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CompletedNCT02068339Updated Mar 30, 2016

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

A Phase 3 interventional study of Oltipraz 1 (90mg) and Placebo in Non-alcholic Fatty Liver Disease, sponsored by PharmaKing. Completed at 5 sites in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-30.

Sponsored by PharmaKing · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
283
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Liver Diseases

2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.

This study's enrollment of 283 is above the median of 50 across 1,322 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

PharmaKing is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
283 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo Comparator / Tid (total 0mg)

    Drug: Placebo

  • Experimental
    Oltipraz 1

    Total 90mg, by mouth, tid

    Drug: Oltipraz 1 (90mg)

  • Experimental
    Oltipraz 2

    Total 120mg, by mouth, tid

    Drug: Oltipraz 2 (120mg)

Interventions

  • DrugOltipraz 1 (90mg)
  • DrugPlacebo
  • DrugOltipraz 2 (120mg)
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 weeks

Secondary outcomes

  1. change in liver fat concentration

    Time frame: 24 weeks

  2. change in BMI

    Time frame: 8, 16, 24 weeks

  3. change in NAFLD Fibrosis score (NFS)

    Time frame: 24 weeks

  4. change in ALT, AST, γ-GT

    Time frame: 8, 16, 24 weeks

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

    Time frame: 8, 16, 24 weeks

  6. change in HOMA-IR

    Time frame: 8, 16, 24 weeks

  7. change in waist circumference

    Time frame: 24 weeks

Other outcomes

  1. change in Adipokine, CK-18

    Time frame: 8, 16, 24 weeks

07

Study locations

5 sites
  • NHUS Ilsan Hospital
    Ilsan-ro Ilsan-donggu, Goyang-si 410-719, Korea, Republic of
  • Inje University Ilsan Paik Hospital
    Dahwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do 411-706, Korea, Republic of
  • Seoul National University Hospital
    Daehak-ro Jongno-gu, Seoul 110-744, Korea, Republic of
  • Korea University Guro hospital
    Gurodong-ro, Seoul 152-703, Korea, Republic of
  • Boramae Hospital
    Sindaebang-dong Dongjak-gu, Seoul 156-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02068339
Lead sponsor
PharmaKing
Responsible party
Sponsor
First posted
Feb 21, 2014
Start date
Feb 2014
Primary completion
Feb 2016
Completion
Mar 2016
Last update
Mar 30, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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