A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Recruiting now Phase 3 NCT06318169
Run by 89bio, Inc. · for 18 to 80 · All sexes
What this study is about
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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).
🚫 You may not be able to join if…
- 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
- 89bio Clinical Study Site, Birmingham, Alabama, United States
- 89bio Clinical Study Site, Chandler, Arizona, United States
- 89bio Clinical Study Site, Flagstaff, Arizona, United States
- 89bio Clinical Study Site, Glendale, Arizona, United States
- 89bio Clinical Study Site, Sun City, Arizona, United States
- 89bio Clinical Study Site, Tucson, Arizona, United States
- 89bio Clinical Study Site, Conway, Arkansas, United States
- 89bio Clinical Study Site, Little Rock, Arkansas, United States
- 89bio Clinical Study Site, North Little Rock, Arkansas, United States
- 89bio Clinical Study Site, Canoga Park, California, United States
- 89bio Clinical Study Site, Coronado, California, United States
- 89bio Clinical Study Site, Escondido, California, United States
+ 349 more sites.
Who to contact
ENLIGHTEN clinical trial · 1-415-432-9270 · enlighten@89bio.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06318169.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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