[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652253":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":41,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":26,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":26},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide","EXPERIMENTAL","Drug: Semaglutide - oral tablet 3 mg once daily in the morning (titrated up from a low starting dose over 5 days), added to ongoing second-generation antipsychotic (TAU), for 24 weeks.",[13],"Drug: Semaglutide + TAU",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Drug: Placebo - matching oral tablet once daily in the morning, added to ongoing second-generation antipsychotic (TAU), for 24 weeks.",[19],"Drug: Placebo + TAU",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Semaglutide + TAU","Semaglutide - oral tablet 3 mg once daily in the morning (titrated up from a low starting dose over 5 days), added to ongoing second-generation antipsychotic (TAU), for 24 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo + TAU","Placebo - matching oral tablet once daily in the morning, added to ongoing second-generation antipsychotic (TAU), for 24 weeks",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Debadatta Mohapatra, MD","CONTACT","+91 9437658251","psych_debadatta@aiimsbhubaneswar.edu.in",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dr. Debadatta Mohapatra","Associate Professor",[42],{"name":43,"class":44},"Indian Council of Medical Research","OTHER_GOV","100652253","phase-3-efficacy-and-safety-of-semaglutide-versus-placebo-on-cardiometabolic-profile-in-patients-with-schizophrenia-with-metabolic-syndrome-100652253",false,"NCT07770282","Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome","Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome: A Multicentre, Double-Blind, Randomised Controlled Trial (ESCaMS Trial)","Inclusion Criteria:\n\n* Clinically diagnosed schizophrenia (ICD-11) on a second-generation antipsychotic (SGA) for more than 6 months.\n\n  * Metabolic syndrome per NCEP ATP III definition.\n  * Aged above 25 years, any gender.\n  * Patient \u002F Legally Authorised Representative (LAR) provides voluntary written informed consent.\n\nExclusion Criteria:\n\n* ● On clozapine, aripiprazole, or a combination of SGAs.\n\n  * Any contraindication to semaglutide.\n  * Comorbid severe psychiatric, medical or neurological disorder.\n  * History of organicity or significant head injury.\n  * Pregnant or breastfeeding.",true,"ALL","18 Years","60 Years",{"count":57,"type":58},600,"ESTIMATED","INTERVENTIONAL",[61],"PHASE3","Patients with schizophrenia on second-generation antipsychotics have a high burden of metabolic syndrome and elevated cardiovascular risk, with few effective treatment options. This multicentre, double-blind, placebo-controlled randomised trial evaluates whether adjunctive oral semaglutide 3 mg once daily, added to treatment as usual, reduces 10-year cardiovascular risk (QRISK3) and improves insulin resistance, lipids, weight and metabolic biomarkers over 24 weeks compared with placebo, while confirming psychiatric safety and tolerability.",[64,65,66,67,68],"Schizophrenia Disorder","Metabolic Syndrome","Antipsychotic-induced Weight Gain","Cardiovascular Risk","Insulin Resistance",[9,70,71,72,73],"Metabolic syndrome","QRISK3","Cardiometabolic risk","Schizophrenia","NOT_YET_RECRUITING","2026-08-13",{"date":77,"type":78},"2026-08-18","ACTUAL",{"date":80,"type":58},"2026-12-01",{"date":82,"type":58},"2030-12-30",{"name":5,"class":6}]