| Trial ID: | L0149 |
| Source ID: | NCT03437720
|
| Associated Drug: |
SAR??425899.00
|
| Title: |
Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease
|
| Acronym: |
Restore
|
| Status: |
Withdrawn
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis|Type 2 Diabetes Mellitus
|
| Interventions: |
Drug: SAR425899|Drug: Placebo
|
| Outcome Measures: |
Resolution of Non-alcoholic steatohepatitis (NASH)|No hepatocyte ballooning, lobular inflammation score 0 or 1, without worsening of fibrosis|Change in overall NAFLD activity score (NAS)|Change in NAS individual components|Change in fibrosis score|Major adverse cardiac events|Change in Magnetic Resonance Imaging-determined Proton Density Fat Fraction (MRI-PDFF)|Improvement of fibrosis without worsening of hepatocyte ballooning component of NAS|Change in body weight|Change in waist circumference|Change in hip circumference|Change in waist to hip ratio|Assessment of pharmacokinetic (PK) parameter: AUC0-24|Assessment of PK parameter: Cmax|Assessment of PK parameter: Ctrough
|
| Sponsor/Collaborators: |
Sanofi
|
| Gender: |
All
|
| Age: |
18 Years to 80 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
0
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
May 23, 2019
|
| Completion Date: |
August 25, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
April 8, 2019
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT03437720
|
