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Evaluating Pegozafermin for Liver Fibrosis in MASH Patients

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Phase 3 Interventional 89bio, Inc. · NCT06318169

This study is testing if a new medication called pegozafermin can help adults with liver fibrosis caused by metabolic dysfunction-associated steatotic liver disease feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1350 (estimated)
Ages18 Years to 80 Years
SexAll
Sponsor89bio, Inc. Industry-sponsored
Locations342 sites (Birmingham, Alabama and 341 other locations)
Trial IDNCT06318169 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of two different doses of pegozafermin in adults diagnosed with metabolic dysfunction-associated steatotic liver disease (MASH) and fibrosis stages 2 or 3. Participants will be assessed for their liver condition through biopsy confirmation and will receive either the medication or a placebo. The goal is to determine how well pegozafermin can improve liver fibrosis in this patient population.

Who should consider this trial

Good fit: Ideal candidates are males or non-pregnant females aged 18 to 80 with biopsy-confirmed MASH and fibrosis stages 2 or 3.

Not a fit: Patients with chronic liver diseases other than MASH/NASH or evidence of cirrhosis will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and outcomes for patients suffering from MASH with fibrosis.

How similar studies have performed: Other studies have shown promise in treating liver fibrosis with similar approaches, but the specific use of pegozafermin is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
* Biopsy-confirmed MASH with fibrosis stage F2 or F3
* Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).

Key Exclusion Criteria:

* Chronic liver diseases other than MASH
* Evidence of cirrhosis on screening liver biopsy
* Have type 1 diabetes or poorly controlled type 2 diabetes
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
* Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Other inclusion and exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 341 other locations

+292 more sites — see ClinicalTrials.gov for the full list.

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 Steatotic Liver Disease / Nonalcoholic Steatohepatitis With FibrosisLiver DiseasesFatty LiverDigestive System DiseasesMetabolic diseasesMetabolic Dysfunction-Associated SteatohepatitisMASHSteatohepatitis
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.