Status:
NOT_YET_RECRUITING
Atomoxetine in Melanocortin Obesity Syndrome
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Vanderbilt University Medical Center
Conditions:
Melanocortin Obesity Syndrome
MCOS
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief 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 recep...
Detailed Description
Targeted therapies for the treatment of monogenetic obesity are essential because typical lifestyle interventions and standard anti-obesity medications are largely ineffective as they do not correct t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06899178
Start Date
April 1 2025
End Date
July 1 2028
Last Update
March 27 2025
Active Locations (2)
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1
Mount Sinai Hospital
New York, New York, United States, 10029
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232