A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Recruiting · NCT06920043 · Interventional (participants receive a specific treatment) · Lead sponsor: GlaxoSmithKline
View the official record on ClinicalTrials.gov →Interventions studied
EfimosferminPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
30 locations listed across 10 US states.
- GSK Investigational Site - Chandler, Arizona, United States
- GSK Investigational Site - Mesa, Arizona, United States
- GSK Investigational Site - Tucson, Arizona, United States
- GSK Investigational Site - Fresno, California, United States
- GSK Investigational Site - Lancaster, California, United States
- GSK Investigational Site - Pasadena, California, United States
- GSK Investigational Site - Rialto, California, United States
- GSK Investigational Site - Santa Maria, California, United States
- GSK Investigational Site - Miami, Florida, United States
- GSK Investigational Site - Viera, Florida, United States
- GSK Investigational Site - Marietta, Georgia, United States
- GSK Investigational Site - Baltimore, Maryland, United States
- GSK Investigational Site - Kansas City, Missouri, United States
- GSK Investigational Site - New York, New York, United States
- GSK Investigational Site - Fayetteville, North Carolina, United States
- GSK Investigational Site - Wilson, North Carolina, United States
- GSK Investigational Site - Austin, Texas, United States
- GSK Investigational Site - Austin, Texas, United States
- GSK Investigational Site - Austin, Texas, United States
- GSK Investigational Site - Dallas, Texas, United States
- GSK Investigational Site - Georgetown, Texas, United States
- GSK Investigational Site - Houston, Texas, United States
- GSK Investigational Site - Houston, Texas, United States
- GSK Investigational Site - Houston, Texas, United States
- GSK Investigational Site - Pasadena, Texas, United States
- GSK Investigational Site - Pearland, Texas, United States
- GSK Investigational Site - San Antonio, Texas, United States
- GSK Investigational Site - San Antonio, Texas, United States
- GSK Investigational Site - Waco, Texas, United States
- GSK Investigational Site - Richmond, Virginia, United States