[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647219":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":85,"collaborators":30,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":30,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":51,"whyStopped":30,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Participants receiving Efimosfermin alfa","EXPERIMENTAL","Participants will receive efimosfermin alfa in Part A of the study.",[13],"Drug: Efimosfermin alfa",{"label":15,"type":16,"description":17,"interventionNames":18},"Part A: Participants receiving Placebo","PLACEBO_COMPARATOR","Participants will receive placebo in Part A of the study.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Part B: Participants receiving Efimosfermin alfa","All participants will receive efimosfermin alfa in Part B of the study.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Efimosfermin alfa","Efimosfermin alfa (subcutaneous injection) will be administered.",[9,21],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Placebo","Placebo (subcutaneous injection) will be administered.",[15],[36],{"name":37,"affiliation":5,"role":38},"GSK Clinical Trials","STUDY_DIRECTOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":46,"role":42,"phone":47,"phoneExt":30,"email":44},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[49,71],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"GSK Investigational Site","RECRUITING","Miami","Florida","33135","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-80.19366,25.77427,{"lat":61,"lon":60},[64,65,68],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},{"name":66,"role":42,"phone":67,"phoneExt":30,"email":44},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":69,"role":70,"phone":30,"phoneExt":30,"email":30},"Yaneicy Gonzalez Rojas","PRINCIPAL_INVESTIGATOR",{"facility":50,"status":51,"city":72,"state":73,"zip":74,"country":55,"countryCode":56,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Houston","Texas","77058",{"type":58,"coordinates":76},[77,78],-95.36327,29.76328,{"lat":78,"lon":77},[81,82,83],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},{"name":66,"role":42,"phone":67,"phoneExt":30,"email":44},{"name":84,"role":70,"phone":30,"phoneExt":30,"email":30},"Joe Pouzar",{"type":86,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100647219","phase-3-a-study-to-investigate-safety-and-efficacy-of-efimosfermin-compared-with-placebo-in-adult-participants-with-compensated-cirrhosis-due-to-metabolic-dysfunction-associated-steatohepatitis-mash-100647219",false,"NCT07704892","A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 3, Two-part, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis (Stage F4 Fibrosis) Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-2)","NEBULA-2","Inclusion Criteria:\n\n* Participants aged between 18 and 75 years at enrolment.\n* Participants with history or presence of at least two components of metabolic syndrome.\n* Liver biopsy consistent with cirrhosis (fibrosis stage 4).\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 mellitus complications.\n* History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.\n* A recent history or planned surgical procedures or medications intended to produce significant weight loss.\n* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \\>= 5 times upper limit normal (ULN).\n* Current or history of excessive alcohol intake","ALL","18 Years","75 Years",{"count":99,"type":100},380,"ESTIMATED","INTERVENTIONAL",[103],"PHASE3","This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.",[106],"Metabolic Dysfunction-associated Steatohepatitis",[108,109,110,111,112],"Cirrhosis","Efimosfermin","Fibrosis","Metabolic dysfunction-associated","Steatohepatitis","2026-08-03",{"date":115,"type":116},"2026-08-05","ACTUAL",{"date":118,"type":116},"2026-07-22",{"date":120,"type":100},"2033-12-08",{"name":5,"class":6},2]