Atomoxetine in Melanocortin Obesity Syndrome

Conditions

• MCOS
• Melanocortin Obesity Syndrome

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atomoxetine — DRUG
  Initial dose 40 mg, day 7 dose 60 mg, day 14 dose 80 mg, day 21 dose 100 mg (target dose)
• Placebo — DRUG
  Matching placebo oral capsule

Study Details

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.

Key Dates

Start date

Apr 30, 2025

Status verified

Mar 2025

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo then Atomoxetine
  Participants receive placebo for 16 weeks (4 weeks titration + 12 weeks at target dose), followed by washout period, then atomoxetine for 16 weeks (4 weeks titration + 12 weeks at target dose).
• Active Comparator: Atomoxetine then Placebo
  Participants receive atomoxetine for 16 weeks (4 weeks titration + 12 weeks at target dose), followed by washout period, then placebo for 16 weeks (4 weeks titration + 12 weeks at target dose).

Primary Outcome Measure

Body Mass Index (BMI) [ Time Frame: 16 weeks ]

Central Contacts

• Joan C Han, MD
  212-241-3744
  [email protected]

Locations (2)

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