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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MB12066 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MB12066 200mg | Drug | oral administration, 100mg bid |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS) | baseline, 12 weeks | |
| Change in fibrosis score | baseline, 12 weeks | |
| Change in steatosis score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | Banpo-daero Seocho-gu | 137-701 | South Korea | ||
| Uijeongbu St. Mary's Hospital |
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| Drug |
oral administration, 100mg bid |
|
| baseline, 12weeks |
| Change in lobular inflammation score | baseline, 12weeks |
| Change in ballooning score | baseline, 12weeks |
| Change in lipid profile | baseline, 4weeks, 8weeks, 12weeks |
| Uijeongbu-si |
| Cheonbo-ro Gyeonggi-do |
| 480-710 |
| South Korea |
| Seoul National University Hospital | Seoul | Daehak-ro Jongno-gu | 110-744 | South Korea |
| Keimyung University Donsan Medical Center | Daegu | Dalseong-ro Jung-gu | 700-712 | South Korea |
| Kyungpook National University Hospital | Daegu | Dongdeok-ro Jung-gu | 700-721 | South Korea |
| Chung-ang University Hospital | Seoul | Heukseok-dong Dongjak-gu | 156-755 | South Korea |
| ASAN Medical Center | Seoul | Olympic-ro 43-gil, Songpa-gu | 138-736 | South Korea |
| Boramae Hospital | Seoul | Sindaebang-dong Dongjak-gu | 156-707 | South Korea |
| Hanyang University Medical Center | Seoul | Wangsimni-ro Seongdong-gu | 133-792 | South Korea |
| Severance Hospital | Seoul | Yonsei-ro Seodaemun-gu | 120-752 | South Korea |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C014638 | beta-lapachone |
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