Melanocortin Obesity Syndrome study: Atomoxetine
Official title Atomoxetine in Melanocortin Obesity Syndrome
ClinicalTrials.gov ID: NCT06899178
What this study is testing
What is Atomoxetine?
An investigational oral medicine being studied as a potential treatment for obesity caused by melanocortin-4 receptor loss‑of‑function variants. It is designed to block the reuptake of norepinephrine, raising norepinephrine levels in the brain.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether atomoxetine is safe and works for obesity caused by MC4R gene changes.
- Who it's for
- You may be able to join if you have Melanocortin Obesity Syndrome caused by MC4R loss‑of‑function variants.
- What's involved
- You will take atomoxetine for a set time, then later take a pretend treatment with no medicine, or the reverse. You will visit the clinic to check safety and weight.
- Time commitment
- The study lasts several weeks and includes multiple clinic visits during each treatment period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Age 6 years and above
- Documented MC4R variant classified as pathogenic, likely pathogenic, or variant of uncertain significance per ACMG criteria.
- Obesity defined as BMI ≥30 kg/m2 in adults or ≥95th percentile for age and sex in children
You likely can't join if
- Use of atomoxetine, viloxazine (another selective norepinephrine-reuptake inhibitor), methylphenidate, amphetamine, dextroamphetamine...
- 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.
See the full eligibility criteria
- Age 6 years and above
- Documented MC4R variant classified as pathogenic, likely pathogenic, or variant of uncertain significance per ACMG criteria.
- Obesity defined as BMI ≥30 kg/m2 in adults or ≥95th percentile for age and sex in children
- Use of atomoxetine, viloxazine (another selective norepinephrine-reuptake inhibitor), methylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, phentermine, or any other stimulant medication in the past 30...
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.