[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653768":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":22,"studyPopulation":22,"armGroups":56,"interventions":77,"overallOfficials":86,"centralContacts":90,"locations":99,"responsibleParty":159,"collaborators":22,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":163,"sex":169,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":22,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":102,"whyStopped":22,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)","VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascals (kPa)","Baseline (Day 1) and up to Week 60",{"measure":14,"description":15,"timeFrame":12},"Change from Baseline in model for end-stage liver disease (MELD) score","MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.",[17,20,24,27,30,32,34,37,39,41,43],{"measure":18,"description":19,"timeFrame":12},"Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter)","This is a measurement of the AST enzyme in the blood.",{"measure":21,"description":22,"timeFrame":23},"Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease",null,"Baseline (Day 1) and up to Week 52",{"measure":25,"description":22,"timeFrame":26},"Trough Concentration at steady state (Ctrough,ss) following administration of efimosfermin alfa","Up to Week 56",{"measure":28,"description":22,"timeFrame":29},"Area Under the concentration-time Curve from Time 0 (pre-dose) to the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa in the subset of participants with optional intensive pharmacokinetics (PK) sampling","Up to Week 4",{"measure":31,"description":22,"timeFrame":29},"Maximum observed drug concentration (Cmax) of efimosfermin alfa in the subset of participants with optional intensive PK sampling",{"measure":33,"description":22,"timeFrame":26},"Number of Participants with Anti-drug antibodies (ADA) against efimosfermin alfa",{"measure":35,"description":22,"timeFrame":36},"Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity","Up to Week 60",{"measure":38,"description":22,"timeFrame":36},"Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity",{"measure":40,"description":22,"timeFrame":36},"Number of participants with Grade 3 and Grade 4 laboratory abnormalities",{"measure":42,"description":22,"timeFrame":36},"Number of participants with clinically significant changes in Vital signs",{"measure":44,"description":22,"timeFrame":36},"Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) findings",{"allocation":46,"interventionModel":47,"interventionModelDescription":22,"primaryPurpose":48,"observationalModel":22,"timePerspective":22,"maskingInfo":49},"NA","SEQUENTIAL","TREATMENT",{"masking":50,"maskingDescription":22,"whoMasked":51},"QUADRUPLE",[52,53,54,55],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[57,63,67,71],{"label":58,"type":59,"description":60,"interventionNames":61},"Efimosfermin alfa Dose Level 1","EXPERIMENTAL","Participants will receive efimosfermin alfa dose level 1.",[62],"Drug: Efimosfermin alfa",{"label":64,"type":59,"description":65,"interventionNames":66},"Efimosfermin alfa Dose Level 2","Participants will receive efimosfermin alfa dose level 2.",[62],{"label":68,"type":59,"description":69,"interventionNames":70},"Efimosfermin alfa Dose Level 3","Participants will receive efimosfermin alfa dose level 3.",[62],{"label":72,"type":73,"description":74,"interventionNames":75},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo.",[76],"Drug: Placebo",[78,83],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":22},"DRUG","Efimosfermin alfa","Efimosfermin alfa will be administered.",[58,64,68],{"type":79,"name":72,"description":84,"armGroupLabels":85,"otherNames":22},"Placebo will be administered.",[72],[87],{"name":88,"affiliation":5,"role":89},"GSK Clinical Trials","STUDY_DIRECTOR",[91,96],{"name":92,"role":93,"phone":94,"phoneExt":22,"email":95},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":97,"role":93,"phone":98,"phoneExt":22,"email":95},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[100,122,136,149],{"facility":101,"status":102,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"GSK Investigational Site","RECRUITING","Topeka","Kansas","66606","United States","US",{"type":109,"coordinates":110},"Point",[111,112],-95.67804,39.04833,{"lat":112,"lon":111},[115,116,119],{"name":92,"role":93,"phone":94,"phoneExt":22,"email":95},{"name":117,"role":93,"phone":118,"phoneExt":22,"email":95},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":120,"role":121,"phone":22,"phoneExt":22,"email":22},"Shekhar Challa","PRINCIPAL_INVESTIGATOR",{"facility":101,"status":102,"city":123,"state":124,"zip":125,"country":106,"countryCode":107,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Fort Worth","Texas","76104",{"type":109,"coordinates":127},[128,129],-97.32085,32.72541,{"lat":129,"lon":128},[132,133,134],{"name":92,"role":93,"phone":94,"phoneExt":22,"email":95},{"name":117,"role":93,"phone":118,"phoneExt":22,"email":95},{"name":135,"role":121,"phone":22,"phoneExt":22,"email":22},"Thomas Cotter",{"facility":101,"status":102,"city":137,"state":124,"zip":138,"country":106,"countryCode":107,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"San Antonio","78215",{"type":109,"coordinates":140},[141,142],-98.49363,29.42412,{"lat":142,"lon":141},[145,146,147],{"name":92,"role":93,"phone":94,"phoneExt":22,"email":95},{"name":117,"role":93,"phone":118,"phoneExt":22,"email":95},{"name":148,"role":121,"phone":22,"phoneExt":22,"email":22},"Eric Lawitz",{"facility":101,"status":102,"city":150,"state":22,"zip":151,"country":152,"countryCode":153,"cosmosGeoPoint":22,"geoPoint":22,"contacts":154},"CABA","C1056ABI","Argentina","AR",[155,156,157],{"name":92,"role":93,"phone":94,"phoneExt":22,"email":95},{"name":117,"role":93,"phone":118,"phoneExt":22,"email":95},{"name":158,"role":121,"phone":22,"phoneExt":22,"email":22},"Maria Anders",{"type":160,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100653768","phase-2-a-study-to-investigate-the-safety-and-efficacy-of-efimosfermin-alfa-compared-with-placebo-in-adult-participants-with-alcohol-related-liver-disease-ald-100653768",false,"NCT07791043","A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)","A Dose-finding, Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Treatment With Efimosfermin Alfa in Adult Participants With Alcohol-related Liver Disease (ALD)","ALLSTAR","Inclusion Criteria:\n\n* Participant must be 18 to 75 years of age inclusive, at the time of Screening.\n* Capable of giving signed informed consent prior to the performance of any study-specific procedures.\n* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.\n* History of heavy alcohol consumption for greater than 6 months at any time prior to Screening.\n* A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:\n\n  * Is a Participant of non-childbearing potential (PONCBP) OR\n  * Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C)1 percentage (%), 30 days prior to and during the study intervention period and for at least 16 weeks after the last dose of study intervention.\n\nExclusion Criteria:\n\n* Other primary causes of liver disease (e.g., viral hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, alpha-1-antitryspin deficiency, etc.). Alcohol must be the primary cause of liver disease.\n* Co-infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) as indicated from the central lab\n* History of diabetes mellitus (DM), either:\n\n  * Type 1 DM\n  * Type 2 DM with unstable glycemic control or with major complications.\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the 3 years prior to Screening 1, regardless of any evidence of local recurrence or metastasis.\n* Current, or history of known hepatocellular carcinoma (HCC).\n* Any major surgery within 3 months prior to Screening 1 or planned during the study\n* Any surgical or medical condition that might jeopardize the individual's safety or compliance with study procedures in the opinion of the investigator.\n* All organ transplant recipients, except for history of corneal transplants, or current listing or active consideration for liver transplant during the Screening period.\n* Poorly controlled hypertension.\n* Evidence of Wernicke-Korsakoff syndrome or alcohol-related dementia.\n* Prior use of a Fibroblast growth factor 21 (FGF21) analogue, including efimosfermin, within the 6 months prior to Screening 1.\n* Individuals with a history of resmetirom use within 3 months prior to Day 1 are to be excluded.\n* Concomitant use of investigational drugs for Metabolic dysfunction-associated steatohepatitis (MASH) or ALD.\n* Current or planned participation in any clinical trial of investigational therapies or medical devices.\n* Exceeding pre-defined laboratory parameters for Triglycerides, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), International normalised ratio (INR), Albumin, Urine albumin-creatinine ratio (uACR) or Glycosylated Hemoglobin (HbA1c).\n* History of drug abuse within the 12 months prior to Day 1 or evidence of such abuse as indicated by laboratory assays conducted at Screening.\n* History of hypersensitivity (such as anaphylaxis or hepatotoxicity) to study intervention and\u002For its excipients, drugs of similar biological class, FGF21 protein analogs, Fc-fusion proteins, or other protein-based therapeutics.\n* Overt hepatic encephalopathy (West Haven grade \\>=2).","ALL","18 Years","75 Years",{"count":173,"type":174},274,"ESTIMATED","INTERVENTIONAL",[177],"PHASE2","This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.",[180],"Liver Diseases, Alcoholic",[80,182,183,184],"Alcohol-related liver disease","Liver stiffness measurement","Advanced chronic liver disease","2026-09-29",{"date":187,"type":188},"2026-09-30","ACTUAL",{"date":190,"type":188},"2026-08-31",{"date":192,"type":174},"2030-01-14",{"name":5,"class":6},4]