NCT01373554

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: PharmaKing · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Placebo	30mig/bid or 60mg/bid P.O
DRUG	Oltipraz	30mig/bid or 60mg/bid P.O

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-06-01
• Completion: 2013-10-01
• First posted: 2011-06-15
• Last updated: 2013-12-10

Locations

5 sites across 1 country: South Korea