Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Tolerability of Efimosfermin Alfa in Adults With F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis ZENITH-2
Led by GlaxoSmithKline · Updated on 2026-04-16
1250
Participants Needed
43
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis MASH with liver fibrosis at stages F2 or F3. This phase 3, randomized, double-blind, placebo-controlled study aims to better understand how this drug affects participants with this liver condition related to metabolic syndrome components. Participants will be randomly assigned to one of three groups one receiving Efimosfermin Alfa at dose level 1, another receiving Efimosfermin Alfa at dose level 2, and a third group receiving a placebo. The study will monitor the effects of these treatments over a period of 52 weeks, assessing safety and tolerability as well as changes in liver fibrosis markers and other related health measures. During the trial, participants will undergo regular assessments including laboratory tests, imaging scans such as MRI and elastography to measure liver stiffness and fat content, and blood tests to monitor liver enzymes and metabolic markers. Researchers will track treatment-emergent adverse events and laboratory abnormalities. The study involves continuous monitoring up to week 52 to evaluate changes from baseline and to ensure participant safety throughout the trial.
CONDITIONS
Brief Title
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to understand and sign a written informed consent form prior to study procedures
- Age 18 through 75 years at enrollment
- History or presence of two or more components of metabolic syndrome as defined by the American Heart Association
- History or presence of known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with evidence of fibrosis
You will not qualify if you...
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels 5 times or more above the upper limit of normal
- Total bilirubin (BILI) 1.3 mg/dL or higher, except for isolated increases due to Gilbert's syndrome
- Serum albumin 3.5 grams per deciliter or less
- International normalized ratio (INR) 1.3 or higher not due to anticoagulation therapy
- Alkaline phosphatase (ALP) 2 times or more above the upper limit of normal
- Platelet count less than 140,000/mm3, with possible exceptions after medical review
- Serum creatinine 1.5 mg/dL or higher or creatinine clearance 60 mL/min/1.73 m2 or less
- Alpha-fetoprotein 20 nanograms per milliliter or higher
- Hemoglobin A1c (HbA1c) 9.0% or higher
- Model for End-Stage Liver Disease (MELD) score 12 or higher unless due to non-liver dysfunction
- Phosphatidylethanol (PEth) 80 ng/mL or higher at screening
- Known co-infection with HIV, hepatitis B, C, D, or E viruses
- Chronic liver disease from other causes including alcoholic liver disease, portal hypertension, viral hepatitis, cirrhosis, or decompensated liver disease
- Current or recent excessive alcohol intake for 3 months or more within the past year
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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