NCT03953456

Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)

A Double-Blind, Placebo-Controlled, Cross-over Phase II Study to Evaluate the Effect of a 6-week Elafibranor (120mg) Treatment Administered Once Daily on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, cross-over (placebo or elafibranor \[GFT505\]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an adult NAFL population after 6 weeks of treatment with a 4-week wash-out period. This study will achieve mechanistic information about the mode of action of Elafibranor on the (lipid) metabolism in the human fatty liver

Conditions

• Non-Alcoholic Fatty Liver

Interventions

Type	Name	Description
DRUG	elafibranor 120mg	elafibranor 120mg is a coated tablet for oral administration, once daily
DRUG	Placebo	Placebo is a coated tablet for oral administration, once daily

Timeline

• Start date: 2019-08-16
• Primary completion: 2020-03-11
• Completion: 2020-07-14
• First posted: 2019-05-16
• Last updated: 2020-08-31

Locations

1 site across 1 country: Netherlands