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Atomoxetine in Melanocortin Obesity Syndrome
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
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.
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
Key Details
Gender
All
Age Range
6 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-04
Completion Date
2028-07
Last Updated
2025-03-27
Healthy Volunteers
No
Conditions
Interventions
Atomoxetine
Initial dose 40 mg, day 7 dose 60 mg, day 14 dose 80 mg, day 21 dose 100 mg (target dose)
Placebo
Matching placebo oral capsule
Locations (2)
Mount Sinai Hospital
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States