[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-dysfunction-associated-steatohepatitis-mash--nonalcoholic-steatohepatitis-nash-with-compensated-cirrhosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-dysfunction-associated-steatohepatitis-mash--nonalcoholic-steatohepatitis-nash-with-compensated-cirrhosis":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,68],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100053409",false,"NCT06419374","A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).\n* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.\n* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.\n* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \\\u003C50.0 kilograms (kg)\u002Fmeters squared (m\\^2).\n\nKey Exclusion Criteria:\n\n* Liver disorder other than MASH.\n* History or evidence of hepatic decompensation.\n* History or evidence of hepatocellular carcinoma.\n* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.\n* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL).\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) must be on stable dose for at least 6 months prior to screening.\n\nOther protocol-defined inclusion and exclusion criteria may apply.","ALL","18 Years","75 Years",{"count":19,"type":20},762,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \\[previously known as nonalcoholic steatohepatitis, NASH\\]).",[26],"Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis",[28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Liver disease","Fatty Liver","Digestive System Diseases","Metabolic diseases","Metabolic Dysfunction-Associated Steatohepatitis","MASH","Nonalcoholic steatohepatitis","NASH","Metabolic dysfunction-associated steatotic liver disease","MASLD","Nonalcoholic fatty liver disease","NAFLD","Fibrosis","Cirrhosis","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":46},"2024-05-24",{"date":50,"type":20},"2031-08",{"name":52,"class":53},"89bio, Inc.","INDUSTRY",317,{"id":56,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":24,"conditions":59,"keywords":60,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":67},"100548313",{"count":19,"type":20},[23],[26],[28,29,30,31,32,33,34,35,36,37,38,39,40,41],"2026-06-02",{"date":63,"type":46},"2026-06-04",{"date":48,"type":46},{"date":50,"type":20},{"name":52,"class":53},303,{"id":69,"slug":4,"hasResults":10,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":72,"conditions":78,"keywords":82,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100635513","NCT07553663","Evaluating the Pharmacokinetics and Safety of Miricorilant","A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB\u002Fm OR historical biopsy within 12 months of screening that meets the following criteria:\n\n  1. Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 3 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis score of F1 OR\n  2. NAS ≥ 2 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F2 or 3.\n* Aspartate aminotransferase (AST) \\> 17 U\u002FL for women and AST \\> 20 U\u002FL for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of Screening.\n* Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:\n\n  1. Diagnosis of type 2 diabetes OR\n  2. Presence of 2 or more components of metabolic syndrome:\n\n     * Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or treatment for elevated blood glucose\n     * Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension\n     * Serum triglycerides ≥ 150 mg\u002FdL (1.7 mmol\u002FL) or drug treatment for elevated triglycerides\n     * Serum high-density lipoprotein (HDL) cholesterol \\\u003C 40 mg\u002FdL (1 mmol\u002FL) in men and \\\u003C 50 mg\u002FdL (1.3 mmol\u002FL) in women or drug treatment for low HDL\n     * Overweight or obese (body mass index \\[BMI\\] ≥ 25 kg\u002Fm2 \\[BMI ≥ 23 kg\u002Fm2 in Asians\\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm \\[35.4 in\\]; women ≥ 80 cm \\[31.5 in\\] in Asians).\n\nExclusion Criteria:\n\n* Women who are pregnant, planning to become pregnant, or are lactating.\n* Have a BMI \\\u003C 18 kg\u002Fm2 or \\> 45 kg\u002Fm2.\n* Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire\n* Have had liver transplantation or plan to have liver transplantation during the study.\n* Have type 1 diabetes.\n* Have poorly controlled type 2 diabetes with a glycated hemoglobin (HbA1c)\n\n  * 9.5%.\n* Have any other chronic liver disease\n* History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation\n* Have hepatic decompensation\n\nOther exclusion criteria may apply",{"count":75,"type":20},15,[77],"PHASE1",[79,26,80,81],"Nonalcoholic Steatohepatitis (NASH)","Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Non-alcoholic Fatty Liver Disease (NAFLD)",[83,79,84,85],"Nonalcoholic Fatty Liver Disease (NAFLD)","Metabolic dysfunction-Associated Steatohepatitis (MASH)","Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)","2026-05-21",{"date":88,"type":46},"2026-05-26",{"date":90,"type":46},"2026-04-30",{"date":92,"type":20},"2026-10-30",{"name":94,"class":53},"Corcept Therapeutics",1,""]