Efimosfermin alfa for adults with biopsy-confirmed F2 or F3 MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 study enrolls adults aged 18–75 with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and stage F2 or F3 fibrosis. Eligible participants must have a NAS score ≥4 confirmed by a central pathologist and at least two components of metabolic syndrome. Participants will be assigned to receive efimosfermin alfa or placebo and followed for liver-related outcomes and safety. Study procedures include baseline liver biopsy confirmation and regular clinical and laboratory assessments at GSK investigational sites in California.

Why it matters

Who can join: the full rules

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

Where it's running

• GSK Investigational Site
  Chandler, Arizona, United States Recruiting
• GSK Investigational Site
  Tucson, Arizona, United States Recruiting
• GSK Investigational Site
  Little Rock, Arkansas, United States Recruiting
• GSK Investigational Site
  Arcadia, California, United States Recruiting
• GSK Investigational Site
  Covina, California, United States Recruiting
• GSK Investigational Site
  Folsom, California, United States Recruiting

+41 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Additive Physical Activity for Hypothyroidism in Older Women with Glaucoma and Fatty Liver

  We’re testing whether adding a treadmill-based exercise program to standard thyroid treatment helps improve health in older women who have subclinical hypothyroidism, glaucoma, and fatty liver.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07599241

• Lowering insulin to reduce liver fat production

  This study will try a short course of diazoxide to lower insulin and see if it reduces the liver's creation of new fat in adults with obesity, insulin resistance, and MASLD.

  Recruiting Phase 1 Columbia University · New York, New York · NCT07403604

• Efimosfermin alfa for adults with liver impairment

  This trial will test a single dose of efimosfermin alfa in adults with cirrhosis-related hepatic impairment from steatotic liver disease, with and without significant alcohol use, to measure drug levels and safety.

  Recruiting at 5 sites Phase 1 GlaxoSmithKline · Rialto, California and 4 other locations · NCT07358546

• Efimosfermin alfa injections for adults with F2–F3 MASH

  This study tests whether efimosfermin alfa injections are safe and tolerable for adults (18–75) with known or suspected metabolic dysfunction-associated steatohepatitis (MASH) and F2–F3 fibrosis.

  Recruiting at 66 sites Phase 3 GlaxoSmithKline · Arcadia, California and 65 other locations · NCT07221188

• Mediterranean diet with or without aerobic exercise for women with familial Mediterranean fever and fatty liver

  This trial will test whether adding regular aerobic exercise to a Mediterranean diet helps women with familial Mediterranean fever who have non-alcoholic fatty liver disease.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07130318

• Cardiovascular health in children and young adults with chronic conditions

  This project will see if children and young adults (ages 6-25) with chronic health conditions show early signs of aging in large and small blood vessels using noninvasive imaging and clinical tests.

  Recruiting Semmelweis University · Budapest and 2 other locations · NCT07086989

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.