[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641831":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":17,"centralContacts":29,"locations":17,"responsibleParty":35,"collaborators":17,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":17,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":17,"enrollmentInfo":46,"targetDuration":17,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":17,"overallStatus":56,"whyStopped":17,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":17},{"fullName":5,"class":6},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HSK31679 dose","EXPERIMENTAL","HSK31679 tablet, orally, once daily",[13],"Drug: HSK31679",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR",null,[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":17},"DRUG","HSK31679","tablet",[9],{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":17},"Matching tablet",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":17,"email":34},"fangqiong li","CONTACT","028-67258840","lifangq@haisco.com",{"type":36,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100641831","phase-3-a-phase-3-study-evaluating-the-safety-and-efficacy-of-hsk31679-in-patients-with-mash-100641831",false,"NCT07581951","A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)","Key Inclusion Criteria:\n\n* 1\\. Must be willing to participate in the study and provide written informed consent.\n* 2.Male and female adults ≥ 18 years of age.\n* 3.Have at least one cardiometabolic risk factors at screening.\n* 4.MRI-PDFF fat fraction ≥8%.\n* 5.Have a liver biopsy performed within 6 months prior to randomization, with histologically confirmed MASH assessed by the central laboratory; NAS score ≥ 4 points with at least 1 point each for inflammation and hepatocellular ballooning; meanwhile, CRN fibrosis stage is F2 ≤ fibrosis \\\u003C F4. If no liver biopsy data are available within 6 months prior to randomization, a liver biopsy must be completed during the screening period.\n* 6.Body weight fluctuation \\\u003C 5% for at least 6 weeks before randomization.\n\nKey Exclusion Criteria:\n\n* 1\\. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.\n* 2.MELD score ≥12 due to hepatic disease。\n* 3.Received medication therapy that may induce MAFLD\u002FMASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy).\n* 4.Participants who had not been on stable medication with vitamin E (dose\\>400 IU\u002Fday) or polyunsaturated fatty acids or ursodeoxycholic acid within 6 months prior to liver biopsy (including historical biopsy); or had not been on stable medication with thiazolidinediones (TZD), sodium-glucose cotransporter 2 (SGLT2) inhibitors, or complex oral antidiabetic (OAD) regimens (≥3 OADs) within 3 months prior to liver biopsy (including historical biopsy).\n* 5.Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study.\n* 6.HbA1c ≥ 8.0%.\n* 7.Chronic liver diseases other than NASH.\n* 8.Active autoimmune disease. 9.Serum ALT \\> 250 U\u002FL. 10.Active, serious medical disease with a likely life expectancy \\\u003C 2 years.","ALL","18 Years",{"count":47,"type":48},400,"ESTIMATED","INTERVENTIONAL",[51],"PHASE3","A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .",[54,55],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","NASH (Non-Alcoholic Steatohepatitis)","NOT_YET_RECRUITING","2026-06-15",{"date":59,"type":60},"2026-06-17","ACTUAL",{"date":62,"type":48},"2026-06-30",{"date":64,"type":48},"2032-12-30",{"name":5,"class":6}]