| Outcome Measures: |
Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)|Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug|Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa)|Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, ??-GTP in IU/L)|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)|Change in noninvasive biomarkers (NAFLD fibrosis score)|Change in noninvasive biomarkers (FIB4 index)|Change in noninvasive biomarkers (NAFIC score)|Change in noninvasive biomarkers (ELF test)|Percentage of patients with ??? 30% reduction in hepatic fat fraction (MRI-PDFF)|Percentage of patients with ??? 15% reduction in liver stiffness (MRE)
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| Locations: |
Aomori Prefectural Central Hospital, Aomori, Aomori, Japan|Asahikawa Medical University, Asahikawa, Hokkaido, Japan|Fukuwa Clinic, 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|Ogaki Municipal Hospital, Ogaki, Gifu, Japan|Shiga University of Medical Science Hospital, Otsu, Shiga, Japan|Hokkaido University Hospital, Sapporo, Hokkaido, Japan|Yamagata University Hospital, Yamagata, Yamagata, Japan|Saiseikai Yokohamashi Tobu Hospital, Yokohama, Kanagawa, Japan|Yokohama City University Hospital, Yokohama, Kanagawa, Japan
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