[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mcos\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mcos":15},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100585193","phase-2-atomoxetine-in-melanocortin-obesity-syndrome-100585193",false,"NCT06899178","Atomoxetine in Melanocortin Obesity Syndrome","A Phase 2, Double Blind, Randomized, Placebo-controlled Crossover Trial to Evaluate the Efficacy and Safety of Atomoxetine in Adults With Melanocortin Obesity Syndrome","MCOS","Inclusion criteria:\n\n* Age 6 years and above\n* 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.\n* Obesity defined as BMI ≥30 kg\u002Fm2 in adults or ≥95th percentile for age and sex in children\n\nExclusion criteria:\n\n* 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.\n* Weight loss \\>5% in the past 3 months.\n* Initiation of new weight loss program, including diet or medications. If on weight loss medications, must be on a stable dose for \\>3 months.\n* Inability to swallow capsules.\n* History of hypersensitivity to atomoxetine.\n* Narrow angle glaucoma.\n* History of pheochromocytoma.\n* Uncontrolled Stage 2 hypertension (≥95th percentile + 12 mmHg or \\>140\u002F90, whichever is lower) at screening. If on antihypertensive medication, must be on stable dose for \\>3 months.\n* Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \\>3x upper limit of normal)\n* Uncontrolled asthma requiring albuterol more than once weekly over the past 3 months\n* History of a cardiac arrhythmia (not including bradycardia)\n* Current use of monoamine oxidase inhibitors\n* Pregnancy or intention to become pregnant during the next year\n* 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)\n* PHQ-9 score is ≥15 or suicidal ideation of type 4 or 5 (C-SSR) in the past month\n* Unable to comply with study procedures in the opinion of the investigator","ALL","6 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,15],"Melanocortin Obesity Syndrome",[29,30,31,32,33,34],"Obesity","BDNF","MC4R","Atomoxetine","Energy balance","Weight loss","RECRUITING","2026-08-04",{"date":38,"type":39},"2026-08-07","ACTUAL",{"date":41,"type":21},"2026-09-01",{"date":43,"type":21},"2028-06",{"name":45,"class":46},"Icahn School of Medicine at Mount Sinai","OTHER",3]