drugset / Trial / NCT03953456
Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elafibranor | Small molecule | 120 mg | Oral |