Clinical Trial Details
| Trial ID: | L0074 |
| Source ID: | NCT03763877 |
| Associated Drug: | PXL770 |
| Title: | A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT03763877/results |
| Conditions: | Nonalcoholic Fatty Liver |
| Interventions: | Drug: PXL770|Drug: Placebo Oral Capsule |
| Outcome Measures: | Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)|Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)|Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)|Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])|Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment|Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment|Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment|Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment|Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment|Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment|Change in Total Cholesterol From Baseline to Week12/End of Treatment|Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment|Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment|Change in Triglycerides From Baseline to Week12/End of Treatment|Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment|Change in Body Weight From Baseline to Week 12/End of Treatment |
| Sponsor/Collaborators: | Poxel SA |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 121 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | March 29, 2019 |
| Completion Date: | August 10, 2020 |
| Results First Posted: | October 28, 2021 |
| Last Update Posted: | October 28, 2021 |
| Locations: | Study Site 02, Los Angeles, California, United States|Study Site 01, Gainesville, Florida, United States|Study Site 11, Ocoee, Florida, United States|Study Site 15, Orlando, Florida, United States|Study Site 10, Athens, Georgia, United States|Study Site 03, Indianapolis, Indiana, United States|Study Site 07, Marrero, Louisiana, United States|Study Site 05, West Monroe, Louisiana, United States|Study Site 08, Berlin, New Jersey, United States|Study Site 09, Durham, North Carolina, United States|Study Site 13, Rapid City, South Dakota, United States|Study Site 06, Arlington, Texas, United States|Study Site 04, San Antonio, Texas, United States|Study Site 12, San Antonio, Texas, United States|Study Site 14, Richmond, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT03763877 |
