A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

Last updated: April 13, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disease

Treatment

Efimosfermin Alfa

Placebo

Clinical Study ID

NCT07221188
306246
2025-523674-16
  • Ages 18-75
  • All Genders

Study Summary

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able and willing to understand and sign a written informed consent form (ICF) thatmust 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 perAmerican Heart Association definition

  • History or presence of known or suspected MASH with evidence of fibrosis

Exclusion

Exclusion Criteria:

  • ALT or AST >=5 × upper limit of normal (ULN)

  • Total bilirubin (BILI) >=1.3 milligram per deciliter (mg/dL). Individuals withdocumented Gilbert's syndrome may be enrolled if they experienced an isolatedincrease 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 beenrolled 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 aPLT count between 110,000/mm^3 and 140,000/mm^3 may be enrolled after discussionwith 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 Collaborationequation.

  • 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 elevatedin 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. HepatitisE virus.

  • Chronic liver disease from any other cause including, but not limited to, alcoholicliver disease; evidence of portal hypertension; viral hepatitis, or any history orevidence of cirrhosis; or decompensated liver disease such as clinical ascites,bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathyprior to Screening or Day 1.

  • Current or history of excessive alcohol intake for >=3 months within the 12-monthperiod prior to Screening

Study Design

Total Participants: 1250
Treatment Group(s): 2
Primary Treatment: Efimosfermin Alfa
Phase: 3
Study Start date:
December 12, 2025
Estimated Completion Date:
March 24, 2028

Connect with a study center

  • GSK Investigational Site

    Arcadia, California 91006
    United States

    Active - Recruiting

  • GSK Investigational Site

    Covina, California 91723
    United States

    Active - Recruiting

  • GSK Investigational Site

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • GSK Investigational Site

    Santa Maria, California 93458
    United States

    Active - Recruiting

  • GSK Investigational Site

    Cape Coral, Florida 33914
    United States

    Active - Recruiting

  • GSK Investigational Site

    Doral, Florida 33016
    United States

    Active - Recruiting

  • GSK Investigational Site

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • GSK Investigational Site

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • GSK Investigational Site

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • GSK Investigational Site

    Kissimmee, Florida 34744
    United States

    Active - Recruiting

  • GSK Investigational Site

    Lakeland, Florida 33803
    United States

    Active - Recruiting

  • GSK Investigational Site

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami, Florida 33155
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • GSK Investigational Site

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • GSK Investigational Site

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami 4164138, Florida 4155751 33135
    United States

    Site Not Available

  • GSK Investigational Site

    Ocala 4166673, Florida 4155751 34471
    United States

    Site Not Available

  • GSK Investigational Site

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • GSK Investigational Site

    Springfield, Missouri 62703
    United States

    Active - Recruiting

  • GSK Investigational Site

    St Louis, Missouri 63141
    United States

    Active - Recruiting

  • GSK Investigational Site

    St Louis 4407066, Missouri 4398678 63141
    United States

    Site Not Available

  • GSK Investigational Site

    Jersey City, New Jersey 07059
    United States

    Active - Recruiting

  • GSK Investigational Site

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • GSK Investigational Site

    New York, New York 10036
    United States

    Active - Recruiting

  • GSK Investigational Site

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • GSK Investigational Site

    Akron, Ohio 44320
    United States

    Active - Recruiting

  • GSK Investigational Site

    Springboro, Ohio 45066
    United States

    Active - Recruiting

  • GSK Investigational Site

    Austin, Texas 78745
    United States

    Active - Recruiting

  • GSK Investigational Site

    Brownsville, Texas 78526
    United States

    Active - Recruiting

  • GSK Investigational Site

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • GSK Investigational Site

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • GSK Investigational Site

    Richmond, Texas 77406
    United States

    Active - Recruiting

  • GSK Investigational Site

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • GSK Investigational Site

    Seabrook, Texas 77586
    United States

    Active - Recruiting

  • GSK Investigational Site

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • GSK Investigational Site

    Waco, Texas 76710
    United States

    Active - Recruiting

  • GSK Investigational Site

    San Antonio 4726206, Texas 4736286 78215
    United States

    Site Not Available

  • GSK Investigational Site

    Waco 4739526, Texas 4736286 76712
    United States

    Site Not Available

  • GSK Investigational Site

    West Jordan, Utah 84088
    United States

    Active - Recruiting

  • GSK Investigational Site

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • GSK Investigational Site

    Seattle, Washington 98105
    United States

    Active - Recruiting

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