A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
GlaxoSmithKline · NCT07791043
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 274
- US sites recruiting
- 3
- Study start
- August 31, 2026
- Record last updated
- September 30, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Efimosfermin alfa; Placebo
Conditions: Liver Diseases, Alcoholic
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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).
Recruiting US locations
GSK Investigational Site
Topeka, KS 66606
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Fort Worth, TX 76104
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
San Antonio, TX 78215
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
Study contacts (from the official record)
- US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Center · +44 (0) 20 89904466 · GSKClinicalSupportHD@gsk.com