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Efimosfermin Alfa for MASH with F2 or F3 Fibrosis

This study is looking into the safety of Efimosfermin Alfa for people with known or suspected MASH (Metabolic Dysfunction-Associated Steatohepatitis), a type of fatty liver disease, with moderate to severe scarring (fibrosis, stages F2 or F3). You might receive Efimosfermin Alfa or a placebo (an inactive substance). Researchers will track any side effects and serious lab changes over 52 weeks to understand how well Efimosfermin Alfa is tolerated. The study plans to enroll about 1250 participants aged 18 to 75 who also have metabolic syndrome. The current recruitment status is unclear.

Study design
This is an interventional study comparing Efimosfermin Alfa to a placebo. It aims to enroll about 1250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety outcomes for 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221188

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

Recruiting
PHASE3Ages 18–75InterventionalTreatment
GlaxoSmithKline
~1,250 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:Efimosfermin AlfaPlacebo

At a glance

Recruiting sites
66 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Measured over At Week 52
+2 more outcomes measured

Conditions

Non-alcoholic Fatty Liver Disease

Explore related trials

Nonalcoholic Steatohepatitis

NCT07221188

Where you'd take part

This study runs at 66 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • GSK Investigational Site

    Arcadia, Californiastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Covina, Californiastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    San Diego, Californiastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Santa Maria, Californiastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Van Nuys, Californiastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Boynton Beach, Floridastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Cape Coral, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severityAt Week 52
  • Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severityAt Week 52
  • Number of participants with Grade 3 and Grade 4 laboratory abnormalitiesAt Week 52