Non-alcholic Fatty Liver DiseasePhase 3NCT02068339
Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
A Phase 3 study testing Oltipraz 1 (90mg) and Oltipraz 2 (120mg) in people with Non-alcholic Fatty Liver Disease, run by PharmaKing at 5 sites in South Korea.
Trial summary
Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Non-alcholic Fatty Liver Disease
- What is being tested?
- Oltipraz 1 (90mg) and Oltipraz 2 (120mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 283 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Feb 2014to Mar 2016
- Phase
- Phase 3
- 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
- Patients over 19 under 75 years of age
- Patients with non-alcoholic fatty liver disease except for cirrhosis
- Patients who have abnormal ALT, AST
- Patients who are satisfied with laboratory test
- Patients who agree to contraception
- Patients who can keet the diet
Who cannot join
- Over 2 ratio of AST to ALT
- Type 1 diabetes mellitus (insulin-dependent diabetes mellitus) or Type 2 diabetes mellitus(not controlled)
- Disorder in liver function with an exception of non-alcoholic fatty liver
- Patients with malignant tumors
- Patients who have been taken drugs induced fatty liver within 8 weeks of participation in this study
- Patients who has been taken any medications that could affect the treatment for NAFLD within 4 weeks
Show all 16Show fewer
- Patients who have been taken Vitamin E (≥ 800 IU/day), thiazolidinediones, orlistat within 12 weeks
- Patients who had a Bariatric surgery less than 6 month prior to the participation in the study
- Patients who are judged by investigator that participation of the study is difficult due to disease as follow;
- Any history of immune disorder
- Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
- Patient who has been administered other investigational product within 1 month prior to the participation in the study
- Patient who is not allowed to get MRS test: pacemaker, shunt and etc
- Pregnant or nursing women
- anti-HIV antibody (+)
- Patient who considered ineligible for participation in the study as Investigator's judgment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Hospital
Daehak-ro Jongno-gu, Seoul, 110-744
Inje University Ilsan Paik Hospital
Dahwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do, 411-706
Korea University Guro hospital
Gurodong-ro, Seoul, 152-703
NHUS Ilsan Hospital
Ilsan-ro Ilsan-donggu, Goyang-si, 410-719
Boramae Hospital
Sindaebang-dong Dongjak-gu, Seoul, 156-707
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.
- Conditions
- Non-alcholic Fatty Liver Disease
- Being tested
- Oltipraz 1 (90mg), Placebo, Oltipraz 2 (120mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oltipraz 1 (90mg)Drug
PlaceboDrug
Oltipraz 2 (120mg)Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Comparator / Tid (total 0mg) Receives: Drug: Placebo |
| Oltipraz 1 | Experimental | Total 90mg, by mouth, tid Receives: Drug: Oltipraz 1 (90mg) |
| Oltipraz 2 | Experimental | Total 120mg, by mouth, tid Receives: Drug: Oltipraz 2 (120mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRS(magnetic resonance spectroscopy)
To evaluate the efficacy of the Oltipraz on change in quantity of liver fat (% change) assessed by MRS from baseline to 24 weeks in patients.
Measured: 24 weeks
Secondary outcomes (7)
change in liver fat concentration
Measured: 24 weeks
change in BMI
Measured: 8, 16, 24 weeks
change in NAFLD Fibrosis score (NFS)
Measured: 24 weeks
change in ALT, AST, γ-GT
Measured: 8, 16, 24 weeks
change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG)
Measured: 8, 16, 24 weeks
change in HOMA-IR
Measured: 8, 16, 24 weeks
change in waist circumference
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcholic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaKing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068339
- Sponsor's protocol ID
- PMK-N01GI1_Phase 3
- Status last verified
- Mar 2016
- First submitted
- 19 Feb 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02068339
- Acronym / sponsor ID
- PMK-N01GI1_Phase 3
- Conditions
- Non-alcholic Fatty Liver Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- PharmaKingIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Feb 2014 (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.
Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator / Tid (total 0mg) |
| Oltipraz 1 | Experimental | Drug: Oltipraz 1 (90mg)Total 90mg, by mouth, tid |
| Oltipraz 2 | Experimental | Drug: Oltipraz 2 (120mg)Total 120mg, by mouth, tid |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 19 under 75 years of age
- Patients with non-alcoholic fatty liver disease except for cirrhosis
- Patients who have abnormal ALT, AST
- Patients who are satisfied with laboratory test
- Patients who agree to contraception
Key exclusion criteria (16 listed)
- Over 2 ratio of AST to ALT
- Type 1 diabetes mellitus (insulin-dependent diabetes mellitus) or Type 2 diabetes mellitus(not controlled)
- Disorder in liver function with an exception of non-alcoholic fatty liver
- Patients with malignant tumors
- Patients who have been taken drugs induced fatty liver within 8 weeks of participation in this study
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 |
|---|---|---|
| Oltipraz 1 (90mg) | Drug | Oltipraz 1 |
| Placebo | Drug | Placebo |
| Oltipraz 2 (120mg) | Drug | Oltipraz 2 |
Primary outcome
MRS(magnetic resonance spectroscopy)
Time frame: 24 weeks
To evaluate the efficacy of the Oltipraz on change in quantity of liver fat (% change) assessed by MRS from baseline to 24 weeks in patients.
7 secondary outcomes
change in liver fat concentration
Time frame: 24 weeks
change in BMI
Time frame: 8, 16, 24 weeks
change in NAFLD Fibrosis score (NFS)
Time frame: 24 weeks
change in ALT, AST, γ-GT
Time frame: 8, 16, 24 weeks
change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG)
Time frame: 8, 16, 24 weeks
change in HOMA-IR
Time frame: 8, 16, 24 weeks
change in waist circumference
Time frame: 24 weeks
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 30 Mar 2016.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oltipraz 1 (90mg) and Oltipraz 2 (120mg) in people with Non-alcholic Fatty Liver Disease, run by PharmaKing at 5 sites 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
MRS(magnetic resonance spectroscopy) (time frame: 24 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 30 Mar 2016.