SHS_610054 KOWK CGIL 17045
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH)
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH).
Key Inclusion Criteria:
Meets 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 kilopascal (kPa) OR
• A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
• No documented weight loss > 5% between the date of the liver biopsy and screening.
• Platelet count ≥ 150,000/mm^3
• Albumin ≥ 3.3 g/dL
• Serum creatinine ≤ upper limit of normal (ULN)
Key Exclusion Criteria:
• Pregnant or lactating females
• Alanine aminotransferase (ALT) > 5x upper limit of the normal range (ULN)
• Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
• Cirrhosis of the liver
• Prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
• Body mass index (BMI) < 18 kg/m^2
• Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)
• International normalized ratio (INR) > 1.2 unless on anticoagulant therapy
• Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome
Kris Kowdley, M.D.
Gilead Sciences, Inc.