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Study of efimosfermin alfa versus placebo in adults with compensated cirrhosis from metabolic dysfunction-associated steatohepatitis (MASH)

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What is this trial about?

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

The study focuses on adults who have Metabolic dysfunction-associated steatohepatitis that has progressed to compensated cirrhosis, a condition where the liver is scarred but still performs most of its normal functions. Participants will receive a subcutaneous injection of the investigational drug efimosfermin alfa or a placebo that looks the same but does not contain the active medicine.

The main aim of the trial is to see how long it takes for a serious liver‑related health event to occur in people taking the new drug compared with those receiving the placebo. After random assignment, participants will attend regular clinic visits where the injection is given, safety checks are performed, and simple questionnaires about health and well‑being are completed over several months.

Terms used in the description are explained in plain language: “steatohepatitis” means inflammation of the liver caused by excess fat, and “cirrhosis” refers to scarring of the liver tissue. “Compensated” indicates that, despite scarring, the liver can still carry out its essential jobs. The injection is administered just under the skin, similar to a routine insulin shot. The study will monitor how participants feel and any side effects that may appear.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Assignment

    After you join the study, you will be randomly assigned to receive either efimosfermin alfa or a placebo. The assignment is done by the study system and you will not know which one you receive.

  2. Step 2

    Baseline Assessments

    Before the first dose, you will undergo a series of baseline tests. These include blood tests, imaging of the liver (such as vibration‑controlled transient elastography and magnetic resonance elastography), and questionnaires that ask about your fatigue and quality of life.

    The purpose of these tests is to record your health status before treatment starts.

  3. Step 3

    First Injection

    You will receive the study medication as a subcutaneous injection (injection under the skin). The medication is supplied as a powder that is mixed with a liquid to create the injection solution.

    The exact amount of the dose and the frequency of injections are defined by the study protocol; this information is provided to you by the study staff.

  4. Step 4

    Ongoing Injections

    You will continue to receive injections according to the study schedule. Each injection is given at the clinic under the supervision of study personnel.

    The duration of treatment lasts for the full length of the trial, which continues until the final study visit.

  5. Step 5

    Regular Follow‑up Visits

    At scheduled intervals, you will return to the clinic for follow‑up visits. During these visits you will have repeat blood tests, liver imaging (VCTE and MRE), and complete the same questionnaires you filled out at baseline.

    These assessments allow the study to evaluate changes in liver stiffness, fibrosis scores, blood sugar control, cholesterol levels, and your overall well‑being.

  6. Step 6

    Safety Monitoring

    Throughout the trial you will be monitored for any side effects, called treatment‑emergent adverse events (TEAEs). The study team will ask you about symptoms at each visit and may perform additional laboratory checks if needed.

    If a side effect is severe, the study protocol may allow you to stop the medication.

  7. Step 7

    End‑of‑Study Visit

    When the study period ends, you will attend a final visit. This visit includes the last set of blood tests, liver imaging, and questionnaires.

    The information collected at this visit is used to determine the overall effect of the treatment compared with the placebo.

Who can join the trial?

3 criteria

  • Be between 18 and 75 years old at the time you join the study.
  • Have compensated cirrhosis caused by MASH (Metabolic dysfunction‑associated steatohepatitis), which means the liver is scarred but still works well enough, and this must be shown by non‑invasive assessments (tests that do not require surgery, such as imaging or blood tests).
  • Have a history or current presence of at least two components of metabolic syndrome, which includes conditions like high blood pressure, high blood sugar, excess belly fat, abnormal cholesterol levels, or low “good” cholesterol.

Who cannot join the trial?

7 criteria

  • Having other chronic liver diseases (long‑term liver problems that are not the study disease).
  • Having signs or a past history of decompensated liver disease (advanced liver failure) or hepatocellular carcinoma (a type of liver cancer).
  • Having a history of Type 1 diabetes or serious complications from Type 2 diabetes (such as kidney or eye damage).
  • Having a history or evidence of chronic pancreatic disease, damage to the pancreas, or an episode of acute pancreatitis (sudden inflammation of the pancreas) within the past 6 months.
  • Having recently had, or planning, surgical procedures or taking medicines that are intended to cause major weight loss.
  • Having liver enzyme levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that are five times higher than the normal upper limit (a sign of significant liver injury).
  • Having a current or past history of excessive alcohol intake.
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Investigated drugs

Efimosfermin alfa is the experimental medicine being tested in this study. It is given as a powder that is mixed with liquid and injected under the skin (subcutaneous injection). The drug is being evaluated to see if it can safely improve liver health and prevent worsening of cirrhosis in adults who have compensated cirrhosis caused by metabolic dysfunction‑associated steatohepatitis. Researchers will compare how well participants do on this medication versus those who receive a placebo, looking at how long it takes for serious liver‑related problems to occur.

What is already known about the treatment

EFIMOSFERMIN ALFA - Efimosfermin alfa is supplied as a powder that is mixed with liquid and injected under the skin (subcutaneous injection). It is currently an investigational medicine being tested in a Phase 3 trial and is not yet approved for general use. The drug is being studied to treat adults with metabolic dysfunction‑associated steatohepatitis and compensated cirrhosis. It works by mimicking a natural protein called fibroblast growth factor‑19, binding to liver receptors to lower bile‑acid production and improve how the liver handles fats and sugars, and it belongs to the class of FGF‑19 analogs used for metabolic disease.

Investigated diseases

Metabolic dysfunction-associated steatohepatitis - This condition involves the buildup of fat in the liver together with inflammation and damage to liver cells. It often starts as simple fatty liver and can advance to a state where scar tissue forms. Over time, the scarring can become more extensive, leading to a firmer, less functional liver. The disease may progress quietly, with symptoms appearing only as the liver changes. Lifestyle factors such as excess weight and insulin resistance commonly drive its development.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525755-82-00Protocol code306300Estimated enrolment1 598 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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