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New drug hopes to halt liver damage in MASH patients

NCT ID NCT07221188

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This phase 3 trial tests a drug called efimosfermin alfa in 1250 adults with MASH (a fatty liver disease) and moderate liver scarring. The main goal is to check safety and side effects. Participants will receive either the drug or a placebo, and researchers will monitor liver health over time.

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
What this could lead to
If successful, this could point toward a treatment that slows or stops liver damage in people with MASH and fibrosis.
What could go wrong
This is an early-stage safety trial, so it may not prove the drug works. Side effects or lack of benefit could stop development.

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 1,250 people

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

Started

Dec 2025

Expected to finish

Mar 2028

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: * Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures * Age \>=18 through \<=75 years at enrolment * History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition * History or presence of known or suspected MASH with evidence of fibrosis Exclusion Criteria: * ALT or AST \>=5 × upper limit of normal (ULN) * Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \>=1.3 mg/dL and direct BILI is \<=20% of total BILI; otherwise, the individual will be excluded. * Serum albumin \<=3.5 grams per deciliter (g/dL) * International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor. * Alkaline phosphatase (ALP) \>=2 × ULN * Platelet (PLT) count \<140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor * Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation. * Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL) * HbA1c \>=9.0% * Model for End-Stage Liver Disease (MELD) 3.0 score \>=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome) * Phosphatidylethanol (PEth) \>=80 nanogram per milliliter (ng/mL) at Screening * Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. Hepatitis C virus (HCV); d. Hepatitis D virus; or e. Hepatitis E virus. * Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1. * Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Non-alcoholic fatty liver disease

How to take part

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

  1. The places running it

    66 sites in 8 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

    Arcadia, California, 91006, United States

  • GSK Investigational Site

    RECRUITING

    Covina, California, 91723, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90057, United States

  • GSK Investigational Site

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    San Diego, California, 92120, United States

  • GSK Investigational Site

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    Santa Maria, California, 93458, United States

  • GSK Investigational Site

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    Van Nuys, California, 91405, United States

  • GSK Investigational Site

    RECRUITING

    Boynton Beach, Florida, 33435-5610, United States

  • GSK Investigational Site

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    Cape Coral, Florida, 33914, United States

  • GSK Investigational Site

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    Clermont, Florida, 34711, United States

  • GSK Investigational Site

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    Doral, Florida, 33016, United States

  • GSK Investigational Site

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    Fort Myers, Florida, 33912, United States

  • GSK Investigational Site

    RECRUITING

    Hialeah, Florida, 33016, United States

  • GSK Investigational Site

    RECRUITING

    Homestead, Florida, 33033, United States

  • GSK Investigational Site

    RECRUITING

    Inverness, Florida, 34452, United States

  • GSK Investigational Site

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • GSK Investigational Site

    RECRUITING

    Kissimmee, Florida, 34744, United States

  • GSK Investigational Site

    RECRUITING

    Lakeland, Florida, 33803, United States

  • GSK Investigational Site

    RECRUITING

    Maitland, Florida, 32751, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33135-4661, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33144, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33155, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33156-7397, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33173-3484, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33184, United States

  • GSK Investigational Site

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    Miami Lakes, Florida, 33014, United States

  • GSK Investigational Site

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    Ocala, Florida, 34471, United States

  • GSK Investigational Site

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    Palmetto Bay, Florida, 33157, United States

  • GSK Investigational Site

    RECRUITING

    Sarasota, Florida, 34201, United States

  • GSK Investigational Site

    RECRUITING

    Topeka, Kansas, 66606, United States

  • GSK Investigational Site

    RECRUITING

    Marrero, Louisiana, 70072, United States

  • GSK Investigational Site

    RECRUITING

    Springfield, Missouri, 62703, United States

  • GSK Investigational Site

    RECRUITING

    St Louis, Missouri, 63123, United States

  • GSK Investigational Site

    RECRUITING

    St Louis, Missouri, 63141, United States

  • GSK Investigational Site

    RECRUITING

    Jersey City, New Jersey, 07059, United States

  • GSK Investigational Site

    RECRUITING

    East Syracuse, New York, 13057, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10036-4103, United States

  • GSK Investigational Site

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • GSK Investigational Site

    RECRUITING

    Akron, Ohio, 44320, United States

  • GSK Investigational Site

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    Springboro, Ohio, 45066, United States

  • GSK Investigational Site

    RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • GSK Investigational Site

    RECRUITING

    Austin, Texas, 78745-5675, United States

  • GSK Investigational Site

    RECRUITING

    Austin, Texas, 78759, United States

  • GSK Investigational Site

    RECRUITING

    Brownsville, Texas, 78526, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75243, United States

  • GSK Investigational Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • GSK Investigational Site

    RECRUITING

    Richmond, Texas, 77406, United States

  • GSK Investigational Site

    RECRUITING

    San Antonio, Texas, 78209, United States

  • GSK Investigational Site

    RECRUITING

    San Antonio, Texas, 78215, United States

  • GSK Investigational Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    RECRUITING

    Seabrook, Texas, 77586, United States

  • GSK Investigational Site

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • GSK Investigational Site

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • GSK Investigational Site

    RECRUITING

    Tomball, Texas, 77375, United States

  • GSK Investigational Site

    RECRUITING

    Waco, Texas, 76710, United States

  • GSK Investigational Site

    RECRUITING

    Waco, Texas, 76712, United States

  • GSK Investigational Site

    RECRUITING

    West Jordan, Utah, 84088, United States

  • GSK Investigational Site

    RECRUITING

    Manassas, Virginia, 20110, United States

  • GSK Investigational Site

    RECRUITING

    Seattle, Washington, 98105, United States

  • GSK Investigational Site

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • GSK Investigational Site

    RECRUITING

    Paris, 75651, France

  • GSK Investigational Site

    RECRUITING

    Leipzig, 04103, Germany

  • GSK Investigational Site

    RECRUITING

    Pokfulam, Hong Kong

  • GSK Investigational Site

    RECRUITING

    Gunma, 370-0829, Japan

  • GSK Investigational Site

    RECRUITING

    Kagoshima, 890-8520, Japan

  • GSK Investigational Site

    RECRUITING

    Wellington, 6021, New Zealand

  • GSK Investigational Site

    RECRUITING

    Riyadh, 11472, Saudi Arabia

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