Overview

A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease

Status:
Not yet recruiting
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
Summary
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3 study, in which participants will be randomized to venglustat versus standard of care therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of venglustat on left ventricular mass index (LVMI) in adult participants with Fabry disease and left ventricular hypertrophy. - Study visits will take place approximately every 3 to 6 months - Participants who complete the randomized period may continue to the open-label extension (OLE) to receive venglustat for up to an additional 18 months.
Phase:
Phase 3
Details
Lead Sponsor:
Genzyme, a Sanofi Company