Status:
RECRUITING
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Lead Sponsor:
GlaxoSmithKline
Conditions:
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in indivi...
Eligibility Criteria
Inclusion
- Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
- Age \>=18 and \<=75 years at enrollment
- History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition:
- Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist
Exclusion
- Contraindication or ineligibility for percutaneous liver biopsy
- 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)
- Glycated hemoglobin \>=9.0%
- Model for End-Stage Liver Disease score \>=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)
- Phosphatidyl ethanol (PEth) \>=80 ng/mL at Screening
- Known co-infection with any of the following:
- Human immunodeficiency virus;
- Hepatitis B virus;
- Hepatitis C virus (HCV);
- Hepatitis D virus; or
- 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 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.
- Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2031
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT07221227
Start Date
October 23 2025
End Date
December 12 2031
Last Update
October 31 2025
Active Locations (1)
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1
GSK Investigational Site
Miami, Florida, United States, 33156