A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)
This will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PKs, and efficacy of CS0159 in the treatment of patients with NASH over 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Oral QD
National Research Institute - Gardena
Gardena, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
MRI-PDFF
To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12
Time frame: Week 12
Adverse events
To evaluate the safety and tolerability of CS0159 in patients with NASH treated over 12 weeks
Time frame: Week 12
Cmax
maximum concentration (Cmax) from baseline to Week 12
Time frame: week 6, week 12
tmax
time to maximum plasma concentration (tmax) from baseline to Week 12
Time frame: week 6, week 12
t1/2
half-life (t1/2) from baseline to Week 12
Time frame: week 6, week 12
AUC
accumulation ratio of area under the concentration-time curve (AUC) in plasma from baseline to Week 12
Time frame: week 6, week 12
Pharmacodynamics (PD)
Plasma concentrations and PD parameters of the biomarkers of FXR target engagement fibroblast growth factor 19 and 7α-hydroxy-4-cholesten-3-one (C4) from baseline to Week 12
Time frame: week 6, week 12
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