Atomoxetine in Melanocortin Obesity Syndrome

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called atomoxetine to see if it can help treat obesity caused by a specific genetic condition known as Melanocortin Obesity Syndrome (MCOS). This condition is often linked to changes in a gene that affects how the body regulates weight. The trial is in its early stages (Phase 2) and aims to understand how safe and effective atomoxetine is for people with this condition. Participants must be at least 6 years old and have a confirmed genetic change in the melanocortin-4 receptor that is linked to obesity.

To participate, individuals must have a body mass index (BMI) indicating obesity, but they should not have recently lost a significant amount of weight or be on certain medications. During the trial, participants will receive either atomoxetine or a placebo (a non-active substance) for some time, followed by a switch to the other treatment. This process helps researchers compare the effects of the medication against no treatment. It's important to know that individuals with certain health conditions or those who are pregnant are not eligible to join this study. If you think you or someone you know might qualify, discussing participation with a healthcare provider could provide more personalized information.

Gender

ALL

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