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Phase II

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

  • Study HIC#:2000027577
  • Last Updated:07/26/2021

This research study is for people who may have abnormally high amount of fat and swelling (inflammation) of their liver along with some fibrosis (scarring) that is not related to excessive alcohol consumption. The medical term for this condition is nonalcoholic steatohepatitis (NASH) that has both high liver fat and inflammation (swelling) and fibrosis (scarring) that causes a stiff liver. This research study involves two investigational drugs (study drugs) as potential options to treat patients with NASH with liver fibrosis.

  • Age18 years - 75 years
  • GenderBoth
  • Start Date01/08/2021
  • End Date11/01/2022

Eligibility Criteria

Inclusion Criteria:

  • 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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