[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616299":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":48,"centralContacts":53,"locations":63,"responsibleParty":217,"collaborators":221,"id":225,"slug":226,"hasResults":227,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":227,"sex":233,"minAge":234,"maxAge":235,"enrollmentInfo":236,"targetDuration":57,"studyType":239,"phases":240,"briefSummary":242,"conditions":243,"keywords":246,"overallStatus":172,"whyStopped":57,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Chiglitazar Placebo + vitamin E + polyene phosphatidyl choline","PLACEBO_COMPARATOR","Chiglitazar placebo given orally once a day",[13,14,15],"Drug: Chiglitazar Placebo","Drug: vitamin E","Drug: Polyene Phosphatidyl choline",{"label":17,"type":18,"description":19,"interventionNames":20},"48mg Chiglitazar + vitamin E + polyene phosphatidyl choline","EXPERIMENTAL","48mg Chiglitazar given orally once a day",[21,14,15],"Drug: Chiglitazar",[23,30,36,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Chiglitazar Placebo","Chiglitazar Placebo 48mg\u002Fday",[9],[29],"simulant of chiglitazar",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Chiglitazar","Chiglitazar 48mg\u002Fday",[17],[35],"Carfloglitazar",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"vitamin E","Vitamin E 100mg\u002Fthree times a day",[17,9],[41],"Laiyi",{"type":24,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Polyene Phosphatidyl choline","Polyene Phosphatidyl choline 456mg\u002Fthree times a day",[17,9],[47],"Yi Shan 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Municipality","300192",{"type":73,"coordinates":193},[194,195],117.17667,39.14222,{"lat":195,"lon":194},{"facility":198,"status":66,"city":199,"state":200,"zip":201,"country":70,"countryCode":71,"cosmosGeoPoint":202,"geoPoint":206,"contacts":57},"The First Teaching Hospital of Xinjiang Medical University","Ürümqi","Xinjiang","830054",{"type":73,"coordinates":203},[204,205],87.60046,43.80096,{"lat":205,"lon":204},{"facility":208,"status":66,"city":209,"state":210,"zip":211,"country":70,"countryCode":71,"cosmosGeoPoint":212,"geoPoint":216,"contacts":57},"The First Affiliated Hospital of Zhejiang University","Hangzhou","Zhejiang","310003",{"type":73,"coordinates":213},[214,215],120.16142,30.29365,{"lat":215,"lon":214},{"type":52,"investigatorFullName":218,"investigatorTitle":219,"investigatorAffiliation":220,"oldNameTitle":57,"oldOrganization":57},"Hai Li","Professor, Department of Gastroenterology, Punan Campus, RenJi Hospital","Shanghai Punan Hospital of Pudong New District",[222],{"name":223,"class":224},"Chipscreen Biosciences, Ltd.","INDUSTRY","100616299","phase-2-a-study-of-chiglitazar-in-patients-with-metabolic-dysfunction-associated-steatohepatitis-and-type-2-diabetes-mellitus-100616299",false,"NCT07303803","A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus","Chiglitazar in Combination With Anti-Inflammatory and Hepatoprotective Therapy for the Treatment in MASH Associated With T2DM: a Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Study","CHIG-MASH","Inclusion Criteria:\n\n1. Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.\n2. Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.\n3. Participants must take Fibroscan examination with the result of CAP ≥ 238 dB\u002Fm and LSM\\>8.5 kPa.\n4. Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 1b or more over according to the NASH Clinical Research Network (CRN) scoring system. (or liver biopsy not more than 6 months prior to screening)\n5. Stable body weight (≤10% body weight change) for at least 3 months.\n6. Possess good understanding and behavior and be able to take the medication daily as required by the trial.\n7. Willing to sign the informed consent.\n\nExclusion Criteria:\n\n1. Alcohol consumption \\>20g ethyl alcohol\u002Fday for women and \\>40g ethyl alcohol\u002Fday for men.\n2. Evidence of other forms of chronic liver disease:\n\n   1. Alcoholic liver disease,\n   2. Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,\n   3. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),\n   4. Evidence of autoimmune liver disease as defined by compatible liver histology,\n   5. Current drug-induced liver disease as defined on the basis of typical exposure and history,\n   6. Suspected or proven liver cancer,\n   7. Any other type of liver disease other than MASH.\n3. Uncontrolled T2DM defined as HbA1c \\>9.5% at time of screening or Type 1 diabetes mellitus (T1DM).\n4. Patients with T2DM who have a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy or severe non-proliferative diabetic retinopathy that requires acute treatment.\n5. Any of the following cardiovascular conditions within 6 months prior to screening:\n\n   1. acute myocardial infarction (MI),\n   2. cerebrovascular accident (stroke),\n   3. unstable angina,\n   4. hospitalization due to congestive heart failure (CHF)\n   5. New York Heart Association Functional Classification IV CHF\n6. History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.\n7. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥ 100 mm Hg).\n8. Renal impairment measured as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n9. Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility.\n10. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).\n11. Evidence of untreated hypothyroidism or hyperthyroidism based on clinical or laboratory evaluation.\n12. A transplanted organ (corneal transplants allowed) or awaiting an organ transplant.\n13. Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial (at least include one barrier contraceptive method) and breast feeding.\n14. Use of drugs associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening.\n15. Current use of medication is associated with weight gain, except when on stable dose for at least 3 months prior to screening and remaining on stable dose during the study.\n16. Receiving or having received (within 3 months of screening) chronic (\\>2 weeks) systemic glucocorticoid therapy.\n17. Use of treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists or PPAR pan agonists).\n18. Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.","ALL","18 Years","75 Years",{"count":237,"type":238},300,"ESTIMATED","INTERVENTIONAL",[241],"PHASE2","This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.",[244,245],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","T2DM (Type 2 Diabetes Mellitus)",[247,248,249,250],"chiglitazar","metabolic dysfunction-associated steatohepatitis","type 2 diabetes","liver biopsy","2026-06-01",{"date":253,"type":254},"2026-06-03","ACTUAL",{"date":256,"type":254},"2026-01-01",{"date":258,"type":238},"2030-12-01",{"name":5,"class":6},17]