| Trial ID: | L0002 |
| Source ID: | NCT03953456
|
| Associated Drug: |
Elafibranor
|
| Title: |
Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
|
| Acronym: |
--
|
| Status: |
Terminated
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver
|
| Interventions: |
Drug: elafibranor 120mg|Drug: Placebo
|
| Outcome Measures: |
Change in relative amount of saturated fatty acids in the liver|Change in hepatic insulin sensitivity|Glucose homeostasis markers|Lipid metabolism markers|Inflammatory markers|Liver function|Renal function|Body weight|Body Mass Index|Waist circumference|Incidence and severity of treatment emergent adverse events (TEAEs) and their relationship to study drug|Incidence of clinically meaningful changes from baseline in safety laboratory parameters, and vital signs
|
| Sponsor/Collaborators: |
Genfit
|
| Gender: |
All
|
| Age: |
40 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
17
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
August 16, 2019
|
| Completion Date: |
July 14, 2020
|
| Results First Posted: |
--
|
| Last Update Posted: |
August 31, 2020
|
| Locations: |
NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, Netherlands
|
| URL: |
https://ClinicalTrials.gov/show/NCT03953456
|
