Ensayos clínicos

Key Inclusion Criteria:

- 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/1.73m^2, 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/m^2 at screening.

Key Exclusion Criteria:

- 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.