[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645475":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":65,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants receiving efimosfermin alfa","EXPERIMENTAL",null,[13],"Drug: Efimosfermin alfa",{"label":15,"type":16,"description":11,"interventionNames":17},"Participants receiving placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Efimosfermin alfa","Efimosfermin alfa (subcutaneous injection) will be administered.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","Placebo (subcutaneous injection) will be administered.",[15],[30],{"name":31,"affiliation":5,"role":32},"GSK Clinical Trials","STUDY_DIRECTOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":40,"role":36,"phone":41,"phoneExt":11,"email":38},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"GSK Investigational Site","RECRUITING","Miami","Florida","33135","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-80.19366,25.77427,{"lat":55,"lon":54},[58,59,62],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},{"name":60,"role":36,"phone":61,"phoneExt":11,"email":38},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":63,"role":64,"phone":11,"phoneExt":11,"email":11},"Yaneicy Gonzalez Rojas","PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100645475","phase-3-a-pivotal-clinical-study-to-investigate-the-safety-and-efficacy-of-efimosfermin-compared-with-placebo-in-adult-participants-with-compensated-cirrhosis-due-to-metabolic-dysfunction-associated-steatohepatitis-mash-100645475",false,"NCT07701993","A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)","NEBULA-1","Inclusion Criteria:\n\n* Participants aged between 18 and 75 years at enrollment.\n* Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.\n* Participants with history or presence of at least two components of metabolic syndrome.\n\nExclusion Criteria:\n\n* Participants with other chronic liver diseases.\n* Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.\n* Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications.\n* Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.\n* Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.\n* Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>=5 times upper limit normal (ULN).\n* Participants with current or history of excessive alcohol intake.","ALL","18 Years","75 Years",{"count":79,"type":80},1740,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.",[86],"Metabolic Dysfunction-associated Steatohepatitis",[22,88,89,90,91],"Metabolic dysfunction-associated","steatohepatitis","Fibrosis","Cirrhosis","2026-08-03",{"date":94,"type":95},"2026-08-05","ACTUAL",{"date":97,"type":95},"2026-07-22",{"date":99,"type":80},"2033-08-24",{"name":5,"class":6},1]