A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are:
Key Inclusion Criteria:
Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader
In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 at Screening
Screening laboratory parameters, as determined by the central laboratory:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply
Sacramento, California 95817, United States
Manhasset, New York 11030, United States
Charlotte, North Carolina 28204, United States
Philadelphia, Pennsylvania 19104, United States
Pittsburgh, Pennsylvania 15213, United States
Dallas, Texas 75390, United States
Falls Church, Virginia 22042, United States
Richmond, Virginia 23226, United States
Montreal, H4A 3J1, Canada