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    Digestive Health Clinical Trials

    A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/​Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

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    What is the purpose of this study?

    This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

    Eligibility

    • Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.

    • Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.

    • Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

      • Steatosis (scored 0 to 3),
      • Ballooning degeneration (scored 0 to 2), and
      • Lobular inflammation (scored 0 to 3).

    • Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS <4 may be enrolled and are not required to meet 1 point in each of the components of NAS.

    Where can I participate?

    Hoag Hospital Newport Beach
    1 Hoag
    Newport Beach, CA 92663


    Vianh Truong

    vianh.truong@hoag.org


    More about this Clinical Trial

    What is the full name of this Clinical Trial?

    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

    • Disease Type/ConditionNASH With Fibrosis, MASH With Fibrosis
    • Principal InvestigatorBrian T. Lee, MD
    • Co-InvestigatorsTse-Ling Fong, MD
    • Age GroupAdult, Older Adult
    • PhaseIII
    • ClinicalTrials.gov IDNCT06215716

    Hoag Digestive Health Institute

    Hoag Digestive Health Institute provides advanced, comprehensive care for the full spectrum of digestive conditions, with access to world-class specialists, diagnostics and imaging, advanced interventional therapeutics, and clinical trials. Patients benefit from a research-driven approach that connects leading-edge treatment options with personalized care across gastroenterology and GI surgery.

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