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)

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

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 75 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 762 participants

Study Arms

• Pegozafermin (EXPERIMENTAL)
• Placebo (PLACEBO_COMPARATOR)
  Matched placebo

Interventions

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

Primary Outcomes

• Proportion of Participants Achieving Fibrosis Regression (Baseline through Month 24)
• Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events (Baseline up to 5 years)

Secondary Outcomes

• Change from Baseline in Enhanced Liver Fibrosis (ELF) Score (Baseline, up to Month 60)
• Change from Baseline in Alanine Aminotransferase (ALT) Level (Baseline, up to Month 60)
• Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE) (Baseline, up to Month 60)
• Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH) (Baseline up to Month 60)

Eligibility Criteria

Key Inclusion Criteria:

* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).

Key Exclusion Criteria:

* Liver disorder other than MASH.
* History or evidence of hepatic decompensation.
* History or evidence of hepatocellular carcinoma.
* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
* Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.

Other protocol-defined inclusion and exclusion criteria may apply.

Trial Locations

• 89bio Clinical Study Site, Birmingham, Alabama, United States
• 89bio Clinical Study Site, Homewood, Alabama, United States
• 89bio Clinical Study Site, Chandler, Arizona, United States
• 89bio Clinical Study Site, Flagstaff, Arizona, United States
• 89bio Clinical Study Site, Peoria, Arizona, United States
• 89bio Clinical Study Site, Phoenix, Arizona, United States
• 89bio Clinical Study Site, Tucson, Arizona, United States
• 89bio Clinical Study Site, Tucson, Arizona, United States
• 89bio Clinical Study Site, Tucson, Arizona, United States
• 89bio Clinical Study Site, Little Rock, Arkansas, United States
• ...and 10 more locations

Contact Information

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

Study Officials

• Maya Margalit, MD — STUDY_DIRECTOR
  89bio, Inc.

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