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

Sponsor

Huons Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02491905

Collaborator

(none)

Enrollment

Location

Arms

17.9

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Fatty Liver Disease	Drug: HL tablet Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 19 and 75
Non-alcoholic fatty liver disease patient

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

ALT or AST higher than normal range (not over 4 times normal range)
Voluntary agreement and enrollment

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huons	Ansan	Kyeonggi-do	Korea, Republic of	426791

Sponsors and Collaborators

Huons Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huons Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02491905

Other Study ID Numbers:

12-HS-HP-09-1

First Posted:

Jul 8, 2015

Last Update Posted:

Jul 8, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jul 8, 2015