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A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

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Trial Profile

A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Apr 2024

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At a glance

  • Drugs Lanifibranor (Primary)
  • Indications Fibrosis; Non-alcoholic steatohepatitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms NATiV3; NATIVE3
  • Sponsors Inventiva Pharma

    • Most Recent Events

    • 27 Mar 2024 According to an Inventiva Pharma media release, despite the previously disclosed treatment-related Suspected Unexpected Serious Adverse Reaction (SUSAR) in a patient enrolled in the trial reported in the first quarter of 2024, the company already begun to resume screening and randomization in the U.S. sites operating under central IRB.
    • 07 Mar 2024 According to an Inventiva Pharma media release, Prior to the voluntary pause, 913 patients were already randomized in the NATiV3 clinical trial including 731 in the main cohort and over 550 patients were in screening. Inventiva anticipates the last patient first visit for the NATiV3 clinical trial in the first half of 2024.
    • 07 Mar 2024 According to an Inventiva Pharma media release, Screening of patients is resuming in sites operating under central IRB in the US. Other sites and countries are expected to resume screening and randomization activities progressively over the next weeks.
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