NCT04142749

Oltipraz for Liver Fat Reduction in Patients With Non-alcoholic Fatty Liver Disease Except for Liver Cirrhosis

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Oltipraz

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: PharmaKing · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.

Detailed description

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	Oltipraz	Total 90mg, By mouth, TID
DRUG	Placebos	Total 90mg, By mouth, TID

Timeline

• Start date: 2019-11-15
• Primary completion: 2022-09-02
• Completion: 2022-09-26
• First posted: 2019-10-29
• Last updated: 2022-10-06

Locations

21 sites across 1 country: South Korea