Skip To Main Content

Search

For optimal search results, please limit to 2 product keywords

If you are searching for information related to a product:

  • For optimal results, please enter at least 2 search terms in addition to product name
  • Example: [product name] [search term] [search term]
  • Example: Product + clinical trials
  • For an exact match, please include search terms in double quotations. For example: "Elevatum"

    Please enter search terms.

    Phase III: Pegozafermin in Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis (ENLIGHTEN-Fibrosis)

    Clinical Trial Overview

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

    Objective

    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

    MASH: metabolic dysfunction-associated steatohepatitis
    FGF21: fibroblast growth factor 21

    Primary Endpoints

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

    Secondary Endpoints

    • Percent Change from Baseline in Alanine Aminotransferase at Week 52 [Time Frame: Baseline, Week 52]
    • Absolute Change From Baseline in Enhanced Liver Fibrosis Score at Week 52 [Time Frame: Baseline, Week 52]

    NAFLD: non-alcoholic fatty liver disease
    NAS: NAFLD Activity Score

    Pegozafermin

    Modality: FGF21 (fibroblast growth factor 21) Analog

    View Details
    View Related Trials

    QUICK LINKS

    Molecule
    Clinical Trial Overview
    Inclusion and Exclusion Criteria
    Enrollment and Resources
    Contact an MSL
    View on ClinicalTrials.gov

    Inclusion and Exclusion Criteria

    Key Inclusion Criteria Key Exclusion Criteria
    • Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form
    • Biopsy-confirmed MASH with fibrosis stage F2 or F3
    • Body mass index at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants).
    • 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 or aspartate aminotransferase ≥250 units per liter
    • Participants taking vitamin E (>400 international units/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

    MASH: metabolic dysfunction-associated steatohepatitis

    Enrollment & Resources

    Enrollment

    For more information on eligibility criteria, view the study or reach out to our team.

    General icon

    Web

    ClinicalTrials.gov
    Identifier: NCT06318169

    Visit Site
    Call icon

    Phone

    1-888-662-6728
    (US and Canada)

    Call Us
    Email icon

    Email

    [email protected]

    Email Us

    Clinical Trial Site Locations

    Clinical Trial Site Locations

    For more information on recruitment status, or where the study is being conducted

    Visit ClinicalTrials.gov

    Information is consistent with ClinicalTrials.gov as of December 17, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

    Looking for more information?

    Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.

    Connect with an MSL
    Submit a Request

    Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT

    TOP

    • MASH
      metabolic dysfunction-associated steatohepatitis

    • FGF21
      fibroblast growth factor 21

    • NAFLD
      non-alcoholic fatty liver disease

    • NAS
      NAFLD Activity Score