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

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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).


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.
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Statesville, North Carolina 28677
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