A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
104actual
Sites
54
Countries
Austria, Canada, China +16
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-05-03 | actual | When the study began enrolling |
| Primary completion | 2026-05-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-06 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Fabry Disease
Interventions
- Drug: Venglustat (GZ402671)
- Drug: Agalsidase alfa — also filed as Replagal®
- Drug: Agalsidase beta (GZ419828) — also filed as Fabrazyme®
- Drug: Migalastat — also filed as Galafold®
Primary outcome
what the primary-completion date above is the date OFSlope of left ventricular mass index as measured by cardiac magnetic resonance imaging (MRI) (central reading)
measured from baseline to 18 months
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