A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).
Key Inclusion Criteria:
Meets all of the following conditions:
A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kPa
A historical liver biopsy consistent with NASH and non-cirrhotic fibrosis
Platelet count ≥ 100,000/mm^3
Creatinine Clearance (CLcr ) as calculated by the Cockcroft-Gault equation ≥ 60 ml/min
Key Exclusion Criteria:
Pregnant or lactating females
Alanine aminotransferase (ALT) > 5 x upper limit of the normal range (ULN)
Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
Cirrhosis of the liver
Body mass index (BMI) < 18 kg/m^2
International normalized ratio (INR) > 1.2 unless on anticoagulant therapy
Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.