Clinical Trials

Inclusion Criteria:

- United States Sites: Adults ≥ 18 to ≤ 70 years.

- Korean Sites: Adults ≥ 19 to ≤ 70 years.

- BMI ≥ 18 kg/m2, with stable body weight (defined as change < 5%) by history for 3
months prior to screening or since baseline liver biopsy, whichever is earlier.

- Subjects have a diagnosis of noncirrhotic NASH with liver fibrosis (Fibrosis stage
F1-F3) confirmed by liver biopsy within 6 months of Day -7.

- MRI-PDFF performed at screening with ≥ 8% steatosis.

Exclusion Criteria:

- Subjects with a history of active or chronic liver disease, including alcoholic liver
disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis,
autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin
deficiency, human immunodeficiency virus (HIV).

- Any history of clinically significant chronic liver disease including esophageal
varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for
treatment of chronic liver disease; or Model for End Stage Liver Disease >12.

- Recent (within 3 months of baseline biopsy) use of therapies associated with
development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen,
aromatase inhibitors, amiodarone, or long-term use of tetracyclines).

- Type 1 diabetes subjects, or T2DM subjects on insulin and/or GLP-1 receptor agonist
therapy, or other therapies not allowed for this study

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/30/2024. Questions regarding updates should be directed to the study team contact.