A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
Key Inclusion Criteria:
Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH Clinical Research Network (CRN) classification in the opinion of the central reader
Has the following laboratory parameters at the screening visit:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
San Francisco, California 94115, United States
Buffalo, New York 14230, United States
Manhasset, New York 11030, United States
Chapel Hill, North Carolina 27599, United States
Huntersville, North Carolina 28078, United States
Statesville, North Carolina 28625, United States
Philadelphia, Pennsylvania 19104, United States
Pittsburgh, Pennsylvania 15213, United States
Greenville, South Carolina 29605, United States
Nashville, Tennessee 37212, United States
Newport News, Virginia 23602, United States
Richmond, Virginia 23226, United States
Botucatu, 18618-000, Brazil
Ribeirão Preto, 14048-900, Brazil
São Paulo, 01246-903, Brazil
São Paulo, 04040-003, Brazil
Edmonton, Alberta T6G 2X8, Canada
Montreal, Quebec H4A 3JI, Canada
Mumbai, 400012, India
Shinjuku-ku, 162-8655, Japan
Bytom, 41-902, Poland
Bern, 3010, Switzerland