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Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT02068339•PharmaKing

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 75 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (5)

NHUS Ilsan Hospital

Ilsan-ro Ilsan-donggu, Goyang-si, South Korea

Inje University Ilsan Paik Hospital

Dahwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Daehak-ro Jongno-gu, Seoul, South Korea

Korea University Guro hospital

Gurodong-ro, Seoul, South Korea

Boramae Hospital

Sindaebang-dong Dongjak-gu, Seoul, South Korea

Key Dates

Start Date

February 1, 2014

Primary Completion Date

February 1, 2016

Completion Date

March 1, 2016

Last Updated

March 30, 2016

Enrollment

283

ACTUAL participants

Conditions

Non-alcholic Fatty Liver Disease

Interventions

Oltipraz 1 (90mg)

DRUG

Placebo

DRUG

Oltipraz 2 (120mg)

DRUG