[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654082":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":23,"studyPopulation":23,"armGroups":56,"interventions":70,"overallOfficials":23,"centralContacts":80,"locations":86,"responsibleParty":168,"collaborators":23,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":172,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":23,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":23,"overallStatus":89,"whyStopped":23,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Altimmune, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":23},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Clinical Outcome Event","Time to first occurrence of any of the following events through the end of the study: Histologic progression to cirrhosis (F4) on liver biopsy; Liver related events; Liver transplantation; or Death due to any cause","Baseline through end of study (approximately Month 60)",{"measure":14,"description":15,"timeFrame":16},"Histological Response: MASH resolution","Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network \\[CRN\\] classification) without worsening of fibrosis","Baseline through Week 52",{"measure":18,"description":19,"timeFrame":16},"Histological Response: Fibrosis improvement","Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH",[21,24,26,29,31,33,35,37,39,41,43],{"measure":22,"description":23,"timeFrame":16},"Histologic Response: Proportion of subjects achieving both MASH resolution (according to NASH CRN classification) without worsening of fibrosis and ≥ 1 stage improvement in liver fibrosis without worsening of MASH",null,{"measure":25,"description":23,"timeFrame":16},"HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis",{"measure":27,"description":23,"timeFrame":28},"Anthropometric parameters: Relative (%) change from baseline in body weight (kg)","Baseline through End of Study (approximately Month 60)",{"measure":30,"description":23,"timeFrame":28},"Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg\u002Fm2)",{"measure":32,"description":23,"timeFrame":28},"Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm)",{"measure":34,"description":23,"timeFrame":28},"Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in alanine aminotransferase (ALT; U\u002FL)",{"measure":36,"description":23,"timeFrame":28},"Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in enhanced liver fibrosis (ELF) score",{"measure":38,"description":23,"timeFrame":28},"Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Relative (%) change from baseline in vibration controlled transient elastography (VCTE; kPa) by Fibroscan",{"measure":40,"description":23,"timeFrame":28},"HRQoL: Change from baseline in core symptoms of MASH on the NASH-CHECK questionnaire.",{"measure":42,"description":23,"timeFrame":28},"HRQoL: Change from baseline in Short-form 36 (SF-36) summary scores.",{"measure":44,"description":23,"timeFrame":28},"HRQoL: Change from baseline in Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH) domain scores.",{"allocation":46,"interventionModel":47,"interventionModelDescription":23,"primaryPurpose":48,"observationalModel":23,"timePerspective":23,"maskingInfo":49},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":50,"maskingDescription":23,"whoMasked":51},"QUADRUPLE",[52,53,54,55],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[57,62,65],{"label":58,"type":59,"description":23,"interventionNames":60},"Pemvidutide 1.8 mg","EXPERIMENTAL",[61],"Drug: Pemvidutide",{"label":63,"type":59,"description":23,"interventionNames":64},"Pemvidutide 2.4 mg",[61],{"label":66,"type":67,"description":23,"interventionNames":68},"Placebo","PLACEBO_COMPARATOR",[69],"Other: Placebo",[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":23},"DRUG","Pemvidutide","Pemvidutide SC Injection",[58,63],{"type":77,"name":66,"description":78,"armGroupLabels":79,"otherNames":23},"OTHER","Placebo SC 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Beach","90815",{"type":96,"coordinates":130},[131,132],-118.18923,33.76696,{"lat":132,"lon":131},{"facility":88,"status":89,"city":135,"state":136,"zip":137,"country":93,"countryCode":94,"cosmosGeoPoint":138,"geoPoint":142,"contacts":23},"Miami","Florida","33173",{"type":96,"coordinates":139},[140,141],-80.19366,25.77427,{"lat":141,"lon":140},{"facility":88,"status":89,"city":144,"state":136,"zip":145,"country":93,"countryCode":94,"cosmosGeoPoint":146,"geoPoint":150,"contacts":23},"Ocala","34471",{"type":96,"coordinates":147},[148,149],-82.14009,29.1872,{"lat":149,"lon":148},{"facility":88,"status":89,"city":152,"state":153,"zip":154,"country":93,"countryCode":94,"cosmosGeoPoint":155,"geoPoint":159,"contacts":23},"Springboro","Ohio","45066",{"type":96,"coordinates":156},[157,158],-84.23327,39.55228,{"lat":158,"lon":157},{"facility":88,"status":89,"city":161,"state":153,"zip":162,"country":93,"countryCode":94,"cosmosGeoPoint":163,"geoPoint":167,"contacts":23},"Westlake","44145",{"type":96,"coordinates":164},[165,166],-81.91792,41.45532,{"lat":166,"lon":165},{"type":169,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","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":182,"type":183},1800,"ESTIMATED","INTERVENTIONAL",[186],"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.",[189],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)","2026-09-21",{"date":192,"type":193},"2026-09-23","ACTUAL",{"date":195,"type":193},"2026-07-30",{"date":197,"type":183},"2032-12",{"name":5,"class":6},9]