Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Therapeutic Exploratory Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) Except Cirrhosis

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: MB12066 200mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MB12066<br> | Drug: MB12066 200mg<br>* oral administration, 100mg bid<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral administration, 100mg bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | baseline, 12weeks | 
| Change in lobular inflammation score |  | baseline, 12weeks | 
| Change in ballooning score |  | baseline, 12weeks | 
| Change in lipid profile |  | baseline, 4weeks, 8weeks, 12weeks |