Back to resultsSafety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL tablet
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease
Eligibility Criteria
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
Sites / Locations
- Huons
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
low dose HL tablet
high dose HL tablet
placebo group
Arm Description
HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal
HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal
Placebo by oral administration, twice daily in an hour after meal
Outcomes
Primary Outcome Measures
To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline
Secondary Outcome Measures
Changes in Alanine Transaminase (ALT)
Changes in Asparate Transaminase (AST)
Changes in cholesterol
Changes in triglyceride
Changes in free fatty acid
Changes in insulin resistance
Changes in Body Mass Index (BMI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02491905
Brief Title
Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huons Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low dose HL tablet
Arm Type
Experimental
Arm Description
HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal
Arm Title
high dose HL tablet
Arm Type
Experimental
Arm Description
HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo by oral administration, twice daily in an hour after meal
Intervention Type
Drug
Intervention Name(s)
HL tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Alanine Transaminase (ALT)
Time Frame
8 and 12 week
Title
Changes in Asparate Transaminase (AST)
Time Frame
8 and 12 week
Title
Changes in cholesterol
Time Frame
8 and 12 week
Title
Changes in triglyceride
Time Frame
8 and 12 week
Title
Changes in free fatty acid
Time Frame
8 and 12 week
Title
Changes in insulin resistance
Time Frame
8 and 12 week
Title
Changes in Body Mass Index (BMI)
Time Frame
8 and 12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Huons
City
Ansan
State/Province
Kyeonggi-do
ZIP/Postal Code
426791
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
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