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Evaluating efimosfermin for patients with compensated cirrhosis and metabolic dysfunction

A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

Phase 2 Interventional Boston Pharmaceuticals · NCT06920043

This study is testing if a new treatment called efimosfermin can help people with compensated cirrhosis and metabolic dysfunction feel better and improve their liver health.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment42 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBoston Pharmaceuticals Industry-sponsored
Locations35 sites (Chandler, Arizona and 34 other locations)
Trial IDNCT06920043 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with biopsy-confirmed MASH and stage F4 fibrosis.

Not a fit: Patients with chronic liver disease from other causes or those with decompensated liver disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve liver health and overall outcomes for patients with compensated cirrhosis due to metabolic dysfunction.

How similar studies have performed: While this approach is focused on a specific patient population, similar studies targeting metabolic dysfunction and liver health have shown promise, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metabolic Dysfunction-Associated SteatohepatitisFibroblast growth factorStage 4 fibrosisCompensated Cirrhosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.