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

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

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.

Inclusion Criteria:

1. Age between 19 and 75

2. Non-alcoholic fatty liver disease patient

   • Diagnosed by abdomen ultrasonic examination
   • Non-drinker (alcohol intake per week : female-under 140g, male-under 210g)

3. ALT or AST higher than normal range (not over 4 times normal range)

4. Voluntary agreement and enrollment

Exclusion Criteria:

1. The ratio of AST/ALT over 2
2. Type I diabetes mellitus patient
3. Any dysfunction of liver besides non-alcoholic fatty liver disease
4. Alcoholic fatty liver disease patient or heavy drinker
5. Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months
6. Patient taking any product which affects the BMI or hyperlipidemia
7. Any dyscrasia that investigator considers not to appropriate for this study
8. Bariatric surgery within 6 months
9. Any disease which is able to change the distribution of cytokines
10. Any treatment that affects liver functions within 1 month
11. Participation in other clinical trials within 3 months
12. Person who can not use MRS
13. Pregnancy or breast-feeding
14. Fertile women who do not use contraception
15. Sensitive to the investigational product
16. Any conditions that the investigator considers not to appropriate for this study