[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654850":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":65,"studyPopulation":53,"armGroups":66,"interventions":79,"overallOfficials":93,"centralContacts":97,"locations":103,"responsibleParty":121,"collaborators":53,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":53,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":53,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":148,"whyStopped":53,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Tongji Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage change in Intrapancreatic Fat Deposition (IPFD) from baseline","The relative percentage change in IPFD measured by pancreatic MRI-PDFF at Week 48 compared to baseline, calculated as: \\[(IPFDatWeek48-BaselineIPFD)\u002FBaselineIPFD\\] × 100%.","From baseline to Week 48",[14,17,20,23,26,29,32,35,38,41,44,47,50],{"measure":15,"description":16,"timeFrame":12},"Change in visceral fat area","Absolute change in visceral fat area (measured by MRI or CT, as per protocol specification) from baseline.",{"measure":18,"description":19,"timeFrame":12},"Change in Body Mass Index (BMI)","Absolute change in BMI (kg\u002Fm²) from baseline.",{"measure":21,"description":22,"timeFrame":12},"Change in body weight","Absolute change in body weight (kg) from baseline.",{"measure":24,"description":25,"timeFrame":12},"Change in waist circumference","Absolute change in waist circumference (cm) from baseline.",{"measure":27,"description":28,"timeFrame":12},"Change in basal metabolic rate (BMR)","Absolute change in BMR (kcal\u002Fday) from baseline.",{"measure":30,"description":31,"timeFrame":12},"Changes in complete blood count (CBC) parameters","Evaluation of changes in hematology parameters (e.g., WBC, RBC, Hb, PLT) compared to baseline.",{"measure":33,"description":34,"timeFrame":12},"Changes in liver function tests","Evaluation of changes in ALT, AST, ALP, GGT, total bilirubin, etc., compared to baseline.",{"measure":36,"description":37,"timeFrame":12},"Changes in renal function tests","Evaluation of changes in serum creatinine, BUN, eGFR, etc., compared to baseline.",{"measure":39,"description":40,"timeFrame":12},"Changes in lipid profile","Evaluation of changes in total cholesterol, triglycerides, HDL-C, LDL-C, etc., compared to baseline.",{"measure":42,"description":43,"timeFrame":12},"Changes in pancreatic enzymes (amylase\u002Flipase)","Evaluation of changes in serum amylase and lipase levels compared to baseline.",{"measure":45,"description":46,"timeFrame":12},"Change in glycated hemoglobin (HbA1c)","Absolute change in HbA1c (%) from baseline",{"measure":48,"description":49,"timeFrame":12},"Changes in glucose metabolism indices (OGTT + IRT+CPRT)","Oral glucose tolerance test (OGTT) combined with insulin release test (IRT) and C-peptide release test (CPRT), with blood sampling at fasting state and 30, 60, 90, and 120 minutes post-glucose load.",{"measure":51,"description":52,"timeFrame":12},"Changes in inflammatory markers (IL-6, TNF-α)","Absolute change in serum levels of Interleukin-6 (IL-6) and Tumor Necrosis Factor-alpha (TNF-α) from baseline.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":59,"maskingDescription":53,"whoMasked":60},"QUADRUPLE",[61,62,63,64],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Fatty pancreas is a clinicopathological syndrome characterized by fat infiltration in pancreatic tissue. It can be classified into three categories based on etiology and risk factors: ectopic pancreatic fat deposition due to overnutrition and metabolic dysfunction, secondary fatty replacement following pancreatic injury from various causes, and fatty pancreas associated with genetic or congenital diseases. Among these, excessive fat deposition within pancreatic tissue occurring against the backdrop of metabolic abnormalities is termed metabolic dysfunction-associated fatty pancreas (MAFP), which is commonly seen in individuals with overweight, obesity, or metabolic syndrome. MAFP can impair both endocrine and exocrine pancreatic functions, increase the risks of pancreatitis and glucose metabolism disorders, and significantly elevate the incidence of pancreatic cancer. Currently, there are no approved specific pharmacotherapies for fatty pancreas. Although lifestyle intervention serves as the foundational treatment, long-term patient adherence remains limited. Existing studies suggest that glucagon-like peptide-1 receptor agonists (GLP-1RAs) can effectively reduce visceral and ectopic fat deposition, lowering absolute pancreatic fat content by approximately 2%-6%, thereby demonstrating potential as therapeutic agents for MAFP. Mazdutide, a dual GLP-1 receptor\u002Fglucagon receptor (GLP-1R\u002FGCGR) agonist, synergistically activates dual metabolic pathways, reducing visceral fat accumulation while achieving potent weight loss. Based on its unique mechanism of action and established evidence for weight reduction, mazdutide holds promising application prospects for alleviating MAFP and managing metabolic comorbidities. However, no dedicated studies have yet evaluated the impact of mazdutide on pancreatic fat content in obese patients.",[67,73],{"label":68,"type":69,"description":70,"interventionNames":71},"Intervention group","EXPERIMENTAL","standardized lifestyle intervention + mazdutide",[72],"Drug: mazdutide",{"label":74,"type":75,"description":76,"interventionNames":77},"Control group","PLACEBO_COMPARATOR","standardized lifestyle intervention + placebo",[78],"Other: Placebo matching mazdutide",[80,87],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"DRUG","mazdutide","On the basis of standardized lifestyle intervention, patients received mazdutide injection (prefilled auto-injector pen) via weekly subcutaneous injection (abdominal), following a dose-escalation regimen: an initial dose of 2 mg for weeks 1-4, escalation to 4 mg for weeks 5-8, and a maintenance dose of either 4 mg or 6 mg starting from week 9 (determined by tolerability and efficacy), with a treatment duration of 48 weeks.",[68],[86],"IBI-362; LY3305677",{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"Placebo matching mazdutide","On the basis of standardized lifestyle intervention, patients received a placebo injection identical to mazdutide injection in appearance, volume, and administration route, via weekly subcutaneous injection (abdominal), with a treatment duration of 48 weeks.",[74],[92],"Placebo matching IBI-362",[94],{"name":95,"affiliation":5,"role":96},"Yan Yang","PRINCIPAL_INVESTIGATOR",[98],{"name":99,"role":100,"phone":101,"phoneExt":53,"email":102},"Delin Ma","CONTACT","86-027 83665513","maderine4@163.com",[104],{"facility":105,"status":53,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"TongjHospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430030","China","CN",{"type":112,"coordinates":113},"Point",[114,115],114.26667,30.58333,{"lat":115,"lon":114},[118],{"name":95,"role":100,"phone":119,"phoneExt":53,"email":120},"86-027-83665513","yy2025ywsy@163.com",{"type":96,"investigatorFullName":122,"investigatorTitle":123,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Yan Yang, MD, PhD","Principal Investigator","100654850","efficacy-of-mazdutide-on-fatty-pancreas-100654850",false,"NCT07803705","Efficacy of Mazdutide on Fatty Pancreas","Efficacy of Mazdutide on Fatty Pancreas in Overweight or Obese Adults: A Randomized Controlled Trial","Inclusion Criteria:\n\nPatients participating in this study must meet all of the following criteria:\n\n1. Age 18-60 years (inclusive) at screening, regardless of gender;\n2. BMI at screening meets one of the following conditions: ① BMI ≥28 kg\u002Fm²; or ② 24 kg\u002Fm² ≤ BMI \\\u003C28 kg\u002Fm², with at least one obesity-related metabolic abnormality (elevated fasting blood glucose, dyslipidemia, hypertension, etc.);\n3. Pancreatic MRI-PDFF quantitative assessment completed during the screening period, with intrapancreatic fat deposition (IPFD) ≥6%;\n4. Fully informed about the study and voluntarily signed written informed consent;\n5. Agreed to maintain a stable lifestyle (including diet and exercise habits) during the study.\n\nNote: Diagnostic criteria for Metabolic Syndrome (meeting ≥3 of the following items) \\[ChineseDiabetesSociety(CDS)2020\\]:\n\n1. Abdominal obesity (central obesity): Waist circumference ≥90 cm in men, ≥85 cm in women;\n2. Fasting blood glucose ≥6.1 mmol\u002FL and\u002For 2-hour postprandial blood glucose ≥7.8 mmol\u002FL, and\u002For diagnosed diabetes under treatment;\n3. Blood pressure ≥130\u002F85 mmHg, and\u002For diagnosed hypertension under treatment;\n4. Fasting triglycerides (TG) ≥1.7 mmol\u002FL;\n5. Fasting HDL-C \\\u003C1.04 mmol\u002FL.\n\nExclusion Criteria:\n\nParticipants meeting any of the following conditions will be excluded from this study:\n\nGlycated hemoglobin HbA1c ≥7.5% at screening; history of diabetic ketoacidosis (DKA) or other diabetic emergencies; Use within 3 months before screening of glucagon-like peptide-1 receptor (GLP-1R) agonists, GLP-1R\u002Fglucagon receptor (GCGR) dual agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)\u002FGLP-1R agonists, GIPR\u002FGLP-1R\u002FGCGR triple agonists, insulin, or oral antidiabetic drugs other than metformin; Use of any weight-loss drug or fat-reducing dietary supplement within 1 month before screening\u002Fenrollment; or use within 1 month before screening of systemic medications that may cause weight gain, including systemic glucocorticoids, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers; Self-reported or documented weight fluctuation of \\>5% within 3 months before screening; Current or history of acute pancreatitis or chronic pancreatitis; or serum triglycerides (TG) \\>5.6 mmol\u002FL at screening; or history of acute cholecystitis or symptomatic\u002Frequiring-treatment gallbladder disease (except participants who have undergone cholecystectomy and are judged by the investigator to be eligible); Chronic kidney disease stage 3 or higher, eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² (calculated by CKD-EPI formula); Obesity secondary to other endocrine diseases, such as Cushing syndrome; Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (MTC); History of malignancy within 5 years before screening (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.); Acute myocardial infarction, unstable angina, coronary revascularization, stroke, or transient ischemic attack within 6 months before screening; or New York Heart Association (NYHA) class III or IV heart failure; Acute or chronic hepatitis at screening (except chronic hepatitis B), autoimmune hepatitis, or significantly abnormal liver function: ALT or AST \\>3×ULN, or total bilirubin \\>2×ULN (except Gilbert syndrome); History of pancreatic injury; imaging findings suggestive of pancreatic space-occupying lesion, pancreatic atrophy, pancreatic calcification, or history of pancreatic surgery that may affect IPFD assessment; Contraindications to MRI examination (e.g., metallic implants in the body, claustrophobia, etc.) or inability to cooperate with breath-holding for the examination; Blood amylase or lipase \\>2×ULN at screening; Pregnant or lactating women, or positive pregnancy test at screening; women of childbearing potential who are unwilling to use medically accepted contraception during the study; Allergy to GLP-1 receptor agonists or any component of the study drug; or prior discontinuation of GLP-1 receptor agonist drugs due to safety or tolerability reasons; Participation in another interventional clinical trial within 3 months before screening; History of major depressive disorder, or current severe psychiatric illness (e.g., schizophrenia, bipolar disorder, etc.) judged by the investigator to be unable to comply with study procedures; History of conditions affecting gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, severe diabetic gastroparesis, etc.), long-term use of drugs directly affecting gastrointestinal motility, severe gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease, etc.), or prior gastrointestinal surgery (except surgeries with no significant effect on gastrointestinal motility, such as gastrointestinal polypectomy, appendectomy, and hemorrhoid surgery); Severe infection, severe trauma, or major or moderate surgery within 1 month before screening; Severe ECG abnormalities at screening (e.g., QTcF \\>450 ms, supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.), or poorly controlled blood pressure: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Additional laboratory criteria: alkaline phosphatase (ALP) ≥2×ULN; calcitonin ≥50 ng\u002FL; thyroid-stimulating hormone (TSH) \\\u003C0.4 or \\>6.0 mIU\u002FL; hemoglobin \\\u003C100 g\u002FL; Presence of acute or chronic hepatitis, or history of other severe liver diseases except metabolic-associated fatty liver disease; presence of significant hematologic diseases (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or diseases causing hemolysis\u002Fred blood cell instability; presence of autoimmune disease with planned systemic glucocorticoid or immunosuppressant therapy during the study; prior organ or bone marrow transplantation or planned transplantation during the trial; Known or suspected history of excessive alcohol consumption (weekly ethanol intake ≥210 g for men and ≥140 g for women for \\>3 months), or history of drug abuse or illicit drug use; Any other condition that, in the investigator's opinion, may affect compliance or safety assessment.","ALL","18 Years","60 Years",{"count":135,"type":136},194,"ESTIMATED","INTERVENTIONAL",[139],"NA","This is a randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial designed to evaluate the efficacy and safety of mazdutide in improving fatty pancreas in patients with overweight or obesity. The study plans to enroll 194 participants with overweight or obesity, who will be randomly assigned in a 1:1 ratio to either the mazdutide plus standardized lifestyle intervention group or the placebo plus standardized lifestyle intervention group, for a treatment duration of 48 weeks. The primary efficacy endpoint is the change from baseline in pancreatic proton density fat fraction (PDFF) measured by MRI at week 48. Secondary efficacy endpoints include changes in body weight, body mass index (BMI), waist circumference, glycemic and lipid metabolic parameters, visceral fat, and hepatic fat content. This study aims to provide preliminary evidence-based data supporting the application of mazdutide in the treatment of fatty pancreas associated with metabolic dysfunction.",[142,143,144],"Fatty Pancreas","Overweight","Obesity",[146,142,147],"overweight or obesity","Mazdutide","NOT_YET_RECRUITING","2026-09-17",{"date":151,"type":152},"2026-09-22","ACTUAL",{"date":154,"type":136},"2026-11-15",{"date":156,"type":136},"2028-12-30",{"name":5,"class":6},1]