Clinical Trial

Atomoxetine in Melanocortin Obesity Syndrome

Study acronym: MCOS
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-08-08
notable Primary completion moved earlier: 2028-07 -> 2028-03 2026-08-08
minor Completion moved earlier: 2028-07 -> 2028-06 2026-08-08
Trial Details
NCT Number NCT06899178
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Vanderbilt University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Melanocortin Obesity Syndrome, MCOS
Enrollment 20 participants
Start Date 2026-09-01
Primary Completion 2028-03 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-07