Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)

For people ages 18-75

Key Inclusion Criteria:

1. Liver biopsy consistent with fibrosis stage 4 (F4) cirrhosis.
2. Compensated cirrhosis due to NASH.
3. Total liver fat content of ≥ 8% as measured by MRI-PDFF.

Key Exclusion Criteria:

1. Other causes of liver disease including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, primary biliary cirrhosis, drug-induced hepatotoxicity, Wilson's disease, hemochromatosis, and alpha-1-anti-trypsin definition based on medical history and/or centralized read of liver histology.
2. Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis.
3. History of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy.
4. Model of end stage liver disease (MELD) score >12.

Other protocol-defined inclusion/exclusion criteria could apply.