Trial · NCT05280548
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease
NCT05280548, Phase 3, Active not recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease. Trials, record NCT05280548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05280548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease
- NCT number
- NCT05280548
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 104 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Fabry Disease
- Interventions
- Venglustat (GZ402671), Agalsidase alfa, Agalsidase beta (GZ419828), Migalastat
- First posted
- 2022-03-15
- Last updated
- 2026-06-24
- Other registries' IDs
- eudract:2021-002320-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Slope of left ventricular mass index as measured by cardiac magnetic resonance imaging (MRI) (central reading) | from baseline to 18 months | |
| Secondary | Slope of estimated glomerular filtration rate (eGFR) as assessed by the chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation | from baseline to 18 months | |
| Secondary | Change in T1 relaxation time, measured by cardiac MRI (central reading) | from baseline to 18 months | |
| Secondary | Change in global longitudinal strain, measured by echocardiography (central reading) | from baseline to 18 months | |
| Secondary | Percent Change in tiredness component of FD-PRO | from baseline to 18 months | |
| Secondary | Percent Change in swelling in lower extremities component of FD-PRO | from baseline to 18 months | |
| Secondary | Number of participants with adverse event (AE) and serious adverse event (SAE) | from baseline to 18 months | |
| Secondary | Change in Beck Depression Inventory-II (BDI-II) score | from baseline to 18 months | |
| Secondary | Change in the lens clarity by ophthalmological examination | from baseline to 18 months | |
| Secondary | Plasma venglustat concentrations at prespecified visits over the study duration | from baseline to 18 months |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05280548
GET https://conductscience.org/api/trials/v1/NCT05280548/registered