Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Key Inclusion Criteria:

   - Liver biopsy consistent with cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH)
   in the opinion of the central reader. In individuals 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%

      - International normalized ratio (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

   - Body mass index (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 hepatitis B virus (HBV) infection (HBsAg positive), or Chronic hepatitis C
   virus (HCV) infection (HCV antibody and HCV ribonucleic acid (RNA) positive).
   Individuals 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 (1 unit is equivalent to 12 ounce (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 individuals who have not completed a series of an authorized coronavirus disease
   2019 (COVID-19) vaccination regimen prior to screening, a positive result for COVID-19
   on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse
   transcriptase-polymerase chain reaction (RT-PCR) test.

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