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New shot could replace pills to prevent clots after knee surgery

NCT ID NCT07015905

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study tests an experimental drug called REGN7508 (cenvacibart) to prevent venous thromboembolism (blood clots) in adults after elective total knee replacement. About 2,000 participants will receive either REGN7508, apixaban, or enoxaparin to compare effectiveness and safety. The goal is to see if REGN7508 works as well or better than standard blood thinners with fewer side effects.

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), a monoclonal antibody that blocks factor XI to prevent blood clots
What this could lead to
If successful, REGN7508 could offer a new option to prevent dangerous blood clots after knee replacement surgery, potentially with fewer bleeding risks than current treatments.
What could go wrong
This is a large Phase 3 trial, but the drug is still experimental. It may not prove safer or more effective than existing blood thinners, and there is always a risk of unexpected side effects like bleeding or allergic reactions.

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 2,000 people

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

Started

Jun 2025

Expected to finish

May 2027

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. Is undergoing a primary elective unilateral TKA 2. Is in good health based on laboratory safety testing as described in the protocol 3. Body weight ≤130 kg at screening visit as described in the protocol Key Exclusion Criteria: 1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation 2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol 3. History of thromboembolic disease or thrombophilia 4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization 5. Has an estimated Glomerular Filtration Rate (GFR) of \<30 mL/min/1.73 m2 at the screening visit as described in the protocol Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

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Conditions

The condition(s) this trial relates to.

venous thromboembolism prevention target

As listed by the trial registrant

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

Venous thromboembolism (VTE)

How to take part

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

  1. The places running it

    47 sites in 8 countries. 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

  • ARENSIA Exploratory Medicine, County Hospital Cluj-Napoca

    RECRUITING

    Cluj-Napoca, 400006, Romania

  • Arensia Clinics S.R.L

    RECRUITING

    Bucharest, 011658, Romania

  • Bioresearch Partner

    RECRUITING

    Miami, Florida, 33175, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CARI Clinical Trials

    RECRUITING

    Riverside, California, 92504, United States

  • Curalta Clinical Trials

    RECRUITING

    Westwood, New Jersey, 07675, United States

  • DRx Clinical Research, LLC

    RECRUITING

    St. George, Utah, 84770, United States

  • DRx Clinical Research, LLC; South Texas Bone and Joint Institute

    RECRUITING

    San Antonio, Texas, 78249, United States

  • Delray Physician Care Center

    RECRUITING

    Delray Beach, Florida, 33445, United States

  • Denver Metro Orthopedics, P.C. Englewood Location

    RECRUITING

    Englewood, Colorado, 80113, United States

  • Duke University Health System (Duke Health), Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Flourish Research - San Antonio (Formerly Clinical Trials of Texas)

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Futuro Clinical Trials

    RECRUITING

    McAllen, Texas, 78501, United States

  • Gulfcoast Research Institute

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz

    RECRUITING

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • HD Research - First Surgical Hospital

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Hospital of Traumatology and Orthopaedics

    RECRUITING

    Riga, LV-1005, Latvia

  • Juntendo University Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kansai Rosai Hospital

    RECRUITING

    Amagasaki-shi, Hyōgo, 660-8511, Japan

  • Keystone Clinical Studies LLC, dba Flourish Research

    RECRUITING

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Liepajas regionala slimnica; SIA

    RECRUITING

    Liepāja, LV-3414, Latvia

  • Lietuvos sveikatos mokslu universiteto Kauno ligonine

    RECRUITING

    Kaunas, LT-47144, Lithuania

  • Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik

    RECRUITING

    Kaunas, LT-50161, Lithuania

  • Multi-profile Hospital for Active Treatment Hearth and Brain EAD

    RECRUITING

    Pleven, 5804, Bulgaria

  • Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia),

    RECRUITING

    Sofia, 1404, Bulgaria

  • National Hospital Organization Osaka Minami Medical Center

    RECRUITING

    Kawachi-Nagano, Osaka, 586-8521, Japan

  • NextStage Clinical Research, All American Orthopedics and Sports Medicine

    RECRUITING

    Houston, Texas, 77058, United States

  • ORTO Klinika

    RECRUITING

    Riga, LV-1005, Latvia

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego w Poznaniu

    RECRUITING

    Poznan, 61-545, Poland

  • Osaka Saiseikai Nakatsu Hospital

    RECRUITING

    Kita-Ku, Osaka, 530-0012, Japan

  • Phoenix Clinical Research

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Rigas 2 slimnica, SIA

    RECRUITING

    Riga, LV-1004, Latvia

  • Sacred Heart Health System Inc

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Saga University Hospital

    RECRUITING

    Saga, 849-8501, Japan

  • Samodzieny Publiczny Zaklad Opieki Zdorowotne (SP ZOZ) Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi - Hematology

    RECRUITING

    Lodz, 92-213, Poland

  • Semmelweis University

    RECRUITING

    Budapest, 1082, Hungary

  • Shoals Medical Trials, Inc.

    RECRUITING

    Sheffield, Alabama, 35660, United States

  • Sinai Hospital of Baltimore, Inc.

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • Szegedi Tudomanyegyetem; Albert Szent-Gyorgyi Clinical Center

    RECRUITING

    Szeged, Csongrad-Csanad, 6725, Hungary

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.

    RECRUITING

    Krakow, 31-826, Poland

  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"

    RECRUITING

    Stara Zagora, 6003, Bulgaria

  • University of Debrecen

    RECRUITING

    Debrecen, Hajdú-Bihar, 4031, Hungary

  • University of Texas (UT); Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Uniwersytecki Szpital Kliniczny nr.2 Uniwersytetu Medycznego w Lodzi

    RECRUITING

    Lodz, 90-549, Poland

  • Vidzemes slimnica

    RECRUITING

    Valmiera, LV-4201, Latvia

  • Vsi Klaipedos Universitetine Ligonine

    RECRUITING

    Klaipėda, LT-92288, Lithuania

  • Yuuai Medical Center

    RECRUITING

    Tomigusuku, Okinawa, 901-0224, Japan

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Other studies related to the condition(s) this trial covers.