Nonalcoholic Fatty Liver Disease
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
oral administration, 100mg bid
DRUGMB12066 200mg
oral administration, 100mg bid
Sponsors
Yungjin Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* NAFLD Activity Score(NAS) ≥ 3 (Biopsy-proven)
Exclusion criteria
* Alcohol consumption \> 20g/day * Type 1 diabetes or poorly controlled diabetes mellitus (HbA1c ≥ 9%) * Evidence of other chronic liver disease (e.g. HBsAg positive, anti-HCV positive, autoimmune hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency and etc.) * ALT, AST \> 5X the upper limit of normal * Serum creatinine ≥ 2mg/dl * Fibrosis score ≥ 3 according to the NASH CRN fibrosis staging system * NQO1 T/T type * Weight loss of more than 5kg within 6 months * Bariatric surgery within 6 months * Known alcohol or any other drug abuse in the last five years * Insulin sensitizers, hepatoprotective agents, anti-oxidants, lipid-lowering agents, drugs induced fatty liver within 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hepatic steatosis(%) | baseline, 12 weeks | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Change in fibrosis score | baseline, 12 weeks |
| Change in steatosis score | baseline, 12weeks |
| Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS) | baseline, 12 weeks |
| Change in ballooning score | baseline, 12weeks |
| Change in lipid profile | baseline, 4weeks, 8weeks, 12weeks |
| Change in lobular inflammation score | baseline, 12weeks |
Countries
South Korea
Outcome results
None listed