This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
oral administration, 100mg bid
oral administration, 100mg bid
Seoul St. Mary's Hospital
Seoul, Banpo-daero Seocho-gu, South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, Cheonbo-ro Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, South Korea
Change in hepatic steatosis(%)
The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).
Time frame: baseline, 12 weeks
Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)
Time frame: baseline, 12 weeks
Change in fibrosis score
Time frame: baseline, 12 weeks
Change in steatosis score
Time frame: baseline, 12weeks
Change in lobular inflammation score
Time frame: baseline, 12weeks
Change in ballooning score
Time frame: baseline, 12weeks
Change in lipid profile
Time frame: baseline, 4weeks, 8weeks, 12weeks
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Keimyung University Donsan Medical Center
Daegu, Dalseong-ro Jung-gu, South Korea
Kyungpook National University Hospital
Daegu, Dongdeok-ro Jung-gu, South Korea
Chung-ang University Hospital
Seoul, Heukseok-dong Dongjak-gu, South Korea
ASAN Medical Center
Seoul, Olympic-ro 43-gil, Songpa-gu, South Korea
Boramae Hospital
Seoul, Sindaebang-dong Dongjak-gu, South Korea
Hanyang University Medical Center
Seoul, Wangsimni-ro Seongdong-gu, South Korea
Severance Hospital
Seoul, Yonsei-ro Seodaemun-gu, South Korea