NCT03437720

Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease

A 52-week Double-blind, Randomized, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of SAR425899 for the Treatment of Non-alcoholic Steatohepatitis (NASH)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study duration per participant will be approximately 64 weeks, consisting of up to 8 weeks screening plus 52 weeks treatment and 4 weeks post treatment follow-up.

Conditions

• Non-alcoholic Steatohepatitis
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SAR425899	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
DRUG	Placebo	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Timeline

• Start date: 2019-05-23
• Primary completion: 2021-08-25
• Completion: 2021-08-25
• First posted: 2018-02-19
• Last updated: 2022-04-13

Regulatory

• FDA-regulated drug study