Safety, Tolerability, and Efficacy of GS 9674 in Adults With Primary Biliary Cholangitis Without Cirrhosis

Key Inclusion Criteria:

- Meets all of the following conditions

- Definite or probable PBC as defined by at least 2 of the 3 following criteria:

- Serum alkaline phosphatase (ALP) > the upper limit of normal (ULN)

- Presence of anti-mitochondrial antibodies (AMA) in serum (≥ 1:40 on
immunofluorescence)

- Liver histological (based on liver biopsy) findings consistent with PBC
including nonsuppurative, destructive cholangitis affecting mainly the
interlobular bile and septal bile ducts

- Serum ALP > 1.67 x ULN and/or total bilirubin >ULN but ≤ 2 x ULN

- Ursodeoxycholic acid (UDCA) use at a stable dose for at least 12 months or
intolerant of UDCA with no UDCA use for at least 12 months before screening

- Screening FibroSURE/FibroTest® < 0.75 unless a historical liver biopsy within 12
months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or
hemolysis, FibroSURE/FibroTest® will be using direct bilirubin instead of total
bilirubin.

Key Exclusion Criteria:

- Alanine aminotransferase (ALT) > 5 x ULN

- Total bilirubin > 2 x ULN

- International normalized ratio (INR) > 1.2 unless on anticoagulant therapy

- Other causes of liver disease including viral, metabolic, alcoholic, and other
autoimmune conditions. Participants with hepatic steatosis may be included if there is
no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator
or on liver biopsy.

- Use of fibrates or obeticholic acid within 3 months prior to screening through the end
of treatment

- Cirrhosis of the liver as defined by any of the following:

- Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak
stage ≥ 5)

- History of decompensated liver disease, including ascites, hepatic encephalopathy
or variceal bleeding

- Liver stiffness > 16.9 kPa by FibroScan

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