clinical trial · NCT06594523
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
MASHNASHMetabolic Dysfunction-associated SteatohepatitisNoncirrhotic Metabolic Dysfunction-associated SteatohepatitisNonalcoholic SteatohepatitisNonalcoholic Fatty LiverDenifanstatPlacebo
brief 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.
started
Mar 1, 2025
primary completion
Dec 1, 2030
completion
Dec 1, 2030
last updated
May 15, 2025
detailed description
Approximately 1260 patients (including at least 60% of F3 patients) will be enrolled to receive either denifanstat 50 mg (580 patients), placebo (580 patients), or denifanstat 25 mg (100 patients).
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol