[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647990":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":43,"responsibleParty":103,"collaborators":106,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":27,"studyType":130,"phases":131,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":146,"whyStopped":27,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"GLP-1\u002FGCG receptor dual agonist plus lifestyle optimization (GG Group)","EXPERIMENTAL","Subcutaneous injection of mazdutide once weekly following a 12-week dose-escalation regimen: 2 mg q1w for Weeks 1-2, 4 mg q1w for Weeks 3-4 (if gastrointestinal tolerated), and a target dose of 6 mg q1w from Week 5 to Week 12 (if gastrointestinal tolerated). Standardized lifestyle optimization consists of an energy-restricted diet (deficit of 500-750 kcal\u002Fday, total daily intake \\\u003C=1500 kcal\u002Fday) and structured physical exercise (\\>=150 minutes\u002Fweek of moderate-to-high intensity exercise). A mandatory 1-week drug washout period is enforced prior to surgery.",[13,14],"Drug: Mazdutide","Behavioral: Lifestyle Optimization",{"label":16,"type":17,"description":18,"interventionNames":19},"Lifestyle optimization only (LL group)","PLACEBO_COMPARATOR","Subcutaneous injection of a matching placebo once weekly with identical appearance, volume, and injection device for 12 weeks. Standardized lifestyle optimization is identical to the experimental group, consisting of an energy-restricted diet (deficit of 500-750 kcal\u002Fday, total daily intake \\\u003C=1500 kcal\u002Fday) and structured physical exercise (\\>=150 minutes\u002Fweek of moderate-to-high intensity exercise). A matching 1-week placebo washout period is enforced prior to surgery to maintain blinding.",[20,14],"Drug: Placebo (Normal Saline)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Mazdutide","Active drug intervention consisting of a novel GLP-1\u002FGCG receptor dual agonist solution (Mazdutide) administered via subcutaneous injection once weekly using a single-use prefilled automatic injection pen. The dosing schedule follows a 12-week step-up titration regimen starting at 2 mg q1w for Weeks 1-2, increasing to 4 mg q1w for Weeks 3-4 if gastrointestinal tolerated, and reaching a target dose of 6 mg q1w from Week 5 to Week 12 if gastrointestinal tolerated. For participants with intolerable gastrointestinal adverse events, the titration cycle can be prolonged to 3 weeks, or they are permitted to maintain a lower tolerated dose based on multidisciplinary team consensus. To ensure surgical safety, this prehabilitation protocol enforces a mandatory 1-week drug washout period prior to hepatectomy, followed by a preoperative gastric ultrasound assessment by an anesthesiologist to rule out aspiration risks.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Placebo (Normal Saline)","Inactive comparator intervention consisting of a matching placebo (normal saline) solution administered via subcutaneous injection once weekly. To strictly maintain the double-blind design, the placebo features an identical appearance, volume, and automatic prefilled injection pen delivery device. The administration schedule, dose escalation simulation steps, and the mandatory 1-week pre-operative drug washout period mirror the experimental mazdutide group exactly to maintain the blinding integrity prior to the hepatectomy.",[16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"BEHAVIORAL","Lifestyle Optimization","Standardized lifestyle optimization provided to both groups, consisting of an calorie-restricted diet (CRD) and structured physical exercise. The CRD targets a daily calorie deficit of 500 to 750 kcal, with a total daily intake not exceeding 1500 kcal (1000-1200 kcal for females; 1200-1500 kcal for males). The structured exercise requires at least 5 days per week, totaling \\>=150 minutes of moderate-to-high intensity aerobic training with a daily energy expenditure \\>=150 kcal. Adherence is tracked objectively using a provided smart fitness tracker and daily electronic diaries without mandatory enforcement.",[9,16],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Kunlin Xie, MD, PhD","CONTACT","8618980607259","xiekun@scu.edu.cn",[44,67,85],{"facility":45,"status":27,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Anhui Provincial Hospital (The First Affiliated Hospital of USTC)","Hefei","Anhui","230036","China","CN",{"type":52,"coordinates":53},"Point",[54,55],117.28083,31.86389,{"lat":55,"lon":54},[58,62,64],{"name":59,"role":40,"phone":60,"phoneExt":27,"email":61},"Shugeng Zhang, MD","8615945965885","zsg0517@ustc.edu.cn",{"name":59,"role":63,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"name":65,"role":66,"phone":27,"phoneExt":27,"email":27},"Ning Wang, MD","SUB_INVESTIGATOR",{"facility":68,"status":27,"city":69,"state":70,"zip":71,"country":49,"countryCode":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Beijing Friendship Hospital, Capital Medical University","Beijing","Beijing Municipality","100050",{"type":52,"coordinates":73},[74,75],116.39723,39.9075,{"lat":75,"lon":74},[78,82,84],{"name":79,"role":40,"phone":80,"phoneExt":27,"email":81},"Lin Wei, MD","8618610932626","weilin@ccmu.edu.cn",{"name":83,"role":63,"phone":27,"phoneExt":27,"email":27},"Zhijun Zhu, MD",{"name":79,"role":63,"phone":27,"phoneExt":27,"email":27},{"facility":86,"status":27,"city":87,"state":88,"zip":89,"country":49,"countryCode":50,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"West China Hospital, Sichuan University","Chengdu","Sichuan","610041",{"type":52,"coordinates":91},[92,93],104.06667,30.66667,{"lat":93,"lon":92},[96,97,99,101],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},{"name":98,"role":63,"phone":27,"phoneExt":27,"email":27},"Hong Wu, MD",{"name":100,"role":63,"phone":27,"phoneExt":27,"email":27},"Kunlin Xie, MD",{"name":102,"role":66,"phone":27,"phoneExt":27,"email":27},"Hongzhao Yang, MBBS",{"type":63,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Kunlin Xie","Associate professor",[107,109,112,114],{"name":108,"class":6},"Beijing Friendship Hospital",{"name":110,"class":111},"Anhui Provincial Hospital","OTHER_GOV",{"name":113,"class":6},"The Second Affiliated Hospital of Chongqing Medical University",{"name":115,"class":6},"First Affiliated Hospital of Chongqing Medical University","100647990","phase-2-pre-hepatectomy-rehabilitation-in-obese-masld-complicated-living-liver-donors-with-mazdutide-prime-100647990",false,"NCT07718126","Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)","Short-term Mazdutide Plus Lifestyle Intervention Versus Placebo for Pre-hepatectomy Prehabilitation in Living Liver Donors With MASLD: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial","PRIME","Inclusion Criteria:\n\n* Age between 18 and 60 years old at the time of signing the informed consent form.\n* Overweight, defined as Body Mass Index (BMI) ≥ 24 kg\u002Fm².\n* Diagnosed with MASLD by non-invasive means (conventional ultrasound, FibroScan®, or MRI), with a Controlled Attenuation Parameter (CAP) ≥ 268 dB\u002Fm via FibroScan®.\n* Histologically confirmed MASLD without any liver fibrosis, presenting a NAS ≥ 3, including a steatosis subscore ≥ 2 (subscores for hepatocyte ballooning and lobular inflammation are not limited).\n* Meets ethical and legal regulations, voluntarily donates a portion of the liver, and the corresponding potential liver transplant recipient must be a spouse or a direct or collateral blood relative within three generations.\n* Understands all procedures and follow-up requirements of the study, participates voluntarily, and signs the written informed consent form in person.\n\nExclusion Criteria:\n\n* Liver biopsy indicates complication with any degree of liver fibrosis.\n* Failure to diagnose overweight or MASLD by non-invasive means, including BMI \\\u003C 24 kg\u002Fm² and\u002For CAP \\\u003C 268 dB\u002Fm.\n* Histological evaluation shows a total NAS \\\u003C 3 and\u002For a steatosis subscore \\\u003C 2.\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN) at screening, and\u002For ALT or AST levels increase by more than 1 fold compared to baseline during screening, which is considered clinically significant by the investigator.\n* Total bilirubin (TBil) \\> 25.6 μmol\u002FL (1.5 mg\u002FdL), and\u002For alkaline phosphatase (ALP) \\> 2 × ULN, and\u002For International Normalized Ratio (INR) \\> 1.35 at screening.\n* Platelet count \\\u003C 150,000\u002FμL at screening, unless considered by the investigator to reflect the patient's daily baseline level and portal hypertension is absent.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m² based on the CKD-EPI formula at screening.\n* Glycated hemoglobin (HbA1c) \\> 9.5% at screening.\n* Unstable weight, defined as self-reported weight change \\> 5% within 90 days prior to screening up to the time of screening.\n* Presence of other clearly defined etiologies causing chronic liver disease (non-NAFLD), including positive HBsAg, positive anti-HIV, or positive HCV RNA at screening, or a known history of HCV RNA or HBsAg positivity within 2 years prior to screening.\n* Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatocellular carcinoma, or liver transplantation at screening and randomization.\n* Presence or history of malignant tumors within 5 years (except basal cell carcinoma, squamous cell skin cancer, and any carcinoma in situ).\n* Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).\n* History of acute pancreatitis within 180 days prior to screening, or a history of chronic pancreatitis.\n* Presence or history of gastroparesis, severe gastroesophageal reflux disease, or prior bariatric surgery at screening and randomization.\n* History or presence of type 1 diabetes.\n* Occurrence of myocardial infarction, stroke, NYHA class IV heart failure, hospitalization due to unstable angina, or transient ischemic attack within 90 days prior to screening or during the screening-to-randomization window.\n* Type 2 diabetes accompanied by uncontrolled and potentially unstable diabetic retinopathy or maculopathy.\n* History of severe depression, suicidal ideation, or recent suicide attempts.\n* Known or suspected allergy to the active ingredients or any excipients of the study drug.\n* Females who are pregnant, lactating, planning a pregnancy, or of childbearing potential but not utilizing highly effective contraceptive methods.\n* Participation in any approved or unapproved investigational drug clinical trial within 180 days prior to screening (defined as exposure to the investigational drug and inclusive of any post-treatment follow-up period).\n* Prior participation in this trial (defined as having already undergone randomization).\n* Known or suspected excessive alcohol consumption (females \\> 20g\u002Fday, males \\> 30g\u002Fday) or presence of alcohol dependence.\n* Use of any GLP-1 receptor agonist (GLP-1RA) within 90 days prior to screening.\n* Receipt of glucose-lowering drugs (except GLP-1RA), lipid-lowering drugs, or weight-loss drugs considered by the investigator to be at unstable doses within 90 days prior to screening.\n* Any condition considered by the investigator to render the participant unsuitable for liver donation, or diseases\u002Fconditions that may compromise participant safety, pose safety hazards from substantial weight loss, or affect compliance with the protocol.\n* The recipient designated to receive the liver graft is not a spouse or a direct or collateral blood relative within three generations, or the donation violates ethical, moral, legal, or regulatory codes.","ALL","18 Years","60 Years",{"count":128,"type":129},60,"ESTIMATED","INTERVENTIONAL",[132,133],"PHASE2","PHASE3","The purpose of this study is to evaluate the efficacy and safety of a short-term (12-week) prehabilitation strategy combining mazdutide (a novel GLP-1\u002FGCG receptor dual agonist) with lifestyle optimization, compared to lifestyle optimization alone, in potential living liver transplantation donors with metabolic dysfunction-associated steatohepatitis (MASLD).\n\nOverweight or obese individuals who intend to donate a portion of their liver but are temporarily disqualified due to hepatic steatosis will be recruited across multiple clinical centers. Participants will be randomly assigned in a 1:1 ratio to either the experimental group (mazdutide subcutaneous injection once weekly plus standardized lifestyle counseling) or the control group (placebo subcutaneous injection once weekly plus standardized lifestyle counseling).\n\nThe primary objective is to determine whether the short-term addition of mazdutide can significantly increase the proportion of donors achieving histological resolution of hepatic steatosis without the worsening of fibrosis within 12 weeks. The study ultimately aims to provide high-quality evidence for a rapid, safe, and effective surgical prehabilitation protocol to expand the living donor pool and optimize perioperative outcomes for both donors and recipients.",[136,137,138],"Metabolic Dysfunction-Associated Steatohepatitis","Hepatic Steatosis","Living Liver Donors",[24,140,141,142,143,144,145],"GLP-1\u002FGCG receptor dual agonist","Living Donor Liver Transplantation","Prehabilitation","MASLD","Organ Donation","Preoperative Weight Loss","NOT_YET_RECRUITING","2026-07-16",{"date":149,"type":150},"2026-07-21","ACTUAL",{"date":152,"type":129},"2026-09-01",{"date":154,"type":129},"2028-08-31",{"name":5,"class":6},3]