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 Phase 3 trial evaluates the safety and efficacy of efimosfermin alpha in adults with compensated cirrhosis due to MASH. Participants will be randomly assigned to receive either efimosfermin or placebo and will be monitored for liver-related outcomes and overall safety. Eligible participants are aged 18–75 with compensated cirrhosis confirmed by non-invasive means and metabolic syndrome features. Exclusion criteria include other chronic liver diseases, decompensated liver disease, liver cancer history, certain diabetes histories, recent pancreatic issues, recent major weight-loss procedures, very high liver enzymes, and excessive alcohol use. The study is led by GlaxoSmithKline with investigational sites in Little Rock and two locations in California.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants aged between 18 and 75 years at enrollment.
* Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.
* Participants with history or presence of at least two components of metabolic syndrome.

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 complications.
* Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.
* Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.
* Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5 times upper limit normal (ULN).
* Participants with current or history of excessive alcohol intake.

Where it's running

• GSK Investigational Site
  Little Rock, Arkansas, United States Recruiting
• GSK Investigational Site
  Folsom, California, United States Recruiting
• GSK Investigational Site
  Santa Maria, California, United States Recruiting
• GSK Investigational Site
  Cape Coral, Florida, United States Recruiting
• GSK Investigational Site
  Fort Myers, Florida, United States Recruiting
• GSK Investigational Site
  Hialeah, 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.