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New antibody drugs aim to prevent deadly clots in PAD patients after leg surgery

NCT ID NCT07318610

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 7 times

Summary

This phase 3 trial is testing two experimental drugs, REGN7508 and REGN9933, to prevent serious blood clots in people with peripheral artery disease who recently had leg surgery to improve blood flow. The study will enroll about 7,050 participants and compare the drugs to a placebo and the standard blood thinner rivaroxaban. The goal is to see if these antibodies can reduce the risk of life-threatening events like limb loss, heart attack, or stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
REGN7508 (cenvacibart) and REGN9933 (amrecibart), monoclonal antibodies targeting factor XI
What this could lead to
If successful, these drugs could offer a new way to prevent life-threatening blood clots in people with peripheral artery disease after leg surgery, potentially with fewer bleeding risks than current treatments.
What could go wrong
This is a large phase 3 trial, but the drugs are still experimental. They may not work better than existing options, and side effects or unexpected bleeding risks could emerge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 7,050 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol 2. At least 1 of the following enrichment factors for major thrombotic vascular events: 1. Bypass with prosthetic graft 2. Endovascular treatment with stenting 3. Target lesion length \>15 cm 4. History of LER or amputation for PAD prior to qualifying LER 5. Type 2 diabetes mellitus requiring pharmacologic treatment 6. Comorbid symptomatic coronary artery disease as described in the protocol 7. Chronic kidney disease as described in the protocol 8. Age ≥75 years Key Exclusion Criteria: 1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome 2. Has known bleeding diathesis, platelet count \<50,000/mm\^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations 3. Has recent coronary revascularization as described in the protocol 4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization 5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period 6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease thrombotic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral artery disease (PAD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accellacare of Piedmont, Piedmont Healthcare

    RECRUITING

    Mooresville, North Carolina, 28117, United States

  • Angel City Research, Inc.

    RECRUITING

    Los Angeles, California, 90010, United States

  • Apex Research Foundation, LLC

    RECRUITING

    Jackson, Tennessee, 38301, United States

  • Applied Research Center of Arkansas

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Axsendo Clinical Research, Integrated Medical Services

    RECRUITING

    Avondale, Arizona, 85392, United States

  • Cardiovascular Solutions

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Epic Medical Research

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Epic Medical Research-Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Hightower Clinical

    RECRUITING

    Oklahoma City, Oklahoma, 73102, United States

  • Lake Martin Medical and Vascular Center

    RECRUITING

    Alexander City, Alabama, 35010, United States

  • Nature Coast Clinical Research - Cardiology

    RECRUITING

    Crystal River, Florida, 34429, United States

  • Pacific Cardiovascular and Vein Institute

    RECRUITING

    Oxnard, California, 93036, United States

  • PharmaTex Research

    RECRUITING

    Amarillo, Texas, 79106, United States

  • Profound Research, Powers Health Medical Group

    RECRUITING

    Munster, Indiana, 46321, United States

  • Tennova TCMC

    RECRUITING

    Knoxville, Tennessee, 37934, United States

  • Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates

    RECRUITING

    Tullahoma, Tennessee, 37388, United States

  • Vital Heart and Vein

    RECRUITING

    Cypress, Texas, 77429, United States

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