A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Recruiting now Phase 3 NCT06419374
Run by 89bio, Inc. · for 18 to 75 · All sexes
What this study is about
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
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 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).
🚫 You may not be able to join if…
- 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
- 89bio Clinical Study Site, Birmingham, Alabama, United States
- 89bio Clinical Study Site, Homewood, Alabama, United States
- 89bio Clinical Study Site, Chandler, Arizona, United States
- 89bio Clinical Study Site, Flagstaff, Arizona, United States
- 89bio Clinical Study Site, Peoria, Arizona, United States
- 89bio Clinical Study Site, Phoenix, Arizona, United States
- 89bio Clinical Study Site, Sun City, Arizona, United States
- 89bio Clinical Study Site, Tucson, Arizona, United States
- 89bio Clinical Study Site, Tucson, Arizona, United States
- 89bio Clinical Study Site, Tucson, Arizona, United States
- 89bio Clinical Study Site, Little Rock, Arkansas, United States
- 89bio Clinical Study Site, North Little Rock, Arkansas, United States
+ 305 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: NCT06419374.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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