RecruitingMetabolic Dysfunction-associated Steatohepatitis
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Eligible age
18–75 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.
Sponsor: GlaxoSmithKline
You may qualify if…
- ✓ Participants aged between 18 and 75 years at enrolment.
- ✓ Participants with history or presence of at least two components of metabolic syndrome.
- ✓ Liver biopsy consistent with cirrhosis (fibrosis stage 4).
You may not qualify if…
- ✕ Participants with other chronic liver diseases.
- ✕ Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
- ✕ Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications.
- ✕ History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.
- ✕ A recent history or planned surgical procedures or medications intended to produce significant weight loss.
- ✕ Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>= 5 times upper limit normal (ULN).
- ✕ Current or history of excessive alcohol intake
Where it's recruiting
Source: ClinicalTrials.gov · NCT07704892 · last updated 2026-09-18