[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655256":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":61,"studyPopulation":62,"armGroups":63,"interventions":58,"overallOfficials":73,"centralContacts":81,"locations":90,"responsibleParty":180,"collaborators":182,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":188,"sex":194,"minAge":195,"maxAge":58,"enrollmentInfo":196,"targetDuration":45,"studyType":199,"phases":58,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":211,"whyStopped":58,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"Universiti Sains Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage change in body weight (obesity and prediabetes cohorts)","Mean percentage change in body weight from baseline to Week 26 in the combined obesity and prediabetes cohorts, analysed using a mixed model for repeated measures.","Baseline to Week 26",{"measure":14,"description":15,"timeFrame":12},"Change in HbA1c (type 2 diabetes cohort)","Mean change in glycated haemoglobin (HbA1c) from baseline to Week 24 in the type 2 diabetes with obesity cohort, analysed using a mixed model for repeated measures.",[17,20,23,26,29],{"measure":18,"description":19,"timeFrame":12},"Change in BMI","Mean change in body mass index (BMI) from baseline to Week 26.",{"measure":21,"description":22,"timeFrame":12},"Change in waist circumference","Mean change in waist circumference (cm) from baseline to Week 26",{"measure":24,"description":25,"timeFrame":12},"Change in blood pressure","Mean change in systolic and diastolic blood pressure from baseline to Week 26.",{"measure":27,"description":28,"timeFrame":12},"Change in lipid profile","Mean change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides from baseline to Week 26",{"measure":30,"description":31,"timeFrame":12},"Treatment persistence","Proportion of participants persisting on tirzepatide, and time to discontinuation, over 26 weeks.",[33,36,39,42,46,49,53],{"measure":34,"description":35,"timeFrame":12},"Adverse events and serious adverse events","Incidence, type, and severity of adverse events and serious adverse events over 26 weeks.",{"measure":37,"description":38,"timeFrame":12},"Medication adherence","Change in medication adherence, measured by the 8-item Morisky Medication Adherence Scale (MMAS-8), from baseline to Week 26. 8-item Morisky Medication Adherence Scale (MMAS-8); scores range 0 to 8, higher scores indicate better adherence.",{"measure":40,"description":41,"timeFrame":12},"Change in health-related quality of life (SF-36v2)","Mean change in the 36-Item Short Form Health Survey version 2 (SF-36v2) score from baseline to Week 24, in all cohorts. Scores range from 0 to 100; higher scores indicate better health-related quality of life.",{"measure":43,"description":44,"timeFrame":45},"Change in weight-related quality of life (OWLQOL)","Mean change in the Obesity and Weight-Loss Quality of Life (OWLQOL) questionnaire score from baseline to Week 26, in the obesity and prediabetes cohorts. Higher scores indicate better weight-related quality of life.","26 Weeks",{"measure":47,"description":48,"timeFrame":45},"Change in eating behaviour and appetite (EBAQ)","Mean change in the Eating Behaviour and Appetite Questionnaire (EBAQ) score from baseline to Week 26, in the obesity and prediabetes cohorts.",{"measure":50,"description":51,"timeFrame":52},"Change in diabetes treatment satisfaction (DTSQs)","Mean change in the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs), from baseline to Week 26, in the type 2 diabetes and treated prediabetes participants. Higher scores indicate greater treatment satisfaction.","Week 26",{"measure":54,"description":55,"timeFrame":56},"Diabetes treatment satisfaction, change version (DTSQc)","Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), measured at the interim and final visits in the type 2 diabetes and treated prediabetes participants. Higher scores indicate improved treatment satisfaction relative to previous treatment. Not administered at baseline.","Week 30",{"allocation":58,"interventionModel":58,"interventionModelDescription":58,"primaryPurpose":58,"observationalModel":59,"timePerspective":60,"maskingInfo":58},null,"COHORT","PROSPECTIVE","Tirzepatide's pivotal trials enrolled very few South Asian participants and no Pakistani sites, while Pakistan carries one of the world's highest diabetes burdens. This study provides real-world effectiveness, safety, and patient-reported outcome data from Pakistani routine care to address that gap.","Adults aged 18 years or older with obesity (BMI ≥ 30) who are initiating tirzepatide as part of routine clinical care at ten diabetes and endocrinology centres in Pakistan. Participants are grouped into three cohorts by glycaemic status at entry: obesity without diabetes (HbA1c \\\u003C 5.7%), prediabetes with obesity (HbA1c 5.7-6.4%), and type 2 diabetes with obesity (diagnosed at least 6 months prior).",[64,67,70],{"label":65,"type":58,"description":66,"interventionNames":58},"Obesity without diabetes","Adults with obesity (BMI ≥ 30) and normoglycaemia (HbA1c \\\u003C 5.7%), with no diabetes diagnosis, initiating tirzepatide in routine clinical care. Followed for weight and metabolic outcomes over 26 weeks.",{"label":68,"type":58,"description":69,"interventionNames":58},"Prediabetes with obesity","Adults with obesity (BMI ≥ 30) and prediabetes (HbA1c 5.7-6.4%), initiating tirzepatide in routine clinical care. Followed for weight and metabolic outcomes over 26 weeks.",{"label":71,"type":58,"description":72,"interventionNames":58},"Type 2 diabetes with obesity","Adults with obesity (BMI ≥ 30) and type 2 diabetes mellitus diagnosed at least 6 months prior, initiating tirzepatide in routine clinical care. Followed for change in glycaemic control (HbA1c) over 26 weeks.",[74,77],{"name":75,"affiliation":5,"role":76},"Muhammad Daoud Butt, PhD","PRINCIPAL_INVESTIGATOR",{"name":78,"affiliation":79,"role":80},"Abdul Basit, MBBS","Indus Hospital Health Network","STUDY_CHAIR",[82,87],{"name":83,"role":84,"phone":85,"phoneExt":58,"email":86},"Dr Quanita Tayyab, MBBS","CONTACT","+92 331 5119873","quanitatayyab10@gmail.com",{"name":75,"role":84,"phone":88,"phoneExt":58,"email":89},"+60-16-7054015","daoudbutt@usm.my",[91,106,117,128,138,148,159,168,175],{"facility":92,"status":58,"city":93,"state":94,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Bolan Medical Complex","Quetta","Balouchistan","Pakistan","PK",{"type":98,"coordinates":99},"Point",[100,101],67.00141,30.18414,{"lat":101,"lon":100},[104],{"name":105,"role":84,"phone":85,"phoneExt":58,"email":86},"Quanita Tayyab, MBBS",{"facility":107,"status":58,"city":108,"state":109,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Khyber Medical University","Peshawar","KPK",{"type":98,"coordinates":111},[112,113],71.57849,34.008,{"lat":113,"lon":112},[116],{"name":105,"role":84,"phone":85,"phoneExt":58,"email":86},{"facility":118,"status":58,"city":119,"state":120,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Capital Development Authority (CDA) Hospital","Islamabad","Punjab Province",{"type":98,"coordinates":122},[123,124],72.92417,32.24639,{"lat":124,"lon":123},[127],{"name":105,"role":84,"phone":85,"phoneExt":58,"email":86},{"facility":129,"status":58,"city":130,"state":120,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Jinnah Postgraduate Medical Centre","Lahore",{"type":98,"coordinates":132},[133,134],74.35071,31.558,{"lat":134,"lon":133},[137],{"name":105,"role":84,"phone":85,"phoneExt":58,"email":86},{"facility":139,"status":58,"city":140,"state":120,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hanif Medical Complex","Rawalpindi",{"type":98,"coordinates":142},[143,144],73.0479,33.59733,{"lat":144,"lon":143},[147],{"name":105,"role":84,"phone":85,"phoneExt":58,"email":86},{"facility":149,"status":58,"city":150,"state":151,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Aga Khan University Hospital (AKUH)","Karachi","Sindh",{"type":98,"coordinates":153},[154,155],67.0104,24.8608,{"lat":155,"lon":154},[158],{"name":105,"role":84,"phone":85,"phoneExt":58,"email":86},{"facility":79,"status":58,"city":150,"state":151,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":160,"geoPoint":162,"contacts":163},{"type":98,"coordinates":161},[154,155],{"lat":155,"lon":154},[164],{"name":165,"role":84,"phone":166,"phoneExt":58,"email":167},"Muhammad Daoud Butt","03215150497","muhammaddaoud10@yahoo.com",{"facility":169,"status":58,"city":150,"state":151,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":170,"geoPoint":172,"contacts":173},"OMI Hospital",{"type":98,"coordinates":171},[154,155],{"lat":155,"lon":154},[174],{"name":105,"role":84,"phone":85,"phoneExt":58,"email":86},{"facility":176,"status":58,"city":177,"state":151,"zip":58,"country":95,"countryCode":96,"cosmosGeoPoint":58,"geoPoint":58,"contacts":178},"Chandka Medical College","Lārkāna",[179],{"name":105,"role":84,"phone":85,"phoneExt":58,"email":86},{"type":76,"investigatorFullName":165,"investigatorTitle":181,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"Dr",[183],{"name":184,"class":185},"BF Biosciences Pvt Ltd","UNKNOWN","100655256","real-world-outcomes-of-tirzepatide-in-pakistani-adults-with-obesity-prediabetes-and-type-2-diabetes-100655256",false,"NCT07809568","Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes","Real-World Effectiveness, Safety, and Patient-Reported Outcomes of Tirzepatide in Adults With Type 2 Diabetes Mellitus, Obesity, or Prediabetes in Pakistan: A Multicentre, Prospective, Observational Cohort Study","TRIBUTE-PK","Inclusion Criteria:\n\n* Adult aged 18 years or older\n* Obesity (BMI ≥ 30) meeting one cohort definition\n* Baseline HbA1c available to confirm cohort\n* Initiating tirzepatide as part of routine clinical care, decided independently of the study\n* No prior lifetime use of tirzepatide\n* Washout of at least 8 weeks from any GLP-1 or dual GIP\u002FGLP-1 receptor agonist, if previously used\n* Baseline retinal (eye) screening completed\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Type 1 or secondary diabetes\n* Any prior tirzepatide use\n* Proliferative diabetic retinopathy or clinically significant macular oedema\n* Pregnancy or breastfeeding\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* Active malignancy, or a major cardiovascular event within the past 3 months\n* Inability to undergo retinal assessment\n* Mental incapacity or language barrier preventing informed consent","ALL","18 Years",{"count":197,"type":198},330,"ESTIMATED","OBSERVATIONAL","This is a multicentre, prospective, observational study of the medicine tirzepatide as it is used in routine clinical care in Pakistan. Tirzepatide is already approved for type 2 diabetes and for obesity, but there is very little information on how it works for people in South Asia, and none from Pakistan specifically. This study aims to fill that gap.\n\nThe study will follow 330 adults who are starting tirzepatide as part of their normal treatment, across ten diabetes and endocrinology centres in Pakistan. Everyone taking part has obesity, and they are grouped into three cohorts based on their blood sugar status at the start: obesity without diabetes, prediabetes with obesity, and type 2 diabetes with obesity.\n\nThe study does not change anyone's treatment. The treating doctor decides whether to prescribe tirzepatide, at what dose, and for how long. The study simply observes and records what happens over 24 weeks, with assessments at the start, at Weeks 12 to 14, and at Weeks 24 to 26.\n\nThe main things measured are the change in blood sugar control (HbA1c) in the diabetes cohort, and the change in body weight in the obesity and prediabetes cohorts. The study also looks at changes in blood pressure, cholesterol, and other measures, how well people stay on treatment, any side effects, and how participants feel about their treatment and quality of life. The findings will help doctors understand how tirzepatide performs in real-world care in Pakistan and inform its use in similar populations.",[202,203,204],"Prediabetes or Overweight","Obesity Type 2 Diabetes Mellitus","Obesity & Overweight",[206,207,208,209,210,95],"Tirzepetide","Type 2 Diabetes","Obesity","Real-world evidence","South Asia","NOT_YET_RECRUITING","2026-09-02",{"date":214,"type":215},"2026-09-09","ACTUAL",{"date":217,"type":198},"2026-10-01",{"date":219,"type":198},"2028-03-31",{"name":5,"class":6},9]