GS-0976 in Adults With Nonalcoholic Steatohepatitis
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 7/13/2018 |
Start Date: | August 8, 2016 |
End Date: | July 18, 2017 |
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 GS-0976 in
adults with nonalcoholic steatohepatitis (NASH).
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
- OR
- 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
- Prior history of decompensated liver disease, including ascites, hepatic
encephalopathy or variceal bleeding
- 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.
We found this trial at
30
sites
303 Twin Dolphin Drive
Foster City, California 94065
Foster City, California 94065
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