Non-alcoholic Fatty Liver DiseasePhase 2NCT02491905
Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
A Phase 2 study testing HL tablet in people with Non-alcoholic Fatty Liver Disease, run by Huons Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- HL tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- HL tablet, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL tabletDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| low dose HL tablet | Experimental | HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal Receives: Drug: HL tablet |
| high dose HL tablet | Experimental | HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal Receives: Drug: HL tablet |
| placebo group | Placebo comparator | Placebo by oral administration, twice daily in an hour after meal Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline
Measured: 12 weeks
Secondary outcomes (7)
Changes in Alanine Transaminase (ALT)
Measured: 8 and 12 week
Changes in Asparate Transaminase (AST)
Measured: 8 and 12 week
Changes in cholesterol
Measured: 8 and 12 week
Changes in triglyceride
Measured: 8 and 12 week
Changes in free fatty acid
Measured: 8 and 12 week
Changes in insulin resistance
Measured: 8 and 12 week
Changes in Body Mass Index (BMI)
Measured: 8 and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491905
- Sponsor's protocol ID
- 12-HS-HP-09-1
- Status last verified
- Jul 2015
- First submitted
- 24 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Assess Safety and Efficacy of HL Tablet on Reducing Hepatic Fat in Non-alcoholic Fatty Liver Disease Patients
- ClinicalTrials.gov ID
- NCT02491905
- Acronym / sponsor ID
- 12-HS-HP-09-1
- Conditions
- Non-alcoholic Fatty Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose HL tablet | Experimental | Drug: HL tabletHL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal |
| high dose HL tablet | Experimental | Drug: HL tabletHL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal |
| placebo group | Placebo comparator | Drug: PlaceboPlacebo by oral administration, twice daily in an hour after meal |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 19 and 75
- Non-alcoholic fatty liver disease patient
- ALT or AST higher than normal range (not over 4 times normal range)
- Voluntary agreement and enrollment
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL tablet | Drug | high dose HL tablet, low dose HL tablet |
| Placebo | Drug | placebo group |
Primary outcome
To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline
Time frame: 12 weeks
7 secondary outcomes
Changes in Alanine Transaminase (ALT)
Time frame: 8 and 12 week
Changes in Asparate Transaminase (AST)
Time frame: 8 and 12 week
Changes in cholesterol
Time frame: 8 and 12 week
Changes in triglyceride
Time frame: 8 and 12 week
Changes in free fatty acid
Time frame: 8 and 12 week
Changes in insulin resistance
Time frame: 8 and 12 week
Changes in Body Mass Index (BMI)
Time frame: 8 and 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HL tablet in people with Non-alcoholic Fatty Liver Disease, run by Huons Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.