A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis

Phase 3 Withdrawn Sagimet Biosciences Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression without the worsening of steatohepatitis.

Timeline

Start: 2025-03
Primary completion: 2030-12
Completion: 2030-12

Publications

Dembitz V, James SC, Gallipoli P. Targeting lipid metabolism in acute myeloid leukemia: biological insights and therapeutic opportunities. Leukemia. 2025 Aug;39(8):1814-1823. doi: 10.1038/s41375-025-02645-z. Epub 2025 May 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Denifanstat	Small molecule	25 mg	Oral
Subject	Denifanstat	Small molecule	50 mg	Oral

A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis

Summary

Timeline

Publications

Drugs

Indications