[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574535":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":158,"collaborators":31,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":31,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":31,"enrollmentInfo":169,"targetDuration":31,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":183,"overallStatus":47,"whyStopped":31,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Rhythm Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Setemelanotide","EXPERIMENTAL","Randomized 2:1 (Setmelanotide: Placebo)",[13],"Drug: 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Philadelphia","Philadelphia","Pennsylvania","19104",{"type":54,"coordinates":114},[115,116],-75.16362,39.95238,{"lat":116,"lon":115},{"facility":119,"status":47,"city":120,"state":121,"zip":122,"country":51,"countryCode":52,"cosmosGeoPoint":123,"geoPoint":127,"contacts":31},"Seattle Children's Research Institute","Seattle","Washington","98105",{"type":54,"coordinates":124},[125,126],-122.33207,47.60621,{"lat":126,"lon":125},{"facility":129,"status":47,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":139,"contacts":31},"UCL Great Ormond Street Institute of Child Health","London","Greater London","WC1N 1EH","United Kingdom","UK",{"type":54,"coordinates":136},[137,138],-0.12574,51.50853,{"lat":138,"lon":137},{"facility":141,"status":47,"city":48,"state":142,"zip":143,"country":133,"countryCode":134,"cosmosGeoPoint":144,"geoPoint":148,"contacts":31},"Birmingham Women and Children's Hospital NHS Trust","West Midlands","B46NH",{"type":54,"coordinates":145},[146,147],-1.89983,52.48142,{"lat":147,"lon":146},{"facility":150,"status":47,"city":151,"state":31,"zip":152,"country":133,"countryCode":134,"cosmosGeoPoint":153,"geoPoint":157,"contacts":31},"Hull Royal Infirmary","Hull","HU32RW",{"type":54,"coordinates":154},[155,156],-0.33525,53.7446,{"lat":156,"lon":155},{"type":159,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100574535","phase-3-a-trial-of-setmelanotide-in-patients-with-congenital-hypothalamic-obesity-sub-study-of-nct05774756-100574535",false,"NCT06760546","A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)","A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity","Key Inclusion Criteria:\n\n1. Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dysplasia (SOD), or optic nerve hypoplasia (ONH), or Childhood-onset combined pituitary hormone deficiency (CPHD), or Pituitary Stalk Interruption Syndrome (PSIS) with at least one pituitary deficiency AND a body mass index (BMI) of ≥30 kg\u002Fm2 for patients ≥18 years of age, or BMI ≥95th percentile for age and sex for patients 4 to \\\u003C18 years\n2. Age 4 years and older\n3. Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg\u002Fm2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to \\\u003C18 years of age\n4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study\n\nKey Exclusion Criteria:\n\n1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)\n2. Weight loss \\>2% in the previous 3 months for patients aged ≥18 years or \\>2% reduction in BMI for patients aged 4 to \\\u003C18 years\n3. Bariatric surgery or procedure within last 2 years\n4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior\n5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease\n6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)\n7. History or close family history of skin cancer or melanoma\n8. Participation in any clinical trial with an investigational drug\u002Fdevice within 3 months prior to the first trial dose\n9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide\n10. Inability to comply with once daily (QD) injection regimen\n11. If female, pregnant and\u002For breastfeeding.\n12. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","4 Years",{"count":170,"type":171},39,"ESTIMATED","INTERVENTIONAL",[174],"PHASE3","This is a sub-study of Study RM-493-040 (NCT05774756).\n\nThe goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.",[177,178,179,180,181,182],"Hypothalamic Obesity","Multiple Pituitary Hormone Deficiency Genetic Form","Septo-Optic Dysplasia","Optic Nerve Hypoplasia","Childhood-onset Combined Pituitary Hormone Deficiency","Pituitary Stalk Interruption Syndrome",[184],"melancortin 4 receptor, MC4R","2026-02-10",{"date":187,"type":188},"2026-02-12","ACTUAL",{"date":190,"type":188},"2025-09-23",{"date":192,"type":171},"2028-03-13",{"name":5,"class":6},11]