >3 months
- Current use of monoamine oxidase inhibitors
- History of hypersensitivity to atomoxetine
- 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
- History of a cardiac arrhythmia (not including bradycardia)
- 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)
- Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT >3x upper limit of normal)
- Weight loss >5% in the past 3 months
- Inability to swallow capsules
- Narrow angle glaucoma
- Uncontrolled asthma requiring albuterol more than once weekly over the past 3 months
- Pregnancy or intention to become pregnant during the next year
- 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
Where in United States
- Nationwide Children's HospitalColumbus, United StatesContact: Joan Han, MDNot yet recruiting
- Vanderbilt University Medical CenterNashville, United StatesContact: Jenny Leshko, RNNot yet recruiting
- Mount Sinai HospitalNew York, United StatesContact: Joan Han, MDTaking people
About the trial
What the trial wants to find out
This is a phase 2 randomized placebo-controlled crossover trial to determine the safety and efficacy of atomoxetine for treating obesity caused by loss-of-function variants in the melanocortin-4 receptor (MC4R), the most common cause of genetic obesity disorders. Atomoxetine was selected for this pilot trial because it has been shown to increase brain-derived neurotrophic factor (BDNF) within the central nervous system and in peripheral circulation. Targeting BDNF is a specific strategy for treating MC4R abnormalities because BDNF functions as a downstream mediator of MC4R signaling.
The 2 groups in the trial
- Placebo then AtomoxetinePlacebo, for comparison
Participants receive placebo for 16 weeks (4 weeks titration + 12 weeks at target dose), followed by washout period, then atomoxetine for 16 weeks (4 weeks titration + 12 weeks at target dose).
Treatment: Atomoxetine and Placebo
- Atomoxetine then PlaceboExisting treatment, for comparison
Participants receive atomoxetine for 16 weeks (4 weeks titration + 12 weeks at target dose), followed by washout period, then placebo for 16 weeks (4 weeks titration + 12 weeks at target dose).
Treatment: Atomoxetine and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2, Double Blind, Randomized, Placebo-controlled Crossover Trial to Evaluate the Efficacy and Safety of Atomoxetine in Adults With Melanocortin Obesity Syndrome
- Plain-language title
- Atomoxetine Tested Against Placebo for Melanocortin Obesity SyndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 7 August 2026