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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

Primary Purpose

Non-alcholic Fatty Liver Disease

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Oltipraz 1 (90mg)

Placebo

Oltipraz 2 (120mg)

About this trial

This is an interventional treatment trial for Non-alcholic Fatty Liver Disease

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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
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

Sites / Locations

NHUS Ilsan Hospital
Inje University Ilsan Paik Hospital
Seoul National University Hospital
Korea University Guro hospital
Boramae Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Oltipraz 1

Oltipraz 2

Arm Description

Placebo Comparator / Tid (total 0mg)

Total 90mg, by mouth, tid

Total 120mg, by mouth, tid

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change in liver fat concentration

change in BMI

change in NAFLD Fibrosis score (NFS)

change in ALT, AST, γ-GT

change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG)

change in HOMA-IR

change in waist circumference

Full Information

NCT ID

NCT02068339

First Posted

February 19, 2014

Last Updated

March 29, 2016

Sponsor

PharmaKing

1. Study Identification

Unique Protocol Identification Number

NCT02068339

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PharmaKing

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-alcholic Fatty Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

283 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Comparator / Tid (total 0mg)

Arm Title

Oltipraz 1

Arm Type

Experimental

Arm Description

Total 90mg, by mouth, tid

Arm Title

Oltipraz 2

Arm Type

Experimental

Arm Description

Total 120mg, by mouth, tid

Intervention Type

Drug

Intervention Name(s)

Oltipraz 1 (90mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Oltipraz 2 (120mg)

Primary Outcome Measure Information:

Title

MRS(magnetic resonance spectroscopy)

Description

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.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

change in liver fat concentration

Time Frame

24 weeks

Title

change in BMI

Time Frame

8, 16, 24 weeks

Title

change in NAFLD Fibrosis score (NFS)

Time Frame

24 weeks

Title

change in ALT, AST, γ-GT

Time Frame

8, 16, 24 weeks

Title

change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG)

Time Frame

8, 16, 24 weeks

Title

change in HOMA-IR

Time Frame

8, 16, 24 weeks

Title

change in waist circumference

Time Frame

24 weeks

Other Pre-specified Outcome Measures:

Title

change in Adipokine, CK-18

Time Frame

8, 16, 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

NHUS Ilsan Hospital

City

Ilsan-ro Ilsan-donggu

State/Province

Goyang-si

ZIP/Postal Code

410-719

Country

Korea, Republic of

Facility Name

Inje University Ilsan Paik Hospital

City

Dahwa-dong, Ilsanseo-gu, Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

411-706

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Daehak-ro Jongno-gu

State/Province

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Korea University Guro hospital

City

Gurodong-ro

State/Province

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Boramae Hospital

City

Sindaebang-dong Dongjak-gu

State/Province

Seoul

ZIP/Postal Code

156-707

Country

Korea, Republic of

12. IPD Sharing Statement

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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

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