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

Official 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.

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 80 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 1,350 participants

Study Arms

• Pegozafermin Regimen 1 (EXPERIMENTAL)
• Pegozafermin Regimen 2 (EXPERIMENTAL)
• Placebo (PLACEBO_COMPARATOR)
  Matched Placebo will be administered in Regimens 1 and 2.

Interventions

• BIOLOGICAL: Pegozafermin — Subcutaneous injection
• OTHER: Placebo — Subcutaneous injection

Primary Outcomes

• Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52 (Week 52)
• Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52 (Week 52)
• Time to First Occurrence of Disease Progression (Up to 5 years)

Secondary Outcomes

• Percent Change from Baseline in Alanine Aminotransferase at Week 52 (Baseline, Week 52)
• Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52 (Baseline, Week 52)

Eligibility Criteria

Key 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).

Key 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

Other inclusion and exclusion criteria may apply.

Trial Locations

• 89bio Clinical Study Site, Birmingham, Alabama, United States
• 89bio Clinical Study Site, Chandler, Arizona, United States
• 89bio Clinical Study Site, Flagstaff, Arizona, United States
• 89bio Clinical Study Site, Glendale, Arizona, United States
• 89bio Clinical Study Site, Tucson, Arizona, United States
• 89bio Clinical Study Site, Conway, Arkansas, United States
• 89bio Clinical Study Site, Little Rock, Arkansas, United States
• 89bio Clinical Study Site, North Little Rock, Arkansas, United States
• 89bio Clinical Study Site, Canoga Park, California, United States
• 89bio Clinical Study Site, Coronado, California, United States
• ...and 10 more locations

Contact Information

• ENLIGHTEN clinical trial — CONTACT
  Phone: 1-415-432-9270
  Email: enlighten@89bio.com

Study Officials

• Millie Gottwald, PharmD — STUDY_DIRECTOR
  89bio, Inc.

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

View all Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis clinical trials