Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and GS-9674 in Adults With Nonalcoholic Steatohepatitis (NASH)



Status:Active, not recruiting
Conditions:Gastrointestinal, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/20/2019
Start Date:July 13, 2016
End Date:July 2019

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A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)

The primary objective of this study is to evaluate the safety and tolerability of selonsertib
(SEL; formerly GS-4997), firsocostat, GS-9674 and /or fenofibrate in adults with nonalcoholic
steatohepatitis (NASH).


Key Inclusion Criteria:

- Males and females between 18-75 years of age (Cohorts 1-9: 18-75 years and Cohorts
10-11: ≥ 18 years); inclusive based on the date of the screening visit

- Willing and able to provide informed consent prior to any study specific procedures
being performed

- Meets the following conditions (Cohorts 1-6 and 9):

- Clinical diagnosis of non-alcoholic fatty liver disease and evidence of F2-3
fibrosis

- For Cohorts 7 and 8, participants must have a clinical diagnosis of NAFLD and
cirrhosis

- For Cohorts 10 and 11, individuals must have a clinical diagnosis of NAFLD and meet
one of the following criteria :

- a) A historical liver biopsy within 6 months of Screening consistent with NASH
and bridging fibrosis (F3) or within 12 months of Screening consistent with NASH
and compensated cirrhosis (F4) in the opinion of the investigator,

- b) Screening liver stiffness by MRE ≥ 3.64 kPa;

- c) Screening liver stiffness by FibroScan® ≥ 9.9 kPa;

Key Exclusion Criteria:

- Pregnant or lactating females

- Other causes of liver disease including autoimmune, viral, and alcoholic liver disease

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

- For Cohorts 7 and 8, Child-Pugh-Turcotte (CPT) score > 6

- History of liver transplantation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
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