The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.
Subjects will be randomized to the study group 1 (J2H-1702 A mg), study group 2 (J2H-1702 B mg), study group 3 (J2H-1702 C mg), or control group (placebo of J2H-1702) in a 1:1:1:1 ratio and administered the investigational product (IP) for 12 weeks. After the IP administration, the safety and efficacy will be evaluated at V4, V8 and V12 (end of treatment, EOT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
87
Dong-A University Hospital
Busan, South Korea
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, South Korea
Changes from baseline in results on MRI-PDFF at week12.
The liver fat content(%) on MRI-PDFF at week 12 after administration of the IP are evaluated.
Time frame: Baseline and week12
Changes from baseline in results on MRE at week12.
The liver fibrosis (kPa) on MRE at week 12 after administration of the IP are evaluated.
Time frame: Baseline and week12
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Orally, once daily before meals
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