Phase 3Recruiting
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
- Sponsor
- 89bio, Inc. (Industry)
- Enrolment
- 762 planned
- Conditions
- Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
- Interventions
- Pegozafermin; Placebo
- Ages
- adults, older adults
- Registry
- NCT06419374
Full record on ClinicalTrials.gov
From the registry
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 \[previously known as nonalcoholic steatohepatitis, NASH\]).
Primary outcomes
- Proportion of Participants Achieving Fibrosis Regression
- Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered