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Experimental drug aims to stop liver failure in MASH cirrhosis

NCT ID NCT07701993

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Sep 09, 2026 · Updated 4 times

Summary

This phase 3 study tests whether an experimental drug called efimosfermin alfa can prevent serious liver complications in adults with compensated cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis). Participants receive either the drug or a placebo as a shot under the skin. The main goal is to see if the drug reduces the risk of death, need for liver transplant, or liver decompensation events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called efimosfermin alfa, given as a subcutaneous injection
What this could lead to
If successful, this could become the first approved treatment to prevent liver failure, need for transplant, or death in people with MASH-related cirrhosis.
What could go wrong
This is a large phase 3 trial, but the drug is still experimental. It may not prove effective or could have side effects that outweigh benefits. Results will take years.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,740 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2033

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants aged between 18 and 75 years at enrollment. * Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments. * Participants with history or presence of at least two components of metabolic syndrome. Exclusion Criteria: * Participants with other chronic liver diseases. * Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma. * Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications. * Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening. * Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss. * Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5 times upper limit normal (ULN). * Participants with current or history of excessive alcohol intake.

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Conditions

The condition(s) this trial relates to.

fatty liver disease Fibrosis metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic dysfunction-associated steatohepatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33135-4661, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33155, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75243-1921, United States

  • GSK Investigational Site

    RECRUITING

    Humble, Texas, 77346, United States

  • GSK Investigational Site

    RECRUITING

    San Antonio, Texas, 78215, United States

  • GSK Investigational Site

    RECRUITING

    Kawasaki-shi, 215-0026, Japan

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