Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled
study in subjects with compensated cirrhosis.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
NASH and compensated cirrhosis
Enrollment Eligibility
Key Inclusion Criteria:
1. Liver biopsy consistent with NASH cirrhosis.
2. Compensated cirrhosis due to NASH.
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.