Elafibranor in NASH and Fibrosis

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Confirmation of steatohepatitis on a diagnostic liver biopsy
  • Fibrosis Stage 1 or greater and below Stage 4 (according to the NASH Clinical Research Network fibrosis staging system)
  • Body mass index ≤45 kg/m²

Key Exclusion Criteria

  • Known heart failure
  • History of efficient bariatric surgery within five years before screening
  • Uncontrolled hypertension
  • Type 1 diabetes patients

Full Study Name

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis (GFT505-315-1) (IRB no. 45304)

Summary

This study focuses on patients diagnosed with nonalcoholic steatohepatitis (NASH) with fibrosis (recently confirmed by a liver biopsy) or those who are at high risk of having this disease and are willing to undergo a liver biopsy to determine whether they have NASH with fibrosis. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called elafibranor in these patients. Researchers will assess the efficacy of elafibranor compared to placebo (inactive substance) for the treatment of NASH. The study will also evaluate whether elafibranor reduces the number of patients that will develop further complications from NASH, such as liver cirrhosis.

Phase

Phase III


Principal Investigator

Mazen Noureddin, MD

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