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Safety and Efficacy of Efimosfermin Alfa vs Placebo in Adults with Alcohol-Related Liver Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on adults who have Alcohol-related Liver Disease, a condition where long‑term drinking damages the liver. The investigational medication being tested is efimosfermin alfa, which is given as a powder that is mixed with liquid and injected under the skin. A matching inactive product, called a placebo, is also used so that participants receive either the active drug or the inactive substance without knowing which one they receive.

The purpose of the study is to determine whether the drug can lower liver stiffness and improve overall liver health. Participants will receive a series of injections over several months and will attend regular clinic visits. During these visits doctors will perform a non‑invasive scan called a FibroScan that uses sound waves to assess how firm the liver is, referred to as VCTE‑LSM, and will calculate a MELD score, a number based on blood tests that indicates the severity of liver disease. The study is designed so that neither the participants nor the researchers know who receives the drug or the placebo, and participants are assigned to groups at random.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessment

    You undergo a liver stiffness measurement called FibroScan (VCTE‑LSM) to establish a starting value.

    Blood samples are taken to calculate the MELD score, which reflects liver function.

  2. Step 2

    Randomization

    You are randomly assigned, in a double‑blind manner, to receive either efimosfermin alfa or a matching placebo.

    Neither you nor the study staff know which product you receive.

  3. Step 3

    First Injection

    A subcutaneous injection of the assigned product is given.

    The product is supplied as a powder for solution for injection and is prepared by the study team.

    The dose is defined by the study protocol (dose amount not disclosed here).

  4. Step 4

    Repeated Injections

    You continue to receive the same subcutaneous injection at regular intervals for the duration of the study, as directed by the protocol.

    The frequency (for example, weekly or monthly) is specified by the study schedule.

  5. Step 5

    Periodic Liver Assessments

    At each scheduled visit you have another FibroScan to measure any change in liver stiffness.

    Blood tests are repeated to update the MELD score.

  6. Step 6

    Safety Monitoring

    You are asked to report any new symptoms or side effects.

    Study staff may perform additional examinations or laboratory tests to ensure safety.

  7. Step 7

    End‑of‑Treatment Visit

    The final injection of the assigned product is administered.

    A final FibroScan and blood draw for the MELD score are performed to evaluate the overall effect.

  8. Step 8

    Post‑Treatment Follow‑up

    A follow‑up visit is scheduled after the last dose to check for any delayed side effects.

    No further study medication is given.

Who can join the trial?

7 criteria

  • Participant must be between 18 and 75 years old at the time of screening.
  • Participant must be able to sign a written informed consent (a document that shows they understand and agree to the study) before any study procedures are done.
  • Participant must be willing and able to follow all study visits, tests, and the scheduled timetable (protocol schedule of activities).
  • Female participants must not be pregnant or breastfeeding.
  • Female participants must either belong to a study‑defined group called PONCBP or belong to a group called POCBP and use a highly effective contraceptive method (a birth‑control method that fails less than <1% of the time), starting at least 30 days before the first dose and continuing during and after treatment.
  • Women who are in the POCBP group must have a negative highly sensitive pregnancy test (urine or blood test) right before randomization and before receiving the first dose of the study drug.
  • The study doctor will review the participant’s medical history, menstrual history, and recent sexual activity to reduce the chance of including anyone with an early, undetected pregnancy.

Who cannot join the trial?

24 criteria

  • Having signs of Wernicke‑Korsakoff syndrome (a brain disorder caused by severe lack of vitamin B1) or alcohol‑related memory loss means you cannot join.
  • If your HbA1c level (a blood test that shows average blood sugar over the past 3 months) is too high, you are excluded.
  • A high level of ALT (an enzyme that indicates liver cell injury) will prevent participation.
  • If you have another main cause of liver disease such as viral hepatitis, autoimmune hepatitis, drug‑induced liver damage, Wilson disease, hemochromatosis, alpha‑1‑antitrypsin deficiency, or similar conditions, you cannot join because alcohol‑related liver disease must be the primary problem.
  • A high level of ALP (another liver enzyme) is an exclusion reason.
  • Being infected at the same time with hepatitis B (HBV), hepatitis C (HCV), or HIV excludes you.
  • Having a history of diabetes (DM), whether type 1 or type 2 with poor blood‑sugar control or serious complications, makes you ineligible.
  • Current or past diagnosis of liver cancer called hepatocellular carcinoma (HCC) excludes you.
  • Low levels of serum albumin (a protein that reflects nutrition and liver function) are not allowed.
  • A high INR (a test that measures how quickly your blood clots) will disqualify you.
  • Any drug abuse within the 12 months before the study, or evidence of such use in screening tests, means you cannot participate.
  • Using other experimental medicines for MASH (metabolic dysfunction‑associated steatohepatitis) or alcohol‑related liver disease at the same time excludes you.
  • Having a serious allergic reaction (such as anaphylaxis) or liver toxicity to the study drug, similar drugs, or related protein therapies prevents enrollment.
  • Having overt hepatic encephalopathy (brain dysfunction caused by liver failure) that is grade 2 or higher on the West Haven scale excludes you.
  • Any cancer (other than a small skin basal cell carcinoma or early‑stage cervical cancer) diagnosed or treated within the past 3 years makes you ineligible.
  • If you used any FGF21 analogue, including efimosfermin, within the 6 months before screening, you cannot join.
  • Use of the drug resmetirom within the 3 months before the study excludes you.
  • Having major surgery within the past 3 months, or planning major surgery during the study, will disqualify you.
  • Any medical or surgical condition that the doctor believes could put your safety at risk or make it hard to follow study procedures excludes you.
  • Being an organ transplant recipient (except for a corneal transplant) or being listed for a liver transplant during screening makes you ineligible.
  • Having high blood pressure that is not well controlled excludes you.
  • Being currently involved in, or planning to join, another clinical trial of experimental treatments or devices prevents participation.
  • A high urinary albumin‑to‑creatinine ratio (uACR, a kidney test) is an exclusion criterion.
  • Having high blood triglycerides (a type of fat) also excludes you.
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Investigated drugs

EFIMOSFERMIN ALFA is a medication given as a powder that is mixed with liquid and injected under the skin. In this study, it is being tested to see if it can help adults with alcohol‑related liver disease. Researchers are looking to find out whether the medicine can lower the liver’s stiffness and improve the liver’s overall health, which is measured by specific scores doctors use to track liver disease. The trial is designed to compare people who receive EFIMOSFERMIN ALFA with those who receive a placebo, but only the description of EFIMOSFERMIN ALFA is provided here.

What is already known about the treatment

EFIMOSFERMIN ALFA - This medication is given as a powder that is mixed with liquid and injected under the skin (subcutaneous use). It is an experimental drug that is currently being studied in clinical trials and has not yet received market approval. The main purpose being tested is to treat alcoholic liver disease by helping the liver process fats and sugars more normally. It works by acting like a natural protein called fibroblast growth factor‑21, which tells liver cells to reduce fat buildup and improve metabolism, and it is classified as a synthetic metabolic modulator.

Investigated diseases

Alcoholic Liver Disease - Alcoholic liver disease is a condition caused by long‑term excessive alcohol consumption that damages liver cells. Over time the liver develops inflammation and scarring, which can reduce its ability to process nutrients and toxins. The disease often begins with fatty accumulation in liver cells, progresses to inflammation (hepatitis), and may further advance to fibrotic tissue formation. As scar tissue builds up, the liver becomes less flexible and its function declines. In later stages, the liver may become hardened and develop complications such as fluid buildup in the abdomen.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526391-23-00Protocol code306837Estimated enrolment214 patientsSponsorGlaxosmithkline Research & Development Limited

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