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REGN7508 and REGN9933 for Peripheral Artery Disease

This study is looking into two experimental drugs, REGN7508 and REGN9933, for people with Peripheral Artery Disease (PAD). PAD means the blood vessels in your arms and legs are narrowed. If you have PAD and recently had a procedure to improve blood flow in your legs (Lower Extremity Revascularization or LER), you have a higher risk of blood clots. This study aims to see how well REGN7508 and REGN9933 prevent serious blood clots. The effects of these drugs will be compared to rivaroxaban, another medication, and a placebo (an inactive substance). The study will track how long it takes for participants to experience a major blood clot event or significant bleeding, for up to 42 months.

Study design
This is an interventional study with a planned enrollment of 7050 participants. It compares REGN7508, REGN9933, rivaroxaban, and a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 42 months to monitor for major blood clot events or significant bleeding.

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NCT07318610

Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease

Recruiting
PHASE3Ages 18+InterventionalTreatment
Regeneron Pharmaceuticals
~7,050 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:REGN7508REGN9933PlaceboRivaroxaban

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death
Measured over Approximately up to 42 months
+1 more outcome measured

Conditions

Peripheral Artery Disease (PAD)

Explore related trials

Peripheral Artery DiseaseCoagulation Factor XI

Where it's being run

17 sites across 11 states
Texas4
Tennessee3
California2
Alabama1
Arizona1
Arkansas1
Florida1
Indiana1

Study leadership

  • Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals

Who to contact

Clinical Trials Administrator
[email protected]
844-734-6643
Email the study team

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What this trial measures

  • Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) deathApproximately up to 42 months

    Cohort 1

  • Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleedingApproximately up to 42 months

    Cohort 1 and 2