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NOT YET RECRUITING
NCT06899178
PHASE2

Atomoxetine in Melanocortin Obesity Syndrome

Sponsor: Icahn School of Medicine at Mount Sinai

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.

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

Interventions

DRUG

Atomoxetine

Initial dose 40 mg, day 7 dose 60 mg, day 14 dose 80 mg, day 21 dose 100 mg (target dose)

DRUG

Placebo

Matching placebo oral capsule

Locations (2)

Mount Sinai Hospital

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States