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

April 25, 2024 updated by: 89bio, Inc.

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

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis [NASH]).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1050

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211-3859
        • Recruiting
        • 89bio Clinical Study Site
        • Contact:
          • 89bio Clinical Study Site
    • Florida
      • Ocala, Florida, United States, 34471
        • Recruiting
        • 89bio Clinical Study Site
        • Contact:
          • 89bio Clinical Study Site
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
        • Recruiting
        • 89bio Clinical Study Site
        • Contact:
          • 89bio Clinical Study Site
    • Texas
      • Wichita Falls, Texas, United States, 76301
        • Recruiting
        • 89bio Clinical Study Site
        • Contact:
          • 89bio Clinical Study Site
    • Virginia
      • Richmond, Virginia, United States, 23226-1925
        • Recruiting
        • 89bio Clinical Study Site
        • Contact:
          • 89bio Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF)
  • Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation (qualifying biopsy must be either within 6 months of screening visit [with additional requirements] or obtained during screening period)
  • Body mass index (BMI) at screening ≥25.0 (≥23 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2)

Key Exclusion Criteria:

  • Chronic liver diseases other than MASH/NASH
  • History or 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) must be on stable dose for at least 6 months prior to screening

Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegozafermin Regimen 1
Biological: Pegozafermin
Subcutaneous injection
Other Names:
  • BIO89-100
Experimental: Pegozafermin Regimen 2
Biological: Pegozafermin
Subcutaneous injection
Other Names:
  • BIO89-100
Placebo Comparator: Placebo
Matched Placebo will be administered in Regimens 1 and 2.
Other: Placebo
Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52
Time Frame: Week 52
Worsening of NASH is defined as increase in NAFLD Activity Score (NAS) for ballooning, inflammation, or steatosis
Week 52
Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52
Time Frame: Week 52
Resolution of NASH 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.
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36
Time Frame: Baseline, Week 52
Baseline, Week 52
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
Time Frame: Up to Month 36
Up to Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

89bio, Inc.

Investigators

  • Study Director: Millie Gottwald, PharmD, 89bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO89-100-131

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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