| Outcome Measures: |
Primary: Resolution of Non-alcoholic steatohepatitis (NASH), Percentage of participants with absence of hepatocyte ballooning (NAFLD - non-alcoholic fatty liver disease - activity score, NAS = 0) without worsening of fibrosis score at week 52. -, Week 52 | Secondary: No hepatocyte ballooning, lobular inflammation score 0 or 1, without worsening of fibrosis, Percentage of participants with absence of hepatocyte ballooning (NAS = 0), lobular inflammation NAS = 0 or 1, without worsening of fibrosis score at week 52., Week 52|Change in overall NAFLD activity score (NAS), Change from baseline to week 52 in overall NAFLD activity score (NAS)., Baseline to week 52|Change in NAS individual components, Change from baseline to week 52 in individual components of NAS (steatosis)., Baseline to week 52|Change in NAS individual components, Change from baseline to week 52 in individual components of NAS (hepatocyte ballooning)., Baseline to week 52|Change in NAS individual components, Change from baseline to week 52 in individual components of NAS (lobular inflammation)., Baseline to week 52|Change in fibrosis score, Change from baseline to week 52 in fibrosis score., Baseline to week 52|Major adverse cardiac events, Number of patients with major cardiac events, Baseline to week 52|Change in Magnetic Resonance Imaging-determined Proton Density Fat Fraction (MRI-PDFF), Change from baseline to week 26 and to week 52 in MRI-PDFF-derived total liver fat, liver volume and fractional liver fat content., Baseline to week 26 and week 52|Improvement of fibrosis without worsening of hepatocyte ballooning component of NAS, Percentage of participants with improvement of fibrosis by at least 1 stage without worsening of hepatocyte ballooning component of NAS at week 52, Week 52|Change in body weight, Change from baseline to week 52 in body weight, Baseline to week 52|Change in waist circumference, Change from baseline to week 52 in waist circumference, Baseline to week 52|Change in hip circumference, Change from baseline to week 52 in hip circumference, Baseline to week 52|Change in waist to hip ratio, Change from baseline to week 52 in waist to hip ratio, Baseline to week 52|Assessment of pharmacokinetic (PK) parameter: AUC0-24, Area under the concentration-time curve from 0 to 24 hours (AUC0-24), Week 52|Assessment of PK parameter: Cmax, Observed maximum plasma concentration after administration (Cmax), Week 52|Assessment of PK parameter: Ctrough, Plasma concentration immediately prior to treatment administration during repeat dosing levels (Ctrough), Baseline to week 52
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