clinical trial · NCT06692283
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH
MASLDMASHNASHMetabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Dysfunction-Associated SteatohepatitisNonalcoholic SteatohepatitisNonalcoholic Fatty LiverdenifanstatPlacebo
brief summary
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.
started
Mar 1, 2025
primary completion
Jun 1, 2026
completion
Jun 1, 2027
last updated
May 15, 2025
detailed description
Up to 2000 patients will be randomized to receive either denifanstat 50 mg or placebo.
official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol