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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491905
• Other study ID #: 12-HS-HP-09-1
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2015
• Last updated: July 2, 2015
• Start date: November 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Huons Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• HL tablet

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Huons	Ansan	Kyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline		12 weeks	No
Secondary	Changes in Alanine Transaminase (ALT)		8 and 12 week	No
Secondary	Changes in Asparate Transaminase (AST)		8 and 12 week	No
Secondary	Changes in cholesterol		8 and 12 week	No
Secondary	Changes in triglyceride		8 and 12 week	No
Secondary	Changes in free fatty acid		8 and 12 week	No
Secondary	Changes in insulin resistance		8 and 12 week	No
Secondary	Changes in Body Mass Index (BMI)		8 and 12 week	No