NCT06419374

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 762 (estimated)
• Sponsor: 89bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 \[previously known as nonalcoholic steatohepatitis, NASH\]).

Conditions

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	Pegozafermin	Subcutaneous injection
DRUG	Placebo	Subcutaneous injection

Timeline

• Start date: 2024-05-24
• Primary completion: 2028-06-01
• Completion: 2031-08-01
• First posted: 2024-05-17
• Last updated: 2026-04-03

Locations

291 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study