Evaluating efimosfermin for patients with compensated cirrhosis and metabolic dysfunction

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 study aims to assess the safety, tolerability, and preliminary efficacy of efimosfermin in individuals diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) and compensated cirrhosis characterized by stage F4 fibrosis. Participants will receive either efimosfermin or a placebo, and their responses will be monitored to gather pharmacokinetic data. The study focuses on individuals aged 18 to 75 who meet specific metabolic syndrome criteria and have confirmed liver biopsy results. The goal is to determine if efimosfermin can provide therapeutic benefits for this patient population.

Why it matters

Who can join: the full rules

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's running

• GSK Investigational Site
  Chandler, Arizona, United States Recruiting
• GSK Investigational Site
  Mesa, Arizona, United States Recruiting
• GSK Investigational Site
  Tucson, Arizona, United States Recruiting
• GSK Investigational Site
  Fresno, California, United States Recruiting
• GSK Investigational Site
  Lancaster, California, United States Recruiting
• GSK Investigational Site
  Pasadena, California, United States Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Efimosfermin vs. placebo in adults with compensated cirrhosis from MASH

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  Recruiting at 35 sites Phase 3 GlaxoSmithKline · Little Rock, Arkansas and 34 other locations · NCT07704892

• Efimosfermin vs placebo in adults with compensated cirrhosis from MASH

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  Recruiting at 30 sites Phase 3 GlaxoSmithKline · Little Rock, Arkansas and 29 other locations · NCT07701993

• ALN-CIDEB for adults with fibrotic MASH (phase 2)

  This phase 2 study tests ALN-CIDEB versus placebo to see if it can reduce liver fat, injury, and scarring in adults with fibrotic MASH.

  Recruiting at 24 sites Phase 2 Regeneron Pharmaceuticals · Tucson, Arizona and 23 other locations · NCT07631637

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.