[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Altimmune, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100654082","phase-3-phase-3-study-of-the-efficacy-safety-and-clinical-outcomes-of-pemvidutide-in-mash-100654082",false,"NCT07795164","Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH","A Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects With Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)","PERFORMA","Inclusion Criteria:\n\nAll subjects:\n\n* No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable)\n* Body mass index (BMI) ≥ 25.0 kg\u002Fm2; if Asian, BMI ≥ 23.0 kg\u002Fm2\n* Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome\n* Subject agrees to have liver biopsy(ies) as required per protocol\n\nCohort 1 - Histologic diagnosis of F2\u002FF3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening\n\nCohort 2 - Presumed F2\u002FF3 MASH based on noninvasive testing\n\nExclusion Criteria:\n\n* Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C\n* Uncontrolled T2D or clinically significant persistent hyperglycemia","ALL","18 Years","75 Years",{"count":21,"type":22},1800,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Phase 3, multicenter, multinational, 2-cohort, randomized, double-blind, placebo controlled, parallel-group pivotal study to evaluate the efficacy, safety, and clinical outcomes of pemvidutide treatment in subjects with noncirrhotic (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH). Participants will be assigned either to Cohort 1 based on screening histologic (liver biopsy) criteria or to Cohort 2 based on non-invasive test criteria.",[28],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)","RECRUITING","2026-09-21",{"date":32,"type":33},"2026-09-23","ACTUAL",{"date":35,"type":33},"2026-07-30",{"date":37,"type":22},"2032-12",{"name":39,"class":40},"Altimmune, Inc.","INDUSTRY",9,""]