A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
Aomori Prefectural Central Hospital
Aomori, Aomori, Japan
Asahikawa Medical University
Asahikawa, Hokkaido, Japan
Fukuwa Clinic
Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame: Week 24
Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug
Time frame: Week 24
Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa)
Time frame: From baseline upto week 72
Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, γ-GTP in IU/L)
Time frame: From baseline upto week 72
Change in noninvasive biomarkers (Cytokeratin 18 in U/L, Hyaluronic acid in ng/mL, Type IV collagen 7S in ng/mL, M2BPGi in no unit)
Time frame: From baseline upto week 72
Change in noninvasive biomarkers (NAFLD fibrosis score)
Time frame: From baseline upto week 72
Change in noninvasive biomarkers (FIB4 index)
Time frame: From baseline upto week 72
Change in noninvasive biomarkers (NAFIC score)
Time frame: From baseline upto week 72
Change in noninvasive biomarkers (ELF test)
Time frame: From baseline upto week 72
Percentage of patients with ≥ 30% reduction in hepatic fat fraction (MRI-PDFF)
Time frame: From baseline upto week 72
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Chuo-ku, Tokyo, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
SeireiHamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Iwata City Hospital
Iwata, Shizuoka, Japan
Chutoen General Medical Center
Kakegawa, Shizuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
...and 6 more locations
Percentage of patients with ≥ 15% reduction in liver stiffness (MRE)
Time frame: From baseline upto week 72