Evaluating Pegozafermin for Liver Fibrosis in MASH Patients

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 89bio Clinical Study Site
  Birmingham, Alabama, United States Recruiting
• 89bio Clinical Study Site
  Chandler, Arizona, United States Recruiting
• 89bio Clinical Study Site
  Glendale, Arizona, United States Recruiting
• 89bio Clinical Study Site
  Sun City, Arizona, United States Recruiting
• 89bio Clinical Study Site
  Tucson, Arizona, United States Recruiting
• 89bio Clinical Study Site
  Tucson, Arizona, United States Recruiting

+320 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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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.