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OpenTrials
Completed

NCT Number: NCT02068339

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

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.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oltipraz 1 (90mg)

Drug

Placebo

Drug

Oltipraz 2 (120mg)

Drug

Primary outcomes

  1. MRS(magnetic resonance spectroscopy)

    Time frame: 24 weeks

    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 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

Sponsors and collaborators

Lead sponsor

PharmaKing

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 21, 2014
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.