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A phase III trial of Tesamorelin for the treatment of Non-alcoholic steatohepatitis (NASH) in the general population including HIV cohort

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A phase III trial of Tesamorelin for the treatment of Non-alcoholic steatohepatitis (NASH) in the general population including HIV cohort

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2025

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At a glance

  • Drugs Tesamorelin (Primary)
  • Indications Fibrosis; Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Theratechnologies

    • Most Recent Events

    • 08 Apr 2025 According to a Theratechnologies media release, the U.S. Food and Drug Administration (FDA) has approved the Company's Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV (tesamorelin for injection).
    • 09 Oct 2024 According to Thera Technologies media release, impact of Tesamorelin on cardiovascular disease risk prediction scores in Phase 3 Studies treatment arms: Subanalysis, will be presented in a poster session at IDWeek 2024, on Thursday, October 17, 2024, 12:15 PM -1:30 PM PT.
    • 15 Jul 2021 According to a Theratechnologies media release, this trial will include a futility analysis that will be performed after approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy.

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