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
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.
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 →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.
Exclusion Criteria:
Placebo Comparator / Tid (total 0mg)
Drug: Placebo
Total 90mg, by mouth, tid
Drug: Oltipraz 1 (90mg)
Total 120mg, by mouth, tid
Drug: Oltipraz 2 (120mg)
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
change in liver fat concentration
Time frame: 24 weeks
change in BMI
Time frame: 8, 16, 24 weeks
change in NAFLD Fibrosis score (NFS)
Time frame: 24 weeks
change in ALT, AST, γ-GT
Time frame: 8, 16, 24 weeks
change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG)
Time frame: 8, 16, 24 weeks
change in HOMA-IR
Time frame: 8, 16, 24 weeks
change in waist circumference
Time frame: 24 weeks
change in Adipokine, CK-18
Time frame: 8, 16, 24 weeks
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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