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New drug aims to reverse liver damage in MASH patients

NCT ID NCT07221227

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether efimosfermin alfa can improve liver scarring and reduce inflammation in people with MASH (a type of fatty liver disease). About 1,200 adults with moderate-to-severe liver fibrosis will receive the drug or a placebo for 52 weeks. The goal is to see if the drug can reverse liver damage and prevent serious liver complications.

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 drug could become a treatment that reverses liver scarring and prevents liver failure in people with MASH.
What could go wrong
This is a large Phase 3 trial, but the drug is still experimental. It may not work better than placebo, and side effects are possible. Results are expected after 52 weeks.

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 1,200 people

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

Started

Oct 2025

Expected to finish

Dec 2031

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: 1. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures 2. Age \>=18 and \<=75 years at enrollment 3. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition 4. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist Exclusion Criteria: 1. Contraindication or ineligibility for percutaneous liver biopsy 2. ALT or AST \>=5 x upper limit of normal (ULN) 3. Total bilirubin \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of \>=1.3 mg/dL and direct bilirubin is \<=20% of total bilirubin; otherwise, the individual will be excluded. 4. Serum albumin \<=3.5 grams per deciliter (g/dL) 5. 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. 6. Alkaline phosphatase (ALP) \>=2\*ULN 7. 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. 8. 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 9. Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL) 10. Glycated hemoglobin \>=9.0% 11. Model for End-Stage Liver Disease score \>=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome) 12. Phosphatidyl ethanol (PEth) \>=80 ng/mL at Screening 13. Evidence of infection with any of the following: 1. Human immunodeficiency virus; 2. Hepatitis B virus (detectable HBsAg at Screening); 3. Hepatitis C virus (HCV); 14. 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 on screening liver biopsy; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1. 15. 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

    91 sites in 9 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

    Chandler, Arizona, 85224, United States

  • GSK Investigational Site

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    Tucson, Arizona, 85712, United States

  • GSK Investigational Site

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    Little Rock, Arkansas, 72211, United States

  • GSK Investigational Site

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    Arcadia, California, 91006, United States

  • GSK Investigational Site

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    Covina, California, 91723, United States

  • GSK Investigational Site

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    Folsom, California, 95630, United States

  • GSK Investigational Site

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    Los Angeles, California, 90057, United States

  • GSK Investigational Site

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    Montclair, California, 91763, United States

  • GSK Investigational Site

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    Riverdale, California, 30274, 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

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    Colorado Springs, Colorado, 80907, United States

  • GSK Investigational Site

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    Boynton Beach, Florida, 33435, 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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    Fort Myers, Florida, 33912, United States

  • GSK Investigational Site

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    Hialeah, Florida, 33016, United States

  • GSK Investigational Site

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    Hialeah, Florida, 33016, United States

  • GSK Investigational Site

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    Homestead, Florida, 33033, United States

  • GSK Investigational Site

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    Inverness, Florida, 34452, United States

  • GSK Investigational Site

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    Jacksonville, Florida, 32216, United States

  • GSK Investigational Site

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    Kissimmee, Florida, 34744, United States

  • GSK Investigational Site

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    Lakeland, Florida, 33803, United States

  • GSK Investigational Site

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    Maitland, Florida, 32751, United States

  • GSK Investigational Site

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    Miami, Florida, 33135, United States

  • GSK Investigational Site

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    Miami, Florida, 33144, United States

  • GSK Investigational Site

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    Miami, Florida, 33155, United States

  • GSK Investigational Site

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    Miami, Florida, 33156, United States

  • GSK Investigational Site

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    Miami, Florida, 33173, United States

  • GSK Investigational Site

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    Miami, Florida, 33176, United States

  • GSK Investigational Site

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    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

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    Sarasota, Florida, 34201, United States

  • GSK Investigational Site

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    Marietta, Georgia, 30060, United States

  • GSK Investigational Site

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    Topeka, Kansas, 66606, United States

  • GSK Investigational Site

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    Bastrop, Louisiana, 71220, United States

  • GSK Investigational Site

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    Marrero, Louisiana, 70072, United States

  • GSK Investigational Site

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    Kansas City, Missouri, 64131, United States

  • GSK Investigational Site

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    Springfield, Missouri, 62703, United States

  • GSK Investigational Site

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    St Louis, Missouri, 63141, United States

  • GSK Investigational Site

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    Las Vegas, Nevada, 89106, United States

  • GSK Investigational Site

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    East Syracuse, New York, 13057, United States

  • GSK Investigational Site

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    New York, New York, 10036, United States

  • GSK Investigational Site

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    New York, New York, 10036, United States

  • GSK Investigational Site

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    Fayetteville, North Carolina, 28304, United States

  • GSK Investigational Site

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    Morehead City, North Carolina, 28557, United States

  • GSK Investigational Site

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    Akron, Ohio, 44320, United States

  • GSK Investigational Site

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    Springboro, Ohio, 45066, United States

  • GSK Investigational Site

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    Westlake, Ohio, 44145, United States

  • GSK Investigational Site

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    Chattanooga, Tennessee, 37421, United States

  • GSK Investigational Site

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    Arlington, Texas, 76012, United States

  • GSK Investigational Site

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    Austin, Texas, 78704, United States

  • GSK Investigational Site

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    Austin, Texas, 78757, United States

  • GSK Investigational Site

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    Austin, Texas, 78759, United States

  • GSK Investigational Site

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    Bellaire, Texas, 77401, United States

  • GSK Investigational Site

    RECRUITING

    Brownsville, Texas, 78526, United States

  • GSK Investigational Site

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    Dallas, Texas, 75243, United States

  • GSK Investigational Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • GSK Investigational Site

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    Houston, Texas, 77004, United States

  • GSK Investigational Site

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    Irving, Texas, 75061, United States

  • GSK Investigational Site

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    Richmond, Texas, 77406, United States

  • GSK Investigational Site

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    San Antonio, Texas, 78209, United States

  • GSK Investigational Site

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    San Antonio, Texas, 78215, United States

  • GSK Investigational Site

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    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

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    Seabrook, Texas, 77586, United States

  • GSK Investigational Site

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    Sugar Land, Texas, 77479, United States

  • GSK Investigational Site

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    Tomball, Texas, 77375, United States

  • GSK Investigational Site

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    Waco, Texas, 76710, United States

  • GSK Investigational Site

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    Waco, Texas, 76712, United States

  • GSK Investigational Site

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    West Jordan, Utah, 84088, United States

  • GSK Investigational Site

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    Manassas, Virginia, 20110, United States

  • GSK Investigational Site

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    Norfolk, Virginia, 23502, United States

  • GSK Investigational Site

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    Seattle, Washington, 98105, United States

  • GSK Investigational Site

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    Broadmeadow, New South Wales, 2292, Australia

  • GSK Investigational Site

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    Heidelberg, Victoria, 3084, Australia

  • GSK Investigational Site

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    Québec, Quebec, G1N 4V3, Canada

  • GSK Investigational Site

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    Pokfulam, Hong Kong

  • GSK Investigational Site

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    Gifu, 503-8502, Japan

  • GSK Investigational Site

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    Kanagawa, 215-0026, Japan

  • GSK Investigational Site

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    Kyoto, 602-8566, Japan

  • GSK Investigational Site

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    Musashino, 180-8610, Japan

  • GSK Investigational Site

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    Yokohama, 236-0004, Japan

  • GSK Investigational Site

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    Wellington, 6021, New Zealand

  • GSK Investigational Site

    RECRUITING

    San Juan, 00927, Puerto Rico

  • GSK Investigational Site

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    Riyadh, 11472, Saudi Arabia

  • GSK Investigational Site

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    Chiayi City, 600, Taiwan

  • GSK Investigational Site

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • GSK Investigational Site

    RECRUITING

    Kaohsiung City, 83301, Taiwan

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