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BIO89-100-132 The ENLIGHTEN-Cirrhosis Study

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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]).

Details

Full study title BIO89-100-132 A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Protocol number OCR46010
ClinicalTrials.gov ID NCT06419374
Phase Phase 3

Eligibility

Key Inclusion Criteria:

  • Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).

  • At least 1 metabolic risk factor.

  • Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis [NASH] Clinical Research Network (CRN) system) with compensated cirrhosis.

  • Body mass index (BMI) at screening 鈮�25.0 (鈮�23.0 for Asian participants) and 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.

Lead researcher

  • Ginger Clark, MD, MS
    Gastroenterologist, Transplant Hepatologist

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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