Overview
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
Eligibility
Inclusion Criteria:
- Able to understand and comply with study procedures and give written informed consent
- Age ≥18 years
- NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
- Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
- Meet all inclusion criteria outlined in clinical study protocol
Exclusion Criteria:
- Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
- Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol
- Evidence of other forms of chronic liver disease as defined in clinical study protocol
- Does not meet any other exclusion criteria outlined in clinical study protocol