Efficacy and Safety of Oltipraz in the Patients With Non-alcoholic Fatty Liver Disease (PMK-N01GI1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaKing
ClinicalTrials.gov Identifier:
NCT01373554
First received: June 3, 2011
Last updated: December 8, 2013
Last verified: December 2013

June 3, 2011
December 8, 2013
May 2011
June 2013   (final data collection date for primary outcome measure)
MRS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of the Oltipraz on change in quantity of liver fat concentration assessed by MRS from baseline to 24 weeks in patients with non-alcoholic fatty liver disease
Same as current
Complete list of historical versions of study NCT01373554 on ClinicalTrials.gov Archive Site
  • change in ALT, AST and total bilirubin [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change in Cholesterol, Triglyceride [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change in HOMA-IR [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change in BMI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • changes in NAS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Subjects with liver biopsy:
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Oltipraz in the Patients With Non-alcoholic Fatty Liver Disease
A Multicenter, Randomized, Double-blind, Placebo-controlled, A Multicenter, Randomized, Double-blind, Placebo-controlled, 3 Parallel Groups, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Oltipraz in Patients With Non-alcoholic Fatty Liver Disease (Except 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-alcoholic Fatty Liver Disease
  • Drug: Placebo
    30mig/bid or 60mg/bid P.O
  • Drug: Oltipraz
    30mig/bid or 60mg/bid P.O
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Oltipraz
    Intervention: Drug: Oltipraz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 18, under 75 years of age
  • Patients with non-alcoholic fatty liver disease

Exclusion Criteria:

  • Over 2 ratio of AST to ALT
  • Type 1 diabetes mellitus (insulin-dependent diabetes mellitus)
  • Disorder in liver function with an exception of non-alcoholic fatty liver (e.g. Virus infection, biliary atresia, autoimmune hepatitis and etc.)
  • Patients who have been taken drugs induced fatty liver for over 3 month within 1 year of participation in this study; amiodarone, tamoxifen, methotrexate, tetracyclines, glucocorticoids, anabolic steroids, over usual dose of estrogen for hormone replacement therapy and valproate
  • Patients who has been taken any medications that could affect the treatment for non-alcoholic steatohepatitis: insulin, insulin sensitizer(metformin, thiazolidinedione), high dose of vitamin E, high dose of UDCA, pentoxifylline, SAM-e, Betaine, types of Statin, types of fibrate and orlistat
  • 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; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
  • Any history of immune disorder which affect the changes in cytokine:

inflammatory bowel disease, autoimmune thrombocytopenic purpura, system lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatic arthritis and etc

  • 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
  • Patient who considered ineligible for participation in the study as Investigator's judgment
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01373554
PMK-N01GI1
Yes
PharmaKing
PharmaKing
Not Provided
Principal Investigator: YoonJun Kim, MD.PhD Seoul National University Hospital
PharmaKing
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP