[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638671":3},{"organization":4,"outcomesModule":7,"designInfo":87,"detailedDescription":93,"studyPopulation":11,"armGroups":94,"interventions":106,"overallOfficials":116,"centralContacts":121,"locations":127,"responsibleParty":142,"collaborators":146,"id":150,"slug":11,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":151,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":11,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":129,"whyStopped":11,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Tri-Service General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Percent change in total body weight from baseline to 6 months.",null,"Baseline to 6 months",{"measure":14,"description":11,"timeFrame":12},"Total fat to lean mass loss ratio (DXA derived) from baseline to 6 months.",{"measure":16,"description":11,"timeFrame":17},"Change in metabolic syndrome severity Z score from baseline to 6 months.","Baseline to 6 months.",[19,22,25,27,29,31,33,35,37,39,42,45,47,49,51,53,55,57,59,61,63,65,67,69,71,73,75,78,81,84],{"measure":20,"description":11,"timeFrame":21},"Change in waist circumference (cm)","Baseline to 6 months and 12 months",{"measure":23,"description":11,"timeFrame":24},"Change in waist-to-hip ratio (unitless ratio)","Baseline to 6 months and 12 months.",{"measure":26,"description":11,"timeFrame":24},"Change in regional fat mass measured by DXA (grams)",{"measure":28,"description":11,"timeFrame":21},"Change in regional lean mass measured by DXA (grams)",{"measure":30,"description":11,"timeFrame":24},"Change in 7-site skinfold thickness (mm)",{"measure":32,"description":11,"timeFrame":21},"Change in liver fat content measured by MRI-PDFF (percentage, %PDFF)",{"measure":34,"description":11,"timeFrame":21},"Change in abdominal visceral fat volume (mL)",{"measure":36,"description":11,"timeFrame":21},"Change in abdominal subcutaneous fat volume (mL)",{"measure":38,"description":11,"timeFrame":21},"Change in systolic and diastolic blood pressure (mmHg)",{"measure":40,"description":41,"timeFrame":21},"Change in fasting lipid profile (mg\u002FdL)","Lipid profile includes total cholesterol, LDL-C, HDL-C and Triglycerides",{"measure":43,"description":11,"timeFrame":44},"Change in fasting glucose (mg\u002FdL)","Baseline to 6 and 12 months",{"measure":46,"description":11,"timeFrame":44},"Change in hsCRP (mg\u002FL)",{"measure":48,"description":11,"timeFrame":44},"Change in insulin sensitivity (HOMA-IR, unitless)",{"measure":50,"description":11,"timeFrame":44},"Change in β-cell function (HOMA-β, percentage, %)",{"measure":52,"description":11,"timeFrame":44},"Change in AI-ECG predicted ASCVD risk score (percentage, %)",{"measure":54,"description":11,"timeFrame":44},"Change in ECG-derived heart age (years)",{"measure":56,"description":11,"timeFrame":44},"Change in AI-ECG diabetes risk index (HbA1c, percentage, %)",{"measure":58,"description":11,"timeFrame":44},"Change in estimated 10-year ASCVD risk (percentage, %)",{"measure":60,"description":11,"timeFrame":44},"Change in bone mineral density (g\u002Fcm²)",{"measure":62,"description":11,"timeFrame":44},"Change in serum P1NP (ng\u002FmL)",{"measure":64,"description":11,"timeFrame":44},"Change in serum CTX-1 (ng\u002FmL)",{"measure":66,"description":11,"timeFrame":44},"Change in fasting plasma metabolomics profile (relative abundance units)",{"measure":68,"description":11,"timeFrame":44},"Change in fasting plasma proteomics profile (relative abundance units)",{"measure":70,"description":11,"timeFrame":44},"Change in microRNA expression signatures (normalized expression units)",{"measure":72,"description":11,"timeFrame":44},"Change in RNA-seq transcriptomic signatures (normalized counts, e.g., TPM)",{"measure":74,"description":11,"timeFrame":44},"Change in epigenetic methylation signatures (Methylation, percentage, %)",{"measure":76,"description":77,"timeFrame":44},"Change in depressive symptoms (scale score)","Instrument: e.g., PHQ-9",{"measure":79,"description":80,"timeFrame":44},"Change in sleep quality (scale score)","Instrument: e.g., PSQI",{"measure":82,"description":83,"timeFrame":44},"Change in quality of life (scale score)","Instrument: e.g., EQ-5D or SF-36",{"measure":85,"description":11,"timeFrame":86},"Change in eating behavior (WREQ-C total and subscale scores)","Baseline to 3, 6, and 12 months",{"allocation":88,"interventionModel":89,"interventionModelDescription":11,"primaryPurpose":90,"observationalModel":11,"timePerspective":11,"maskingInfo":91},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":92,"maskingDescription":11,"whoMasked":11},"NONE","This study is a single-center, randomized, open-label, active-comparator trial designed to characterize the differential effects of tirzepatide and semaglutide on adipose tissue biology and cardiometabolic remodeling over 12 months in adults with obesity and metabolic syndrome. The trial integrates pharmacologic weight-loss therapy with multimodal phenotyping to quantify changes across body composition, hepatic steatosis, metabolic biomarkers, functional strength, and AI-derived electrophysiologic signatures.\n\nThe scientific premise is that incretin-based therapies may produce qualitatively distinct patterns of fat loss, ectopic fat mobilization, and cardiometabolic improvement. Tirzepatide, a dual GIP\u002FGLP-1 receptor agonist, may induce greater reductions in visceral adiposity and hepatic fat compared with GLP-1 receptor agonism alone. This trial is designed to directly compare these mechanistic profiles using harmonized imaging, biochemical, and digital phenotyping platforms.\n\nParticipants are randomized 1:1 to tirzepatide or semaglutide using a computer-generated permuted block scheme stratified by sex and baseline BMI category. Both interventions follow standard titration schedules and are paired with structured lifestyle counseling to ensure comparable background care. Study visits occur at baseline, 3, 6, and 12 months, with deep phenotyping at baseline, 6, and 12 months.\n\nThe phenotyping framework emphasizes regional adiposity, lean mass preservation, hepatic steatosis, and cardiometabolic risk signatures. Whole-body DXA provides quantification of total and regional fat and lean mass, enabling derivation of fat-to-lean mass loss ratios and redistribution indices. Abdominal MRI with proton density fat fraction (PDFF) quantifies liver fat content and abdominal fat compartments. Functional and behavioral assessments-including grip strength and the Chinese version of the Weight-Related Eating Questionnaire-characterize changes in physical function and eating behavior patterns over time.\n\nFasting biochemical panels measure glycemic indices, lipid metabolism, inflammation, renal and hepatic function, and cardiometabolic biomarkers. Standard 12-lead ECGs are processed through a validated AI pipeline to generate electrophysiologic risk features (e.g., predicted ASCVD risk, ECG-derived heart age), which serve as exploratory digital biomarkers.\n\nA centralized biobanking program supports mechanistic analyses. Serum, plasma, and PBMCs collected at each deep-phenotyping visit are stored under standardized SOPs for targeted and discovery-based metabolomic, proteomic, epigenetic and transcriptomic analyses. These biospecimens will enable downstream investigation of molecular pathways underlying differential treatment responses.\n\nTogether, this integrated platform allows for a comprehensive comparison of tirzepatide and semaglutide across structural, metabolic, functional, and molecular domains, providing mechanistic insight into how incretin-based therapies remodel adipose tissue and cardiometabolic physiology.",[95,101],{"label":96,"type":97,"description":98,"interventionNames":99},"Tirzepatide arm","ACTIVE_COMPARATOR","starting at 2.5 mg weekly and escalated every month (5.0 mg, 7.5 mg to 10 mg) as tolerated",[100],"Drug: Tirzepatide with lifestyle modification",{"label":102,"type":97,"description":103,"interventionNames":104},"Semaglutide arm","starting at 0.25 mg weekly and escalated every month (0.5 mg, 1.0 mg, 1.7 mg to 2.4 mg) as tolerated",[105],"Drug: Semaglutide with lifestyle modification",[107,112],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":11},"DRUG","Tirzepatide with lifestyle modification","Starting at Tirzepatide 2.5 mg weekly and escalated as tolerated to 10 mg along with standardized lifestyle counseling by a dietitian (caloric deficit, physical activity guidance) and written materials.",[96],{"type":108,"name":113,"description":114,"armGroupLabels":115,"otherNames":11},"Semaglutide with lifestyle modification","Starting at Semaglutide 0.25 mg weekly and escalated as tolerated to 2.4 mg along with standardized lifestyle counseling by a dietitian (caloric deficit, physical activity guidance) and written materials.",[102],[117],{"name":118,"affiliation":119,"role":120},"Feng-Chih Kuo, M.D., Ph.D.","Division of Endocrinology and Metabolism, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical University, Taipei, Taiwan.","STUDY_DIRECTOR",[122],{"name":118,"role":123,"phone":124,"phoneExt":125,"email":126},"CONTACT","886-2-87923311","12687","shoummie@hotmail.com",[128],{"facility":5,"status":129,"city":130,"state":11,"zip":131,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":139,"contacts":140},"RECRUITING","Taipei","114202","Taiwan","TW",{"type":135,"coordinates":136},"Point",[137,138],121.52639,25.05306,{"lat":138,"lon":137},[141],{"name":118,"role":123,"phone":124,"phoneExt":125,"email":126},{"type":143,"investigatorFullName":144,"investigatorTitle":145,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Feng-Chih Kuo","Director, Head of the Division of Endocrinology and Metabolism, Principal Investigator, Associate Professor",[147],{"name":148,"class":149},"National Science and Technology Council, Taiwan","OTHER_GOV","100638671",false,"NCT07589322","Comparative Observation of Metabolic and Pharmacologic Adipose Remodeling With Enhanced Incretin AgonisTs","Comparative Adipose Tissue and Cardiometabolic System Remodeling by Tirzepatide and Semaglutide: an AI-integrated Multimodal Metabolomics and Translational Mechanistic Study","COMPARE-AT","Inclusion Criteria:\n\n* Age 20-65 years.\n* BMI ≥27 kg\u002Fm² with metabolic syndrome (ATP III or IDF criteria).\n* Stable background medications (antihypertensives, statins, etc.) for ≥3 months.\n* Able and willing to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* History of diabetes; history of pancreatitis; personal\u002Ffamily history of medullary thyroid carcinoma or MEN2.\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m², decompensated liver disease, NYHA class III-IV heart failure.\n* Recent (\\\u003C3 months) acute coronary syndrome, stroke, or coronary revascularization.\n* Current use of GLP 1RA, tirzepatide, or other incretin based therapies within 3 months.\n* Contraindications to MRI or DXA (e.g., metal implants incompatible with MRI, pregnancy).","ALL","20 Years","65 Years",{"count":161,"type":162},120,"ESTIMATED","INTERVENTIONAL",[165],"NA","This randomized, open label, head to head clinical trial directly compares tirzepatide and semaglutide in adults with obesity and metabolic syndrome (N=120, age 20-65, 1:1 randomization). Participants undergo deep phenotyping at baseline, 6 months, and 12 months, including DXA (regional fat, lean mass, and BMD), MRI PDFF (liver fat), 7 site skinfold thickness, grip strength, fasting biochemistry, and AI processed 12 lead ECGs. Centralized biobanking of serum, plasma, and PBMCs enables targeted and discovery multi omic analyses.",[168],"Obesity and Metabolic Syndrome",[170,171,172,173,174],"tirzepatide","semaglutide","obesity","metabolic syndrome","multi omic","2026-05-10",{"date":177,"type":178},"2026-05-15","ACTUAL",{"date":180,"type":178},"2026-03-31",{"date":182,"type":162},"2029-09-30",{"name":5,"class":6},1]