Status:
RECRUITING
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Lead Sponsor:
89bio, Inc.
Conditions:
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
1350 Patients enrolled
Trial Details
Trial ID
NCT06318169
Start Date
March 13 2024
End Date
February 1 2029
Last Update
February 11 2026
Active Locations (331)
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1
89bio Clinical Study Site
Birmingham, Alabama, United States, 35209
2
89bio Clinical Study Site
Chandler, Arizona, United States, 85224
3
89bio Clinical Study Site
Flagstaff, Arizona, United States, 86001
4
89bio Clinical Study Site
Glendale, Arizona, United States, 85036