Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
- Conditions
- Non-alcholic Fatty Liver Disease
- Interventions
- Registration Number
- NCT02068339
- Lead Sponsor
- PharmaKing
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Comparator / Tid (total 0mg) Oltipraz 1 Oltipraz 1 (90mg) Total 90mg, by mouth, tid Oltipraz 2 Oltipraz 2 (120mg) Total 120mg, by mouth, tid
- Primary Outcome Measures
Name Time Method MRS(magnetic resonance spectroscopy) 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.
- Secondary Outcome Measures
Name Time Method change in liver fat concentration 24 weeks change in BMI 8, 16, 24 weeks change in NAFLD Fibrosis score (NFS) 24 weeks change in ALT, AST, γ-GT 8, 16, 24 weeks change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG) 8, 16, 24 weeks change in HOMA-IR 8, 16, 24 weeks change in waist circumference 24 weeks
Trial Locations
- Locations (5)
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
Seoul National University Hospital
🇰🇷Daehak-ro Jongno-gu, Seoul, Korea, Republic of
NHUS Ilsan Hospital
🇰🇷Ilsan-ro Ilsan-donggu, Goyang-si, Korea, Republic of
Boramae Hospital
🇰🇷Sindaebang-dong Dongjak-gu, Seoul, Korea, Republic of