Atomoxetine in Melanocortin Obesity Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorIcahn School of Medicine at Mount Sinai
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 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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Atomoxetine
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
Vanderbilt University Medical Center
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov