A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011250018

Enrollment

Registered

2025-06-26

Start date

2025-08-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH)

Interventions

- Pegozafermin Regimen 1 - Pegozafermin Regimen 2 - Placebo (Matched Placebo will be administered in Regimens 1 and 2)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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)

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
- Number of Participants With at Least an Improvement of Fibrosis >=1 Stage Without Worsening of Steatohepatitis at Week 52 Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis [Time Frame: Week 52] - Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52 Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by >=1 stage. [Time Frame: Week 52] - Time to First Occurrence of Disease Progression Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events [Time Frame: Up to 5 years]	—

Measure

Time frame

- Number of Participants With at Least an Improvement of Fibrosis >=1 Stage Without Worsening of Steatohepatitis at Week 52 Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis [Time Frame: Week 52] - Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52 Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by >=1 stage. [Time Frame: Week 52] - Time to First Occurrence of Disease Progression Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events [Time Frame: Up to 5 years]

—

Countries

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, France, Georgia, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactRyuichi Nagao

Medpace Japan K.K.

RSJapan1@medpace.com+81-3-4563-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026