Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
Who this trial is looking for
This trial is looking for children and adults who have a specific genetic condition called Melanocortin Obesity Syndrome and are struggling with obesity. Participants will take a medication called atomoxetine to see if it helps with their weight.
Are You a Good Fit for This Trial?
Must not be takingAtomoxetineViloxazineMethylphenidateAmphetamineDextroamphetamineLisdexamfetamine
Rules you outNarrow angle glaucomaPheochromocytomaHepatic insufficiencyUncontrolled asthmaCardiac arrhythmia
You may be able to join if
I am 6 years old or older.
I have been diagnosed with a pathogenic or likely pathogenic MC4R variant.
I have obesity defined as a BMI of at least 30 or am above the 95th percentile for my age and sex.
You may not be able to join if
I have used certain stimulant medications in the past 30 days.
I have lost more than 5% of my weight in the past 3 months.
I have started a new weight loss program recently.
I cannot swallow capsules.
I have a history of hypersensitivity to atomoxetine.
I have uncontrolled high blood pressure.
I have or have had major depression or severe psychiatric disorders.
I am pregnant or plan to become pregnant in the next year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 …
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
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