Non-alcholic Fatty Liver Disease Clinical Trial
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
| Verified date | March 2016 |
| Source | PharmaKing |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | MFDS: Ministry of Food and Drug Safety(Korea) |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 283 |
| Est. completion date | March 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Daehak-ro Jongno-gu | Seoul |
| Korea, Republic of | Inje University Ilsan Paik Hospital | Dahwa-dong, Ilsanseo-gu, Goyang-si | Gyeonggi-do |
| Korea, Republic of | Korea University Guro hospital | Gurodong-ro | Seoul |
| Korea, Republic of | NHUS Ilsan Hospital | Ilsan-ro Ilsan-donggu | Goyang-si |
| Korea, Republic of | Boramae Hospital | Sindaebang-dong Dongjak-gu | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| PharmaKing |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | change in Adipokine, CK-18 | 8, 16, 24 weeks | No | |
| Primary | 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. | 24 weeks | No |
| Secondary | change in liver fat concentration | 24 weeks | No | |
| Secondary | change in BMI | 8, 16, 24 weeks | No | |
| Secondary | change in NAFLD Fibrosis score (NFS) | 24 weeks | No | |
| Secondary | change in ALT, AST, ?-GT | 8, 16, 24 weeks | No | |
| Secondary | change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG) | 8, 16, 24 weeks | No | |
| Secondary | change in HOMA-IR | 8, 16, 24 weeks | No | |
| Secondary | change in waist circumference | 24 weeks | No |