NCT02068339

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: PharmaKing · Industry
• Sex: All
• Age: 19 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-alcholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Oltipraz 1 (90mg)
DRUG	Placebo
DRUG	Oltipraz 2 (120mg)

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2014-02-21
• Last updated: 2016-03-30

Locations

5 sites across 1 country: South Korea