Efimosfermin vs. placebo in adults with compensated cirrhosis from MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized phase 3 trial in adults with compensated cirrhosis from MASH. The study has two parts: Part A compares Efimosfermin to placebo, and Part B is an open-label extension for eligible participants who complete Part A. Participants are assigned to receive either Efimosfermin alfa or placebo, with safety and efficacy assessed over the study period. Eligible participants are adults 18–75 with metabolic syndrome components and biopsy-confirmed cirrhosis, while those with other liver diseases, decompensation, or certain diabetes or pancreatic conditions are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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 running

• GSK Investigational Site
  Little Rock, Arkansas, United States Recruiting
• GSK Investigational Site
  Arcadia, California, United States Recruiting
• GSK Investigational Site
  Arroyo Grande, California, United States Recruiting
• GSK Investigational Site
  Folsom, California, United States Recruiting
• GSK Investigational Site
  Van Nuys, California, United States Recruiting
• GSK Investigational Site
  Cape Coral, Florida, United States Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.