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)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Metabolic Dysfunction-associated Steatohepatitis
In brief
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.
Key facts
- Study ID
- NCT07704892
- Run by
- GlaxoSmithKline
- People needed
- 380
- Starts
- 2026-07-22
- Expected to finish
- 2033-12-08
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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 is running
- GSK Investigational Site — Miami, Florida, United States (enrolling)
- GSK Investigational Site — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.