Sanofi registers three-country OPTIMUS RISK cardiovascular cohort studies in ASCVD patients

Sanofi's registry activity for the week is led by three newly posted observational cardiovascular studies, alongside updates to previously listed trials in respiratory, neurology, and hematology.

• OPTIMUS RISK - Italy (NCT07906132) is a completed retrospective cohort study that evaluates cardiovascular outcomes among individuals with clinically established atherosclerotic cardiovascular disease who have not previously experienced a myocardial infarction or ischemic stroke.¹ The Italy cohort had an actual enrollment of 93,000 participants¹, with study completion dated October 18, 2026.
• OPTIMUS RISK - Netherlands (NCT07905508) is also completed, using the same design to study ASCVD patients without prior ischemic events. The Netherlands cohort had an actual enrollment of 180,000 participants², with study completion on June 30, 2026.
• OPTIMUS RISK - Spain (NCT07905534) is active, not recruiting, with an actual enrollment of 18,000 participants³ and an estimated study completion of November 24, 2026.
• ENSEMBLE (NCT06914908), a Phase 2 single-arm extension study of lunsekimig in adult participants with chronic rhinosinusitis with nasal polyps, remains active, not recruiting. The study enrolled 71 participants⁴ who will be followed for up to approximately 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up⁴, with primary completion estimated for February 22, 2029.
• ORION (NCT07898371) remains recruiting. The observational study tracks real-world treatment patterns, data from patient reported outcomes, the effectiveness profile of tolebrutinib, and health care utilization data in routine practice⁵ among multiple sclerosis patients, with an estimated enrollment of 3,000 participants and primary completion estimated for September 21, 2031.
• PREFER (NCT07895381) remains not yet recruiting. The study is designed to gather patient-reported outcomes via online surveys, qualitative interviews conducted via teleconference, and electronic medical record review to describe real-world patient experiences, treatment satisfaction, adherence, and clinical management of fitusiran⁶ in adolescents and adults with hemophilia A or B, with an estimated enrollment of 100 participants.