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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)

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: 16 May 2025

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At a glance

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

Most Recent Events

  • 09 May 2025 Primary endpoint related to safety has been cancelled. Timeframe for both the efficacy endpoints has been updated to 52 weeks.
  • 23 Apr 2025 According to a Sagimet Biosciences media release, company will present data from this study in multiple poster presentation at the European Association for the Study of Liver (EASL) Congress 2025 being held May 7-10, 2025 in Amsterdam, Netherlands.
  • 12 Mar 2025 According to a Sagimet Biosciences media release, the company presented clinical denifanstat and preclinical FASN inhibitor data at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting 2024, through an oral and a poster presentation in November 2024.

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