[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Akero Therapeutics, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100532662","phase-3-a-study-evaluating-efruxifermin-in-subjects-with-non-cirrhotic-nonalcoholic-steatohepatitis-nashmetabolic-dysfunction-associated-steatohepatitis-mash-and-fibrosis-100532662",false,"NCT06215716","A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)\u002FMetabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)\u002FMetabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","Inclusion Criteria:\n\n* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.\n* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.\n* Cohort 1: Biopsy-proven NASH\u002FMASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:\n\n  * Steatosis (scored 0 to 3),\n  * Ballooning degeneration (scored 0 to 2), and\n  * Lobular inflammation (scored 0 to 3).\n* Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \\\u003C4 may be enrolled and are not required to meet 1 point in each of the components of NAS.\n\nExclusion Criteria:\n\n* Other causes of liver disease based on medical history and\u002For liver histology and\u002For central laboratory results.\n* Presence of cirrhosis on liver biopsy (fibrosis stage 4).\n* Type 1 or uncontrolled Type 2 diabetes.\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":20,"type":21},1650,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH\u002FMASH and fibrosis stage 2 or 3 (F2 or F3).\n\nThe study will enroll subjects in two cohorts for a total samples size of 1650 subjects.",[27,28],"NASH With Fibrosis","MASH With Fibrosis","RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":33},"2023-12-01",{"date":37,"type":21},"2033-02",{"name":39,"class":40},"Akero Therapeutics, Inc","INDUSTRY",356,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100556685","phase-3-a-study-evaluating-efruxifermin-in-subjects-with-compensated-cirrhosis-due-to-nashmash-100556685","NCT06528314","A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH\u002FMASH","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH\u002FMASH","Inclusion Criteria:\n\n* Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH\u002FMASH and NAS score of \\>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities\n* Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH\u002FMASH\n\nExclusion Criteria:\n\n* Other causes of liver disease based on medical history and\u002For liver histology and\u002For central laboratory results\n* Type 1 diabetes or unstable Type 2 diabetes\n* Any current or prior history of decompensated liver disease\n\nOther inclusion and exclusion criteria may apply.",{"count":50,"type":21},2150,[24],"This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH\u002FMASH.",[54,55],"NASH - Nonalcoholic Steatohepatitis","MASH - Metabolic Dysfunction-Associated Steatohepatitis","2026-06-04",{"date":58,"type":33},"2026-06-08",{"date":60,"type":33},"2024-09-04",{"date":62,"type":21},"2030-03",{"name":39,"class":40},322,""]