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Search / Trial NCT06899178

Atomoxetine in Melanocortin Obesity Syndrome

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

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

Obesity Bdnf Mc4 R Atomoxetine Energy Balance Weight Loss

ClinConnect Summary

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 the specific genetic defect causing abnormal energy balance. The leptin pathway is the key regulator of body weight through control of appetite and energy expenditure. In particular, the severe insatiable hunger experienced by patients with leptin pathway disorders leads not only to extreme obesity, but the unrelenting drive to seek food also causes substantial distress for patients and caregive...

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

Trial Officials

Joan C Han, MD

Principal Investigator

Mount Sinai Kravis Children's Hospital

Ashley H Shoemaker, MD, MSCI

Principal Investigator

Vanderbilt University Medical Center

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

Nashville, Tennessee, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported