A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease

Inclusion Criteria:

• Male and female adult patients 16 year of age or older, who have had a previouslyconfirmed diagnosis of Fabry disease and a history of clinical symptoms of Fabrydisease

• Patients who are treatment-naïve or without prior treatment with an approved orexperimental therapy for Fabry disease within at least 6 months prior to screening.

• Average score of ≥3 (0=no symptom, 10=symptom as bad as you can imagine) on theparticipant-defined most-bothersome symptom (among neuropathic pain in upperextremities, neuropathic pain in lower extremities, or abdominal pain), as measuredby the Fabry Disease Patient-Reported Outcome (FD-PRO) at screening.

• Contraception (with double contraception methods) for male and female participants;not pregnant or breastfeeding for female participants; no sperm donation for maleparticipants.

• Weight ≥30 Kg

• A signed informed consent must be provided prior to any study-related procedures.

Exclusion Criteria:

• Any manifestations of Fabry disease that preclude placebo administration.

• History of transient ischemic attack, stroke, myocardial infarction, heart failure,evidence of left ventricular hypertrophy and/or cardiac fibrosis, majorcardiovascular surgery, or kidney transplantation.

• History of clinically significant cardiac arrhythmia. Atrial fibrillation that iswell controlled on a stable medical regimen for at least 12 months is not anexclusion if the CHA2DS2-VASc score is 0 for males or 1 for females.

• Patients with hepatitis C, HIV, or hepatitis B infection.

• Neuropathic pain in upper or lower extremities, or abdominal pain not related toFabry disease.

• History of seizures currently requiring treatment.

• Uncontrolled hypertension over the past 12 months prior to screening, or systolic BP >=150 or diastolic BP >=100 at screening.

• Estimated glomerular filtration rate <60 mL/min/1.73m².

• Urine protein to creatinine ratio >= 1 g/g at screening.

• Presence of severe depression as measured by Beck's Depression Inventory (BDI)-II >28 and/or a history of an untreated, unstable major affective disorder within 1year of the screening visit.

• Positive SARS-CoV-2 virus test within 2 weeks of enrollment, or COVID 19 requiringhospitalization within 6 months of enrollment.

• Moderate to severe hepatic impairment.

• History of drug and/or alcohol abuse.

• History of or active hepatobiliary disease.

• Liver enzymes (alanine aminotransferase (ALT)/aspartate aminotransferase (AST)) ortotal bilirubin >2 times the upper limit of normal (ULN).

• Initiation of chronic treatment for pain, or change in pain medication regimen,within 3 months prior to randomization.

• Strong or moderate inducers or inhibitors of cytochrome P450 3A within 14 days or 5half-lives, whichever is longer, prior to randomization.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.