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

NCT ID: NCT02068339

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 283 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-03-31

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.

Conditions

Non-alcholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo Comparator / Tid (total 0mg)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oltipraz 1

Total 90mg, by mouth, tid

Group Type: EXPERIMENTAL

Oltipraz 1 (90mg)

Intervention Type: DRUG

Oltipraz 2

Total 120mg, by mouth, tid

Group Type: EXPERIMENTAL

Oltipraz 2 (120mg)

Intervention Type: DRUG

Interventions

Oltipraz 1 (90mg)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Oltipraz 2 (120mg)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaKing

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

South Korea

Other Identifiers

PMK-N01GI1_Phase 3

Identifier Type: -

Identifier Source: org_study_id