The primary objectives of this study are: * To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH * To evaluate changes in liver fibrosis, without worsening of NASH
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
395
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose date up to 48 weeks plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Time frame: First dose date up to 48 weeks plus 30 days
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method.
Time frame: Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablet administered orally once daily without regard to food
Tablet administered orally once daily without regard to food
Tablet administered orally once daily without regard to food
The Institute for Liver Health
Chandler, Arizona, United States
Mayo Clinic Arizona, Mayo Clinic Hospital
Phoenix, Arizona, United States
Liver Wellness Center
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
eStudySite
Chula Vista, California, United States
Southern California Liver Center
Coronado, California, United States
Fresno Clinical Research Center
Fresno, California, United States
UCSD NAFLD Clinical Research Center
La Jolla, California, United States
Ruane Clinical Research Group Inc.
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
...and 91 more locations