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

Phase 2

Completed

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Drug: HL tablet; Drug: Placebo

• Registration Number: NCT02491905
• Lead Sponsor: Huons Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2015-06-24
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Study First Posted: 2015-07-08
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose HL tablet	HL tablet	HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal
placebo group	Placebo	Placebo by oral administration, twice daily in an hour after meal
high dose HL tablet	HL tablet	HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in insulin resistance	8 and 12 week
Changes in Alanine Transaminase (ALT)	8 and 12 week
Changes in triglyceride	8 and 12 week
Changes in free fatty acid	8 and 12 week
Changes in Asparate Transaminase (AST)	8 and 12 week
Changes in cholesterol	8 and 12 week
Changes in Body Mass Index (BMI)	8 and 12 week

Trial Locations

Locations (1)

Huons; 🇰🇷 Ansan, Kyeonggi-do, Korea, Republic of