Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis (MASH) and F2/F3 Fibrosis (FASCINATE-3)

Status: Withdrawn prior to enrolment

Phase of Trial: Phase III

Latest Information Update: 23 May 2025

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At a glance

15 May 2025 Status changed from not yet recruiting to withdrawn prior to enrolment due to business decision.
12 Mar 2025 According to a Sagimet Biosciences media release, one of the primary end-points in this study is liver biopsy assessments at 52 weeks, by when Sagimet plans to seek accelerated approval in the US and Europe based on this 52-week data.
29 Jan 2025 Planned initiation date changed from 1 Dec 2024 to 1 Mar 2025.

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