[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600611":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":101,"collaborators":10,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":10,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":10,"enrollmentInfo":114,"targetDuration":10,"studyType":117,"phases":10,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":123,"whyStopped":10,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Beximco Pharmaceuticals Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirzepatide Group",null,"Participants in this group will receive subcutaneous Tirzepatide administered once weekly at a dose determined by standard clinical practice. The dose may be titrated based on patient tolerability and glycemic response.",[13],"Drug: Tirzepatide",{"label":15,"type":10,"description":16,"interventionNames":17},"Lifestyle Modification Group","Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.",[18],"Behavioral: Life Style Modification",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DRUG","Tirzepatide","Exposure",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"BEHAVIORAL","Life Style Modification","Referent group - Lifestyle interventions, exercise, and diet control",[15],[31],{"name":32,"affiliation":33,"role":34},"Prof. Dr. Indrajit Prasad, MBBS, MD(Endo)","Dhaka Medical College Hospital, Dhaka","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":10,"email":39},"CONTACT","+8801729094980","drindrajit1976@yahoo.com",{"name":41,"role":37,"phone":10,"phoneExt":10,"email":42},"Prof. Dr. A.H.M Akhtaruzzaman, MBBS, MCPS, MD(Endo)","akter1974@gmail.com",[44,63,83],{"facility":45,"status":10,"city":46,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Trauma Centre, Cumilla.","Comilla","Bangladesh","BD",{"type":50,"coordinates":51},"Point",[52,53],91.18503,23.46186,{"lat":53,"lon":52},[56,60],{"name":57,"role":37,"phone":58,"phoneExt":10,"email":59},"Prof. Dr. Ajit Kumar Paul, MBBS, MD(Endo)","+8801713409655","ajitendo@gmail.com",{"name":61,"role":62,"phone":10,"phoneExt":10,"email":10},"Prof. Dr. Ajit Kumar Paul","SUB_INVESTIGATOR",{"facility":33,"status":10,"city":64,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Dhaka",{"type":50,"coordinates":66},[67,68],90.40744,23.7104,{"lat":68,"lon":67},[71,73,76,77,79,81],{"name":72,"role":37,"phone":38,"phoneExt":10,"email":39},"Prof. Dr. Indrajit Prasad",{"name":74,"role":37,"phone":10,"phoneExt":10,"email":75},"Dr. M Saifuddin, MBBS, MD(Endo)","saifk56dmc@yahoo.com",{"name":72,"role":34,"phone":10,"phoneExt":10,"email":10},{"name":78,"role":62,"phone":10,"phoneExt":10,"email":10},"Dr. M Saifuddin",{"name":80,"role":62,"phone":10,"phoneExt":10,"email":10},"Dr. Mirza Sharifuzzaman",{"name":82,"role":62,"phone":10,"phoneExt":10,"email":10},"Dr. Moinul Islam",{"facility":84,"status":10,"city":85,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Rajshahi Medical College Hospital, Rajshahi","Rajshahi",{"type":50,"coordinates":87},[88,89],88.60114,24.374,{"lat":89,"lon":88},[92,94,97,99],{"name":41,"role":37,"phone":93,"phoneExt":10,"email":42},"+8801748389609",{"name":95,"role":37,"phone":10,"phoneExt":10,"email":96},"Dr. Masud Un Nabi, MBBS, MD(Endo)","masudnabi@gmail.com",{"name":98,"role":62,"phone":10,"phoneExt":10,"email":10},"Prof. Dr. A.H.M Akhtaruzzaman",{"name":100,"role":62,"phone":10,"phoneExt":10,"email":10},"Dr. Masud Un Nabi",{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Dr. Md. Alimur Reza","Study Epidemiologist","100600611","effectiveness-and-safety-of-tirzepatide-among-participants-with-obesity-with-or-without-type-2-diabetes-mellitus-t2dm-100600611",false,"NCT07099742","Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)","A Study of Real-World Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM) in Bangladesh","Inclusion Criteria:\n\n* Adult patients of both sexes, aged ≥18 years.\n* Body mass index (BMI) ≥25 kg\u002Fm².\n* Naïve to glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy.\n* Self-reported stable body weight (change ≤5 kg) over the past 3 months.\n\nExclusion Criteria:\n\n* Diagnosis of diabetes other than Type 2 Diabetes Mellitus.\n* History of chronic or acute pancreatitis.\n* Presence of acute medical conditions, including acute hepatitis, myocardial infarction, stroke, heart failure, febrile illness, or acute diarrheal disease.\n* Evidence of significant, uncontrolled endocrine disorders (e.g., Cushing's syndrome, thyroid disorders, adrenal insufficiency, congenital adrenal hyperplasia).\n* History or presence of malignancy.\n* Active gallbladder disease.\n* Female participants who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential, not using adequate contraceptive methods.\n* Prior or planned surgical treatment for obesity.\n* Use of weight-loss products (including prescription medications, over-the-counter drugs, or herbal preparations) within 3 months prior to screening.","ALL","18 Years",{"count":115,"type":116},364,"ESTIMATED","OBSERVATIONAL","This is a prospective, multicenter, real-world study conducted in Bangladesh to assess the effectiveness and safety of Tirzepatide compared to structured lifestyle interventions, including dietary modifications and exercise, in obese adults with or without Type 2 Diabetes Mellitus (T2DM).\n\nThe study aims to determine whether treatment with Tirzepatide results in superior weight reduction outcomes compared to lifestyle-based approaches. Adult participants (≥18 years) with a body mass index (BMI) ≥25 kg\u002Fm² and no prior exposure to GLP-1 receptor agonists will be enrolled at the discretion of the treating physician. Eligible participants will receive either once-weekly Tirzepatide or participate in lifestyle intervention programs aligned with standard clinical care.",[120],"Obesity",[22,120,122],"T2DM","NOT_YET_RECRUITING","2025-07-31",{"date":126,"type":127},"2025-08-03","ACTUAL",{"date":129,"type":116},"2025-09",{"date":131,"type":116},"2026-07",{"name":103,"class":6},3]