A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension

NCT06608901 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: R7544-SIH-24352024-514946-35-00
• Study Type: interventional
• Target: 76
• Locations: 2 countries
• Sites: 29

Brief Summary

This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on adult patients (18 to 85 years) hospitalized due to a serious infection (called "sepsis") and receiving standard-of-care medications for low blood pressure (called "vasopressors") due to sepsis. The aim of the study is to see how safe, tolerable, and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during the stay in the hospital. The study is looking at several other research questions, including:

• How the study drug changes the blood pressure and the amount of intravenous (IV) fluids given to participants with low blood pressure due to sepsis
• What side effects may happen from taking the study drug
• How much study drug is in the blood at different times
• Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Conditions

Sepsis-Induced Hypotension

Keywords

Natriuretic Peptide Receptor 1 (NPR1); Low Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Cumulative vasopressor dose

  Through 72 Hours

Secondary Outcomes (10)

• Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs)

  Through 90 Days

• Time-weighted average Mean Arterial Pressure (MAP)

  Baseline Over 4 Hours

• Change in MAP

  Baseline, At 4 Hours

• Proportion of surviving participants free of vasopressor(s)

  At 24, 48 and 72 Hours

• Cumulative net fluid balance

  Through 72 Hours

Study Arms (2)

REGN7544

EXPERIMENTAL

Drug: REGN7544

Placebo (PB)

PLACEBO COMPARATOR

Drug: PB

Interventions

REGN7544 DRUG

Administered per the protocol

REGN7544

PB DRUG

Administered per the protocol

Placebo (PB)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period
• 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

You may not qualify if:

• Unable to obtain informed consent by participant or Legally Authorized Representative (LAR)
• Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
• Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest
• Ejection fraction \<20% in the most recent known echocardiogram
• Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization
• 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
• Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol
• 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
• Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (29)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Harvard Medical School - Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

New York University Langone Health Brooklyn Hospital

Brooklyn, New York, 11220, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

New York University Langone Health Tisch-Kimmel Hospital

New York, New York, 10016, United States

Location

Montefiore Medical Center - Weiler Hospital

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Atrium Health

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MUSC SCTR Research Nexus Clinic and Lab

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Intermountain Medical Center - Murray (Pulmonary Medicine)

Murray, Utah, 84107, United States

Location

Centre Hospitalier Regional Universaitaire de Tours (CHRU de Tours)

Tours, Centre-Val de Loire, 37000, France

Location

CHU Dupuytren

Limoges, Nouvelle-Aquitaine, 87042, France

Location

Centre Hospitalier Le Mans

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

Location

Centre Hospitalier Departemental (CHD) Vendee

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

Location

Centre Hospitalier Universitaire Angers

Angers, 49933, France

Location

Raymond Poincare University Hospital

Garches, 92380, France

Location

Paris-Saclay University Hospitals

Le Kremlin-Bicêtre, 94270, France

Location

CHU Nantes

Nantes, 44093, France

Location

Centre Hospitalier Universitaire d'Orleans

Orléans, 45064, France

Location

CHU de Reims Hopital Robert Debre

Reims, 51100, France

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Hopital Nord Franche Comte

Trévenans, 90400, France

Location

Hopital Cochin

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

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: May 5, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (16); FR (13)