Can a new drug repair livers damaged by alcohol?
NCT ID NCT07791043
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This phase 2 trial tests an experimental drug called efimosfermin alfa in adults with alcohol-related liver disease. The study aims to see if the drug can improve liver health, measured by liver stiffness and a standard liver disease severity score. Participants receive either the drug or a placebo, and researchers compare changes over time. The trial includes about 274 adults aged 18 to 75 with a history of heavy drinking.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Efimosfermin alfa, an experimental drug, given as an injection or infusion.
- What this could lead to
- If it works, this could lead to a new treatment that slows or reverses liver damage in people with alcohol-related liver disease.
- What could go wrong
- This is an early phase 2 study, so the drug may not work or may cause side effects. The results will need confirmation in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 274 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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