Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease
Status:
Withdrawn
Trial end date:
2021-08-25
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To evaluate the dose response relationship of SAR425899 compared to placebo on resolution
of non-alcoholic steatohepatitis (NASH) with no worsening of fibrosis in diabetic and
non-diabetic patients with histopathologically-confirmed NASH.
Secondary Objectives:
- To assess the effect of SAR425899 on overall non-alcoholic fatty liver disease (NAFLD)
activity score (NAS), individual components of NAS (steatosis, hepatocyte ballooning,
and lobular inflammation), and fibrosis score.
- To assess to the effect of SAR425899 on MRI-PDFF (Magnetic Resonance Imaging-determined
Proton Density Fat Fraction) derived parameters (total liver fat, liver volume, and
fractional liver fat content).
- To assess the effect of SAR425889 on body weight and waist/hip circumference ratio.
- To assess SAR425899 pharmacokinetics.
- To assess safety and tolerability of SAR425899.