A Study of a New Investigational Treatment Combination for NASH

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Open to people ages 18-80

• Liver biopsy consistent with cirrhosis (F4) due to NASH in the opinion of the central reader. In participants who have never had a liver biopsy, a screening liver biopsy may be performed
• Screening laboratory parameters as determined by the study central laboratory:
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m², as calculated by the Modification of Diet in Renal Disease (MDRD) equation
  • HbA1c ≤ 10%
  • INR ≤ 1.4, unless due to therapeutic anticoagulation
  • Platelet count ≥ 125,000/uL
  • Alanine Aminotransferase (ALT) < 5 x ULN
  • Serum albumin ≥ 3.5 g/dL
  • Serum Alkaline Phosphatase (ALP) ≤ 2 x ULN
• BMI ≥ 23 kg/m² at screening

• Prior history of decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal bleeding
• Child-Pugh (CP) score > 6 at screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
• Model for End-stage Liver Disease (MELD) score > 12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation
• Other causes of liver disease based on medical history and/or central reader review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
• Chronic HBV infection (HBsAg positive), or Chronic HCV infection (HCV antibody and HCV RNA positive). Participants cured of HCV infection less than 2 years prior to the screening visit are not eligible
• History of liver transplantation
• Current or prior history of hepatocellular carcinoma (HCC)
• Men who habitually drink greater than 21 units/week of alcohol or women who habitually drink greater than 14 units/week of alcohol (one unit is equivalent to 12 oz/360 mL of beer, a 4 oz/120 mL glass of wine, or 1 oz/30 mL of hard liquor).
  • For individuals on vitamin E regimen ≥ 800 IU/day, or pioglitazone, dose must be stable, in the opinion of the investigator for at least 180 days prior to the historical or screening liver biopsy
  • For individuals on medications for diabetes, dose must be stable, in the opinion of the investigator, for at least 90 days prior to the historical or screening liver biopsy
• History of type 1 diabetes
• Treatment with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the period from 90 days prior to the screening visit and for individuals with a qualifying historical liver biopsy, for 90 days prior to the date of the historical liver biopsy
• For participants who have not completed a series of an authorized COVID-19 vaccination regimen prior to screening, a positive result for COVID-19 on SARS-CoV-2 RT-PCR test

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