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Evaluating Pegozafermin for Liver Disease in Patients with Compensated Cirrhosis

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

Phase 3 Interventional 89bio, Inc. · NCT06419374

This study is testing if a new treatment called pegozafermin can improve liver health in people with compensated cirrhosis caused by metabolic issues.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment762 (estimated)
Ages18 Years to 75 Years
SexAll
Sponsor89bio, Inc. Industry-sponsored
Locations296 sites (Birmingham, Alabama and 295 other locations)
Trial IDNCT06419374 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of pegozafermin in participants diagnosed with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). Participants must have biopsy-confirmed fibrosis stage F4 MASH and at least one metabolic risk factor. The study involves administering either pegozafermin or a placebo to assess its impact on liver health. The trial aims to provide insights into potential new treatments for this serious liver condition.

Who should consider this trial

Good fit: Ideal candidates are males or non-pregnant females aged 18 to 75 with biopsy-confirmed F4 MASH and at least one metabolic risk factor.

Not a fit: Patients with liver disorders other than MASH or those with a history of hepatic decompensation or hepatocellular carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and quality of life for patients with compensated cirrhosis due to MASH.

How similar studies have performed: While this approach is focused on a specific patient population, similar studies targeting liver diseases have shown promising results, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).

Key Exclusion Criteria:

* Liver disorder other than MASH.
* History or evidence of hepatic decompensation.
* History or evidence of hepatocellular carcinoma.
* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
* Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.

Other protocol-defined inclusion and exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 295 other locations

+246 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 Steatohepatitis / Nonalcoholic Steatohepatitis With Compensated CirrhosisLiver diseaseFatty LiverDigestive System DiseasesMetabolic diseasesMetabolic Dysfunction-Associated SteatohepatitisMASHNonalcoholic steatohepatitis
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.