Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients

Study Overview
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Brief Summary
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This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low dose, high dose, and placebo control group.

Official Title
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Phase 2 Study to Assess Safety and Efficacy of HL Tablet on Reducing Hepatic Fat in Non-alcoholic Fatty Liver Disease Patients

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: HL tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 19 and 75 Non-alcoholic fatty liver disease patient Diagnosed by abdomen ultrasonic examination Non-drinker (alcohol intake per week : female-under 140g, male-under 210g) ALT or AST higher than normal range (not over 4 times normal range) Voluntary agreement and enrollment Exclusion Criteria: The ratio of AST/ALT over 2 Type I diabetes mellitus patient Any dysfunction of liver besides non-alcoholic fatty liver disease Alcoholic fatty liver disease patient or heavy drinker Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months Patient taking any product which affects the BMI or hyperlipidemia Any dyscrasia that investigator considers not to appropriate for this study Bariatric surgery within 6 months Any disease which is able to change the distribution of cytokines Any treatment that affects liver functions within 1 month Participation in other clinical trials within 3 months Person who can not use MRS Pregnancy or breast-feeding Fertile women who do not use contraception Sensitive to the investigational product Any conditions that the investigator considers not to appropriate for this study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: low dose HL tablet<br>HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal | Drug: HL tablet<br> <br> |
| Experimental: high dose HL tablet<br>HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal | Drug: HL tablet<br> <br> |
| Placebo Comparator: placebo group<br>Placebo by oral administration, twice daily in an hour after meal | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Alanine Transaminase (ALT) |  | 8 and 12 week | 
| Changes in Asparate Transaminase (AST) |  | 8 and 12 week | 
| Changes in cholesterol |  | 8 and 12 week | 
| Changes in triglyceride |  | 8 and 12 week | 
| Changes in free fatty acid |  | 8 and 12 week | 
| Changes in insulin resistance |  | 8 and 12 week | 
| Changes in Body Mass Index (BMI) |  | 8 and 12 week |