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Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

A Phase 2b, Prospective, Multicenter, Randomized, Double-Blind, Placebocontrolled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis

  • Clinical Trial Information

    Trial Contact: Shepherd, Adriane R; Garcia de Djuro, Ginette

    Trial Phone: 321 841-2285 ; 321.841.6649

  • IRB No: SSU00234213

    Protocol Abbrev: SARO-20-002

    Principal Investigator: Arvind R. Murali, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: SARO.20.002

    Treatment: Drug: Saroglitazar Magnesium 4 mg Drug: Saroglitazar Magnesium 2 mg

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT05011305

  • Objective

    To evaluate the effect of Saroglitazar Magnesium (2 mg and 4 mg) compared with Placebo on resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis at Week 76/EOT.

  • Key Eligibility

    Subjects are eligible to be included in the study only if all of the following criteria apply:
    1. Males or females, between 18 and 75 years of age, both inclusive at screening.
    2. BMI ≤45 kg/m²
    3. Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver
    biopsy with a NAS ≥4 with at least one-point score in each of the three components of the NAFLD
    activity score [NAS] (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular
    inflammation scored 0-3) and NASH by pattern recognition
    Note: The biopsy must not have been performed more than 24 weeks before randomization.
    4. The subjects must have a stable body weight (no more than 5% change) between the time of biopsy
    and randomization.
    5. Fibrosis stage 2 and 3, according to the NASH CRN fibrosis staging, reported by central
    pathologist.
    6. If the subjects have type 2 diabetes mellitus, then it must be moderately controlled with
    HbA1c ≤ 9.5% and on a stable dose of permitted anti-diabetic medication for at least 90 days before
    screening.
    7. If the subjects are taking Vitamin E > 400 IU/day, then it must be on a stable dose for at least 24
    weeks prior to screening or, if a historical biopsy is used, at least 24 weeks prior to baseline liver
    biopsy until time of screening.
    8. Must provide written informed consent and agree to comply with the trial protocol.