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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2023

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At a glance

  • Drugs Selonsertib (Primary)
  • Indications Hepatic fibrosis; Liver cirrhosis; Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms STELLAR-3
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 24 Jun 2023 Results assessing the associations between use ofantidiabetic or lipid-lowering drugs and blood liver fibrosis biomarkers from two phase III trials of NASH patients with bridging fibrosis (NCT03053050, N=785) or compensated cirrhosis(NCT03053063, N=864), presented at the European Association for the Study of the Liver Congress 2023.
    • 26 Jun 2022 Results of a pooled analysis of data from STELLAR 3 and STELLAR 4 studies of liver biopsy images, and used it to identify baseline gene signatures that are predictive of fibrosis progression or regression in NASH with the help of machine learning, presented at The International Liver Congress 2022
    • 26 Jun 2022 Results from NCT03053050 and NCT03053063 studies assessing the prognostic utility of machine learning-facilitated continuous scoring of histologic features presented at The International Liver Congress 2022

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