Inclusion Criteria:  Willing to participate in the study and provide written informed consent. Male and female adults aged > 18 years. Must have NASH and fibrosis on a liver biopsy sample If a historical liver biopsy is used for Screening, obtained within 6 months prior to Screening; Subjects may have a diagnosis of T2DM  Exclusion Criteria:  History or presence of liver disease (other than NAFLD or NASH) History or presence of cirrhosis and/or history or presence of hepatic decompensation