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Experimental antibody aims to stabilize blood pressure in sepsis patients

NCT ID NCT06608901

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called REGN7544 in 76 adults hospitalized with sepsis and low blood pressure. The drug is an antibody designed to help raise blood pressure and reduce the need for standard medications. Researchers measured safety, blood pressure changes, and total vasopressor use during the hospital stay.

What this could mean

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

Active substance
REGN7544 (an experimental antibody)
What this could lead to
If it works, this could lead to a new treatment to stabilize blood pressure in sepsis patients, reducing the need for standard vasopressors.
What could go wrong
This is a small, early Phase 2 trial with only 76 participants. The drug may not improve outcomes or could cause side effects. Results may not apply to all sepsis patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

76 people

The number who actually took part.

Started

May 2025

Finished

Apr 2026

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 to 85 years

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. Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period 2. Sepsis-induced hypotension that has not responded to Intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol Key Exclusion Criteria: 1. Unable to obtain informed consent by participant or Legally Authorized Representative (LAR) 2. Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol 3. Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest 4. Ejection fraction \<20% in the most recent known echocardiogram 5. Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization 6. History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months 7. Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol 8. Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration 9. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia NOTE: Other Protocol-Defined Inclusion-Exclusion Criteria Apply

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Conditions

The condition(s) this trial relates to.

hypotensive disorder

As listed by the trial registrant

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

Sepsis-induced hypotension

Contacts and locations

Locations

  • Atrium Health

    Winston-Salem, North Carolina, 27157, United States

  • Bellevue Hospital

    New York, New York, 10016, United States

  • CHU Dupuytren

    Limoges, New Aquitaine, 87042, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU de Reims Hopital Robert Debre

    Reims, 51100, France

  • Centre Hospitalier Departemental (CHD) Vendee

    La Roche-sur-Yon, Vendee, 85925, France

  • Centre Hospitalier Le Mans

    Le Mans, Pays de la Loire Region, 72037, France

  • Centre Hospitalier Regional Universaitaire de Tours (CHRU de Tours)

    Tours, Centre-Val de Loire, 37000, France

  • Centre Hospitalier Universitaire Angers

    Angers, 49933, France

  • Centre Hospitalier Universitaire d'Orleans

    Orléans, 45064, France

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Harvard Medical School - Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Hopital Cochin

    Paris, Île-de-France Region, 75014, France

  • Hopital Nord Franche Comte

    Trévenans, 90400, France

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

  • Intermountain Medical Center - Murray (Pulmonary Medicine)

    Murray, Utah, 84107, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • MUSC SCTR Research Nexus Clinic and Lab

    Charleston, South Carolina, 29425, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center - Weiler Hospital

    The Bronx, New York, 10461, United States

  • New York University Langone Health Brooklyn Hospital

    Brooklyn, New York, 11220, United States

  • New York University Langone Health Tisch-Kimmel Hospital

    New York, New York, 10016, United States

  • Paris-Saclay University Hospitals

    Le Kremlin-Bicêtre, 94270, France

  • Raymond Poincare University Hospital

    Garches, 92380, France

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Yale University

    New Haven, Connecticut, 06510, United States