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Safety and efficacy of efimosfermin alfa versus placebo in adults with compensated cirrhosis (stage F4) due to 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 advanced liver scarring known as compensated cirrhosis caused by Metabolic dysfunction-associated steatohepatitis (a condition where excess fat and inflammation damage the liver). The treatment being tested is a medication called efimosfermin alfa, which is given as a powder that is mixed and injected under the skin (subcutaneous injection). Participants will receive either this medication or a placebo, which looks the same but does not contain the active drug.

The purpose of the study is to find out whether efimosfermin alfa can improve the liver’s scarring by at least one stage without making the disease worse. In this late‑stage trial, participants are randomly assigned to receive either the drug or the placebo, and neither the participants nor the study staff know which one is given. Over several months, participants will attend regular clinic visits where doctors will check their health, monitor any side effects, and perform simple tests such as a scan that measures how stiff the liver is (liver stiffness measurement) and blood tests that look at liver health. The study follows participants for a defined period to see how well the medication works and how safe it is.

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

    Enrollment and Consent

    You join the study and sign an informed consent form that explains the purpose, procedures, and your rights.

    Your participation is voluntary, and you may withdraw at any time.

  2. Step 2

    Randomization

    You are randomly assigned to receive either efimosfermin alfa or a placebo. The assignment is double‑blind, meaning neither you nor the study staff know which treatment you receive.

  3. Step 3

    Baseline Assessments

    Before any medication is given, you undergo a series of tests to record your starting condition:

    Blood tests to check liver function and other health markers.

    Vibration Controlled Transient Elastography (VCTE), a painless ultrasound that measures liver stiffness.

    Enhanced Liver Fibrosis (ELF) score, a blood‑based test that assesses liver scarring.

  4. Step 4

    Start of Treatment

    You receive a subcutaneous (under the skin) injection of either efimosfermin alfa or the placebo.

    The medication is supplied as a powder for solution for injection and is prepared according to the study protocol.

    The dose listed in the protocol is 0 mg; the exact amount and schedule are defined by the study investigators.

  5. Step 5

    Regular Study Visits

    You attend scheduled clinic visits throughout the trial.

    At each visit you may receive another injection, have blood drawn for safety labs, and repeat the VCTE and ELF assessments to track changes in your liver.

    The frequency of visits follows the study schedule.

  6. Step 6

    Safety Monitoring

    Study staff monitor you for any treatment‑emergent adverse events (TEAEs), which are side effects that appear after you start the medication.

    All adverse events are recorded, graded for severity, and reported to the study team.

  7. Step 7

    Evaluation of Fibrosis Improvement

    At the end of Part A of the study, your liver fibrosis is re‑evaluated using VCTE and ELF scores.

    The primary goal is to determine whether there is an improvement of at least one fibrosis stage without worsening of MASH (metabolic dysfunction‑associated steatohepatitis).

  8. Step 8

    Study Completion

    After the final assessments, the study concludes for you.

    All collected data are analyzed to compare the effects of efimosfermin alfa with the placebo.

Who can join the trial?

4 criteria

  • Must be between 18 and 75 years old at the time of enrollment.
  • Must have a history or current presence of at least two of the conditions that make up metabolic syndrome (for example, high blood pressure, high blood sugar, excess belly fat, or abnormal cholesterol levels).
  • Must have had a liver biopsy (a small sample of liver tissue taken with a needle and examined under a microscope) that shows cirrhosis – the most severe form of liver scarring, known as fibrosis stage 4.
  • Both men and women are eligible to participate.

Who cannot join the trial?

7 criteria

  • Having any other chronic liver disease, which means a long‑lasting liver problem that is not the one being studied.
  • Having signs of or a past history of decompensated liver disease (severe liver failure) or hepatocellular carcinoma (a type of liver cancer).
  • Having Type 1 diabetes or major complications from Type 2 diabetes (serious health problems caused by this form of diabetes).
  • Having a long‑term pancreatic disease, injury to the pancreas, or an episode of acute pancreatitis (sudden inflammation of the pancreas) within the past six months.
  • Having had recent weight‑loss surgery or taking medicines that are meant to cause a large amount of weight loss.
  • Having liver enzyme levels called ALT or AST that are five times higher than the normal upper limit, which indicates significant liver injury.
  • Currently drinking a lot of alcohol or having a history of excessive alcohol intake.
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Investigated drugs

EFIMOSFERMIN ALFA is a medication being tested in this study. It is given as a powder that is mixed with liquid and then injected under the skin (subcutaneous injection). The drug is designed to work on the liver by helping to reduce the amount of scar tissue (fibrosis) that builds up in people who have advanced liver scarring (stage F4 fibrosis) caused by a condition called metabolic dysfunction‑associated steatohepatitis (MASH). In the trial, participants receive EFIMOSFERMIN ALFA to see if it can improve their liver condition by at least one stage of fibrosis without making the disease worse. The medication is being compared to a placebo to determine its safety and how well it works for this purpose.

What is already known about the treatment

  • Placebo for Efimosfermin alfa

    The placebo is a powder that is prepared like the active drug but contains no efimosfermin alfa, and it is given by subcutaneous injection in the same way as the test product. It is used only as an inactive control in clinical trials and has no approved medical use or presence in drug references. Its purpose is to help researchers see whether the active medication produces real benefits compared with no treatment. As an inert substance, it has no therapeutic effect, mechanism of action, or pharmacologic class.

  • EFIMOSFERMIN ALFA

    Efimosfermin alfa is a powder that is mixed with a liquid and injected under the skin (subcutaneous injection). It is an experimental drug currently in Phase 3 studies for adults with compensated cirrhosis caused by metabolic dysfunction‑associated steatohepatitis (MASH). The medication works by mimicking a natural protein that helps the liver break down fats and reduces the formation of scar tissue. It is classified as a recombinant fusion protein that acts like a fibroblast growth factor analog.

Investigated diseases

Metabolic dysfunction-associated steatohepatitis - It is a chronic liver condition in which excess fat builds up in liver cells, accompanied by inflammation and damage. The disease often starts as simple fatty liver and can progress to a stage where scar tissue forms in the liver. Over time, the scar tissue may become more extensive, leading to advanced fibrosis. The ongoing inflammation and fibrosis can further impair the liver’s ability to function normally. This progression occurs gradually and can vary in speed among individuals.
Trial detailsLast updated 15 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525757-37-00Protocol code308623Estimated enrolment358 patientsSponsorGlaxosmithkline Research & Development Limited

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