drugset / Trial / NCT03953456

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

NCT03953456

Phase 2 Terminated 17 enrolled Genfit
RandomizedCrossoverQuadruple-blindTreatment

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

Timeline

Start
2019-08-16
Primary completion
2020-03-11
Completion
2020-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Elafibranor Small molecule 120 mg Oral

Indications