Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3



Status:Active, not recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:June 2015
End Date:October 2016

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A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

This study will evaluate the safety and tolerability of GS-4997 alone or in combination with
Simtuzumab (SIM) in adults with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages
F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.


Inclusion Criteria:

- Males and non-pregnant, non-lactating females

- Evidence of NASH with fibrosis on biopsy

Exclusion Criteria:

- Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)

- Other causes of liver disease including viral hepatitis and alcoholic liver disease

- Any history of decompensated liver disease, including ascites, hepatic encephalopathy
or variceal bleeding

- History of liver transplantation

- Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1
oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine,
and a 1 oz/30 mL measure of 40% proof alcohol)
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San Diego, California 92093
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330 Brookline Ave
Boston, Massachusetts 02215
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13001 E. 17th Pl
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Calgary, Alberta
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303 East Superior Street
Chicago, Illinois 60611
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2301 Erwin Rd
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340 W 10th St #6200
Indianapolis, Indiana 46202
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425 Volker Boulevard
Kansas City, Missouri 64131
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5121 S Cottonwood St
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Newport News, Virginia 23602
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5300 Tallman Ave NW
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