Atomoxetine in Melanocortin Obesity Syndrome
Eligible age
6+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: Icahn School of Medicine at Mount Sinai
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06899178 · last updated 2026-08-07