NCT06899178 Atomoxetine in Melanocortin Obesity Syndrome
| NCT ID | NCT06899178 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Melanocortin Obesity Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-09-01 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Joan C Han, MD
PRINCIPAL INVESTIGATOR
Mount Sinai Kravis Children's Hospital
Frequently Asked Questions
Who can join the NCT06899178 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Melanocortin Obesity Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06899178 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06899178 currently recruiting?
Yes, NCT06899178 is actively recruiting participants. Contact the research team at joan.han@mountsinai.org for enrollment information.
Where is the NCT06899178 trial being conducted?
This trial is being conducted at New York, United States, Columbus, United States, Nashville, United States.
Who is sponsoring the NCT06899178 clinical trial?
NCT06899178 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Joan C Han, MD at Mount Sinai Kravis Children's Hospital. The trial plans to enroll 20 participants.
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