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A Phase 2B, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (FASCINATE-2)

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Trial Profile

A Phase 2B, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (FASCINATE-2)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Oct 2024

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At a glance

  • Drugs Denifanstat (Primary)
  • Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms FASCINATE-2
  • Sponsors Sagimet Biosciences

    • Most Recent Events

    • 01 Oct 2024 According to a Sagimet Biosciences media release, the Company announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to denifanstat for treatment of noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This designation is supported by data from this study.
    • 14 Aug 2024 According to a Sagimet Biosciences media release, Rohit Loomba is the Principal Investigator of the Phase 2b FASCINATE-2 clinical trial.
    • 10 Jun 2024 According to a Sagimet Biosciences media release, the company will host a conference call and webcast on Thursday, June 13, 2024 to discuss data form this trial.

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