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Atomoxetine in Melanocortin Obesity Syndrome

Study acronym: MCOS
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Recruitment openedv2 Show 5 more changesShow less
    • Start date: Apr 2025 to Sep 1, 2026
    • Primary completion moved earlier from Jul 2028 to Mar 2028
    • Study completion moved earlier from Jul 2028 to Jun 2028
    • Study sites: 2 to 3
    • Collaborators: 1 to 2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Melanocortin Obesity Syndrome, MCOS
Related terms Obesity, Weight Loss
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov