Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaKing
• Treatments: Oltipraz

Criteria

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