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
Phase II
All Other
Kris Kowdley, M.D.
Gilead Sciences, Inc.
Sheri Soo
  • Swedish Medical Center