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 now · Phase 3 · Has a placebo group

Conditions studied: Non-alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT07221188

Run by

GlaxoSmithKline

People needed

1250

Starts

2025-12-12

Expected to finish

2028-03-24

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Covina, California, United States (enrolling)
• GSK Investigational Site — Los Angeles, California, United States (enrolling)
• GSK Investigational Site — San Diego, California, United States (enrolling)
• GSK Investigational Site — Santa Maria, California, United States (enrolling)
• GSK Investigational Site — Van Nuys, California, United States (enrolling)
• GSK Investigational Site — Boynton Beach, Florida, United States (enrolling)
• GSK Investigational Site — Cape Coral, Florida, United States (enrolling)
• GSK Investigational Site — Doral, Florida, United States (enrolling)
• GSK Investigational Site — Hialeah, Florida, United States (enrolling)
• GSK Investigational Site — Homestead, Florida, United States (enrolling)
• GSK Investigational Site — Inverness, Florida, United States (enrolling)
• GSK Investigational Site — Jacksonville, Florida, United States (enrolling)
• GSK Investigational Site — Kissimmee, Florida, United States (enrolling)
• GSK Investigational Site — Lakeland, Florida, United States (enrolling)
• GSK Investigational Site — Maitland, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami Lakes, Florida, United States (enrolling)
• GSK Investigational Site — Ocala, Florida, United States (enrolling)
• GSK Investigational Site — Palmetto Bay, Florida, United States (enrolling)
• GSK Investigational Site — Sarasota, Florida, United States (enrolling)
• GSK Investigational Site — Arcadia, California, United States (enrolling)

Full record on ClinicalTrials.gov

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