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A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
RecruitingPhase 2
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)
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * Participant must be 18 to 75 years of age inclusive, at the time of Screening. * Capable of giving signed informed consent prior to the performance of any study-specific procedures. * Able and willing to comply with all study assessments and adhere to the protocol schedule of activities. * History of heavy alcohol consumption for greater than 6 months at any time prior to Screening. * A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies: * Is a Participant of non-childbearing potential (PONCBP) OR * Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<)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. Exclusion Criteria: * 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. * Co-infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) as indicated from the central lab * History of diabetes mellitus (DM), either: * Type 1 DM * Type 2 DM with unstable glycemic control or with major complications. * 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. * Current, or history of known hepatocellular carcinoma (HCC). * Any major surgery within 3 months prior to Screening 1 or planned during the study * Any surgical or medical condition that might jeopardize the individual's safety or compliance with study procedures in the opinion of the investigator. * All organ transplant recipients, except for history of corneal transplants, or current listing or active consideration for liver transplant during the Screening period. * Poorly controlled hypertension. * Evidence of Wernicke-Korsakoff syndrome or alcohol-related dementia. * Prior use of a Fibroblast growth factor 21 (FGF21) analogue, including efimosfermin, within the 6 months prior to Screening 1. * Individuals with a history of resmetirom use within 3 months prior to Day 1 are to be excluded. * Concomitant use of investigational drugs for Metabolic dysfunction-associated steatohepatitis (MASH) or ALD. * Current or planned participation in any clinical trial of investigational therapies or medical devices. * 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). * 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. * History of hypersensitivity (such as anaphylaxis or hepatotoxicity) to study intervention and/or its excipients, drugs of similar biological class, FGF21 protein analogs, Fc-fusion proteins, or other protein-based therapeutics. * Overt hepatic encephalopathy (West Haven grade \>=2).
About the study
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.
What is being tested
- Efimosfermin alfa (drug)
- Placebo (drug)
Sponsor: GlaxoSmithKline · Participants: 274 · Started: Aug 31, 2026
Contact the study team
- US GSK Clinical Trials Call Center · Phone: 877-379-3718
- EU GSK Clinical Trials Call Center · Phone: +44 (0) 20 89904466
Official record on ClinicalTrials.gov — NCT07791043
Locations in the U.S.
| Kansas | GSK Investigational Site, Topeka |
| Texas | GSK Investigational Site, Fort Worth GSK Investigational Site, San Antonio |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.