NCT06318169

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,350 (estimated)
• Sponsor: 89bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	Pegozafermin	Subcutaneous injection
OTHER	Placebo	Subcutaneous injection

Timeline

• Start date: 2024-03-13
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2024-03-19
• Last updated: 2026-02-11

Locations

331 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Georgia, Germany, Hong Kong, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study