[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nash-non-alcoholic-steatohepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nash-non-alcoholic-steatohepatitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"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":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"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) .",[26,27],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","NASH (Non-Alcoholic Steatohepatitis)","NOT_YET_RECRUITING","2026-06-15",{"date":31,"type":32},"2026-06-17","ACTUAL",{"date":34,"type":20},"2026-06-30",{"date":36,"type":20},"2032-12-30",{"name":38,"class":39},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100566936","evaluation-of-a-new-ultrasound-system-for-the-non-invasive-assessment-of-liver-steatosis-in-masldmash-patients-100566936","NCT06661655","Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD\u002FMASH Patients","ACOUSTIQ","Inclusion Criteria:\n\n* Adult patient below 80 yo\n* Patients with MASLD\u002FMASH recruited in interventional trials requiring MRI PDFF +\u002F- MRE per interventional protocol, OR\n* Patients with MASLD\u002FMASH recruited in prospective cohorts requiring MRI PDFF +\u002F- MRE per interventional protocol, OR\n* Patients referred to MRI-PDFF or MRE.\n* Patients who consented in written to participate in the study\n* Patients with ongoing social security coverage\n\nExclusion Criteria:\n\n* Patient in their minority (less than 18 yo) or older than 80 yo,\n* Patient with active implants,\n* Patient presenting with a wound where the Hepatoscope exam shall be performed (abdominal right upper quadrant)\n* Patient with a history of decompensated cirrhosis,\n* Patient with a history of hepatocellular carcinoma,\n* Adult patient under tutorship, or unable to express informed consent,\n* Pregnant or breast-feeding\n* Person deprived from their liberty\n* Patient hospitalized without providing consent or in case of an emergency\n* Patient presenting with another know liver disease","80 Years",{"count":49,"type":20},120,[51],"NA","The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.",[54,55,26,56,27,57,58],"Metabolic Syndrome X","Fatty Liver","MASLD","Steatosis, Liver","NAFLD",[60,61,62,63,64,65,66,67,68,69],"Liver","Fibrosis","Steatosis","Elastography","Ultrasound","Attenuation","Backscattering coefficient","Sound speed","MRI PDFF","Hepatoscope","RECRUITING","2025-08-12",{"date":73,"type":32},"2025-08-15",{"date":75,"type":32},"2025-07-24",{"date":77,"type":20},"2026-09-01",{"name":79,"class":39},"E-Scopics",3]