Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)



Status:Completed
Conditions:Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:1/31/2019
Start Date:October 26, 2016
End Date:January 9, 2018

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)

The primary objective of this study is to evaluate the safety and tolerability 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
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Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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Arlington, Texas 76012
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Atlanta, Georgia 30342
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Calgary, Alberta
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Chicago, Illinois 60611
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Coral Gables, Florida 33134
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Germantown, Tennessee 38138
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6550 Fannin St
Houston, Texas 77030
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425 Volker Boulevard
Kansas City, Missouri 64131
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Live Oak, Texas 78233
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Los Angeles, California 90036
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Metairie, Louisiana 70006
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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Rialto, California 92377
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