Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis MASH
Led by GlaxoSmithKline · Updated on 2026-04-16
1200
Participants Needed
49
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of efimosfermin alfa in people with metabolic dysfunction-associated steatohepatitis MASH who have biopsy-confirmed liver fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare efimosfermin alfa to placebo in improving liver-related outcomes and resolving steatohepatitis over a long-term period. Participants will be randomly assigned to one of three groups two different dose levels of efimosfermin alfa or a placebo group. The study treatment will be administered under medical supervision, and the trial includes multiple assessments at baseline, Week 52, and Month 48. The study will measure liver fibrosis improvement, steatohepatitis resolution, and liver-related clinical outcomes, among other key health indicators. During the study, participants will undergo liver biopsies, blood tests, imaging scans, and questionnaires to monitor liver health and treatment effects. Researchers will track clinical outcomes for up to 48 months from the start of treatment. Safety will be closely monitored through adverse event reporting and laboratory tests. Participants are expected to attend regular visits for evaluations and follow-up throughout the study duration.
CONDITIONS
Brief Title
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give written informed consent before starting study procedures
- Age 18 to 75 years at enrollment
- History or presence of two or more metabolic syndrome components as defined by the American Heart Association
- Liver biopsy confirming MASH with stage F2 or F3 fibrosis and a NAS score of 4 or higher as confirmed by a central pathologist
You will not qualify if you...
- Contraindication or inability to undergo percutaneous liver biopsy
- ALT or AST levels 5 times or more above the upper limit of normal
- Total bilirubin 1.3 mg/dL or higher except for Gilbert's syndrome with specific criteria
- Serum albumin 3.5 g/dL or less
- INR 1.3 or higher not due to anticoagulation therapy, with some exceptions
- Alkaline phosphatase 2 times or more above the upper limit of normal
- Platelet count below 140,000/mm3, with possible exceptions after medical discussion
- Serum creatinine 1.5 mg/dL or higher or creatinine clearance 60 mL/min/1.73 m2 or less
- Alpha-fetoprotein 20 ng/mL or higher
- Glycated hemoglobin 9.0% or higher
- Model for End-Stage Liver Disease score 12 or higher unless elevated due to non-liver dysfunction
- Phosphatidyl ethanol 80 ng/mL or higher at screening
- Infection with HIV, hepatitis B, or hepatitis C
- Chronic liver disease from other causes including alcoholic liver disease, cirrhosis, portal hypertension, or decompensated liver disease
- Current or recent history of excessive alcohol use within 12 months prior to screening
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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