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Atomoxetine in Melanocortin Obesity Syndrome

RecruitingPhase 2

Sponsor: Icahn School of Medicine at Mount Sinai

Conditions: Melanocortin Obesity Syndrome, MCOS

Interventions: Atomoxetine, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 6 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* Age 6 years and above
* Documented MC4R variant classified as pathogenic, likely pathogenic, or variant of uncertain significance per ACMG criteria. If testing was done in a research lab, it will be confirmed by a CLIA-approved lab prior to randomization.
* Obesity defined as BMI ≥30 kg/m2 in adults or ≥95th percentile for age and sex in children

Exclusion criteria:

* Use of atomoxetine, viloxazine (another selective norepinephrine-reuptake inhibitor), methylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, phentermine, or any other stimulant medication in the past 30 days. If on other ADHD medications, such as guanfacine and clonidine, must be on a stable dose for \>3 months.
* Weight loss \>5% in the past 3 months.
* Initiation of new weight loss program, including diet or medications. If on weight loss medications, must be on a stable dose for \>3 months.
* Inability to swallow capsules.
* History of hypersensitivity to atomoxetine.
* Narrow angle glaucoma.
* History of pheochromocytoma.
* Uncontrolled Stage 2 hypertension (≥95th percentile + 12 mmHg or \>140/90, whichever is lower) at screening. If on antihypertensive medication, must be on stable dose for \>3 months.
* Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \>3x upper limit of normal)
* Uncontrolled asthma requiring albuterol more than once weekly over the past 3 months
* History of a cardiac arrhythmia (not including bradycardia)
* Current use of monoamine oxidase inhibitors
* Pregnancy or intention to become pregnant during the next year
* History of Major Depressive Disorder in the past 2 years, lifetime history of suicide attempt, history of any suicidal behavior in the past month, history of other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder)
* PHQ-9 score is ≥15 or suicidal ideation of type 4 or 5 (C-SSR) in the past month
* Unable to comply with study procedures in the opinion of the investigator

Locations (3)

New York, New York, United States
Columbus, Ohio, United States
Nashville, Tennessee, United States