drugset / Trial / NCT06899178
Atomoxetine in Melanocortin Obesity Syndrome
Phase 2
Not yet recruiting
20 enrolled
Icahn School of Medicine at Mount Sinai
Vanderbilt University Medical Center · collab
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-04
- Primary completion
- 2028-07
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atomoxetine | Other / unclassified | 100 mg | — |