A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
Sponsor89bio, Inc.
About this trial
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
Qualifiers
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 (m²) (≥23 kg/m² for Asian participants).
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Pegozafermin
- Placebo
Treatment groups
1,350 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov