A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
In brief
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
Key facts
- Study ID
- NCT06920043
- Run by
- GlaxoSmithKline
- People needed
- 42
- Starts
- 2025-04-09
- Expected to finish
- 2028-07-10
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to understand and sign a written informed consent form (ICF)
- Age 18 through 75 years at enrollment
- History or presence of 2 or more of the 5 components of metabolic syndrome
- Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
- Other inclusion criteria may apply.
You may not qualify if…
- Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
- History of type 1 diabetes
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
- Other exclusion criteria may apply.
Where it is running
- GSK Investigational Site — Chandler, Arizona, United States (enrolling)
- GSK Investigational Site — Mesa, Arizona, United States (enrolling)
- GSK Investigational Site — Tucson, Arizona, United States (enrolling)
- GSK Investigational Site — Fresno, California, United States (enrolling)
- GSK Investigational Site — Lancaster, California, United States (enrolling)
- GSK Investigational Site — Pasadena, California, United States (enrolling)
- GSK Investigational Site — Rialto, California, United States (enrolling)
- GSK Investigational Site — Santa Maria, California, United States (enrolling)
- GSK Investigational Site — Miami, Florida, United States (enrolling)
- GSK Investigational Site — Viera, Florida, United States (enrolling)
- GSK Investigational Site — Marietta, Georgia, United States (enrolling)
- GSK Investigational Site — Baltimore, Maryland, United States (enrolling)
- GSK Investigational Site — Kansas City, Missouri, United States (enrolling)
- GSK Investigational Site — New York, New York, United States (enrolling)
- GSK Investigational Site — Fayetteville, North Carolina, United States (enrolling)
- GSK Investigational Site — Wilson, North Carolina, United States (enrolling)
- GSK Investigational Site — Austin, Texas, United States (enrolling)
- GSK Investigational Site — Austin, Texas, United States (enrolling)
- GSK Investigational Site — Austin, Texas, United States (enrolling)
- GSK Investigational Site — Dallas, Texas, United States (enrolling)
- GSK Investigational Site — Georgetown, Texas, United States (enrolling)
- GSK Investigational Site — Houston, Texas, United States (enrolling)
- GSK Investigational Site — Houston, Texas, United States (enrolling)
- GSK Investigational Site — Houston, Texas, United States (enrolling)
- GSK Investigational Site — Pasadena, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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