Atomoxetine for Melanocortin Obesity Syndrome

Atomoxetine in Melanocortin Obesity Syndrome

Recruiting Phase 2 Interventional Study
Melanocortin Obesity Syndrome MCOS
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
6 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
Who this trial is looking for

This trial is looking for children and adults who have a specific genetic condition called Melanocortin Obesity Syndrome and are struggling with obesity. Participants will take a medication called atomoxetine to see if it helps with their weight.

Are You a Good Fit for This Trial?
Must not be taking AtomoxetineViloxazineMethylphenidateAmphetamineDextroamphetamineLisdexamfetamine
Rules you out Narrow angle glaucomaPheochromocytomaHepatic insufficiencyUncontrolled asthmaCardiac arrhythmia

You may be able to join if

  • I am 6 years old or older.
  • I have been diagnosed with a pathogenic or likely pathogenic MC4R variant.
  • I have obesity defined as a BMI of at least 30 or am above the 95th percentile for my age and sex.

You may not be able to join if

  • I have used certain stimulant medications in the past 30 days.
  • I have lost more than 5% of my weight in the past 3 months.
  • I have started a new weight loss program recently.
  • I cannot swallow capsules.
  • I have a history of hypersensitivity to atomoxetine.
  • I have uncontrolled high blood pressure.
  • I have or have had major depression or severe psychiatric disorders.
  • I am pregnant or plan to become pregnant in the next year.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 …
Trial Locations
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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 …
Contacts

Joan C Han, MD

212-241-3744

joan.han@mountsinai.org

CONTACT