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A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

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Trial Profile

A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Feb 2025

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At a glance

  • Drugs Empagliflozin (Primary) ; Lanifibranor (Primary)
  • Indications Non-alcoholic steatohepatitis; Type 2 diabetes mellitus
  • Focus Proof of concept; Therapeutic Use
  • Acronyms LEGEND
  • Sponsors Inventiva Pharma

Most Recent Events

  • 29 Jan 2025 According to an Inventiva Pharma media release, the results of this study has been published in the Journal of Hepatology.
  • 22 Jan 2025 Results presented in the Inventiva Media Release.
  • 22 Jan 2025 According to an Inventiva Pharma media release, the results of this study has been selected to be presented by co-Principal Investigator of LEGEND study Dr. Onno Holleboom in an oral plenary presentation at the upcoming Steatotic Liver Disease (SLD) Summit 2025 hosted by the European Association for the Study of the Liver (EASL) on January 23-25 in Estoril, Portugal.

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