Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    450
  • sponsor
    Pfizer
Updated on 19 November 2020
fibrosis
hepatic fibrosis
steatohepatitis

Summary

The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).

Details
Treatment Placebo, PF-06865571, PF-05221304
Clinical Study IdentifierNCT04321031
SponsorPfizer
Last Modified on19 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease or Non-alcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis With Live...?
Do you have any of these conditions: Nonalcoholic Steatohepatitis With Liver Fibrosis or Nonalcoholic Fatty Liver Disease or NAFLD or Nonalcoholic Steatohepatitis (NASH) or non-alcoholic ...?
Do you have any of these conditions: Non-alcoholic Fatty Liver Disease or NAFLD or Nonalcoholic Steatohepatitis (NASH) or non-alcoholic fatty liver or Nonalcoholic Steatohepatitis With Li...?
Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
BMI >/= 22.5kg/m2

Exclusion Criteria

Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
unstable liver function tests, recent cardiovascular event(s) significant malignancies
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