[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652277":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide + Autism Spectrum Disorder (ASD)-Tailored Lifestyle Management","ACTIVE_COMPARATOR","Participants aged 12-18 years with autism spectrum disorder (ASD) and obesity will receive semaglutide in combination with ASD-tailored lifestyle management (LSM) counseling for 12 months.",[13,14],"Drug: Glucagon-like peptide-1 receptor agonist：Semaglutide","Behavioral: Lifestyle Management (LSM) Counseling",{"label":16,"type":6,"description":17,"interventionNames":18},"Historical Control: ASD-Tailored Lifestyle Management Alone","Historical Control - Retrospectively selected historical controls with ASD and obesity who previously received ASD-tailored lifestyle management (LSM) counseling without semaglutide.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Glucagon-like peptide-1 receptor agonist：Semaglutide","Semaglutide may be increased every 1-3 months from 0.25 mg to 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg, based on the provider's assessment, BIA results (i.e., if SMM remained stable, \\\u003C2 pounds\u002Fweek lost), and side effects.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"BEHAVIORAL","Lifestyle Management (LSM) Counseling","Participants received lifestyle management counseling consisting of education and guidance on nutrition, physical activity, caloric intake, behavioral modification, and weight-management strategies. Counseling was provided as part of standard clinical care without the addition of pharmacologic or investigational interventions.",[16,9],[32],{"name":33,"affiliation":5,"role":34},"Melinda Mahabee-Gittens, MD, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Mary Banks","CONTACT","513-803-3123","mary.banks@cchmc.org",[42],{"facility":43,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45245","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-84.51439,39.12711,{"lat":53,"lon":52},[56,57],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":33,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100652277","phase-4-semaglutide-in-youth-with-autism-spectrum-disorder-100652277",false,"NCT07770152","Semaglutide in Youth With Autism Spectrum Disorder","Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)","GLP1","Inclusion Criteria (Semaglutide Group):\n\n* 12-18 years of age\n* Epic-confirmed diagnosis of ASD\n* Obesity defined as BMI ≥95th percentile for age and sex\n* Have Medicaid or other insurance that will cover semaglutide or the parent is willing to pay for semaglutide out of pocket\n* Have a parent who is willing to provide informed consent\n* Can attend in-person, e-visits, or telehealth visits for 12 months\n* English speaking\n\nExclusion Criteria (Semaglutide Group):\n\n* Healthworks patient who has lost \\>5% body weight over the past 3 months\n* Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months\n* Have Type 1 or Type 2 diabetes\n* Have a personal or first-degree family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia 2\n* Have been on GLP-1 RAs in the past 12 months\n* Have significant GI conditions (e.g., pancreatitis),\n* Are pregnant or breastfeeding\n* Have catatonia or a condition that may affect compliance and safety\n\nInclusion Criteria (Historical Control Group):\n\n* Healthworks patients treated between January 1, 2021-December 31, 2025\n* 12-18 years of age\n* Confirmed diagnosis of ASD\n* Have obesity defined as BMI ≥95th percentile for age and sex\n* Have BMI and SMM outcomes assessed at M0, M6, or M12\n* Age groups 12-14 years old and 15-18 years old and sex matched to youth in the semaglutide group","ALL","12 Years","18 Years",{"count":72,"type":73},42,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","This study is a 6-month, two-arm, RCT which will evaluate the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity. The primary outcome is change in body mass index (BMI, kg\u002Fm²) from baseline to Month 6. Secondary, descriptive outcomes are changes in metabolic parameters (e.g., lipid levels), side effects, and compliance with semaglutide.",[79,80],"Autism Spectrum Disorder","Obesity",[79,80,82],"Semaglutide","NOT_YET_RECRUITING","2026-08-14",{"date":86,"type":87},"2026-08-18","ACTUAL",{"date":89,"type":73},"2026-09-01",{"date":91,"type":73},"2029-09-01",{"name":5,"class":6},1]