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.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Placebo; Drug: HL tablet

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyeonggi-do
    • Ansan, Kyeonggi-do, Korea, Republic of, 426791
      • Huons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low dose HL tablet; HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal	Drug: HL tablet
Experimental: high dose HL tablet; HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal	Drug: HL tablet
Placebo Comparator: placebo group; Placebo by oral administration, twice daily in an hour after meal	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 2, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 12-HS-HP-09-1