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

Huons

Status and phase: Completed; Phase 2

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Drug: Placebo; Drug: HL tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02491905

12-HS-HP-09-1

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 3 patient groups, including a placebo group

low dose HL tablet

Experimental group

Description:

HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal

Treatment:

Drug: HL tablet

high dose HL tablet

Experimental group

Description:

HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal

Treatment:

Drug: HL tablet

placebo group

Placebo Comparator group

Description:

Placebo by oral administration, twice daily in an hour after meal

Treatment:

Drug: Placebo