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NCT Number: NCT06608901

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

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)

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Key information

Conditions

Sepsis-Induced Hypotension Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Regional Universaitaire de Tours (CHRU de Tours), Tours, Centre-Val de Loire, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

NOTE: Other Protocol-Defined Inclusion-Exclusion Criteria Apply

Treatment and study plan

REGN7544

Drug

Administered per the protocol

PB

Drug

Administered per the protocol

Primary outcomes

  1. Cumulative vasopressor dose

    Time frame: Through 72 Hours

Secondary outcomes

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

    Time frame: Through 90 Days

  2. Time-weighted average Mean Arterial Pressure (MAP)

    Time frame: Baseline Over 4 Hours

  3. Change in MAP

    Time frame: Baseline, At 4 Hours

  4. Proportion of surviving participants free of vasopressor(s)

    Time frame: At 24, 48 and 72 Hours

  5. Cumulative net fluid balance

    Time frame: Through 72 Hours

  6. Cumulative urine output

    Time frame: Through 72 Hours

  7. Cumulative fluid intake

    Time frame: Through 72 Hours

  8. Concentrations of REGN7544 in serum

    Time frame: Through 90 Days

  9. Incidence of Anti-Drug Antibodies (ADA) to REGN7544

    Time frame: Through 90 Days

  10. Magnitude of ADA to REGN7544

    Time frame: Through 90 Days

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients With Sepsis-Induced Hypotension

Acronym: ESTELLA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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