Suspended

ESTELLAREGN7544 Antibody for Sepsis-Induced Hypotension

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

REGN7544

+ PB

Drug
Who is being recruted

Cardiovascular Diseases

+ Hypotension

+ Vascular Diseases

From 18 to 85 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorRegeneron Pharmaceuticals
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 5, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new experimental drug called REGN7544 for treating patients with sepsis-induced hypotension. Sepsis is a serious condition caused by an overwhelming infection, leading to dangerously low blood pressure. The study focuses on adults aged 18 to 85 who are hospitalized due to sepsis and are already receiving standard treatments to raise their blood pressure. The main goal is to determine if REGN7544 can safely and effectively help manage low blood pressure in these patients, which is a crucial aspect of their care. Participants in the study will receive REGN7544 in addition to their regular care and will be closely monitored to see how the drug affects their blood pressure and the amount of medication they need to stabilize it. Researchers will also track any side effects, how the drug behaves in the body over time, and whether the body develops antibodies against it, potentially impacting its effectiveness. The study involves regular blood tests and health evaluations to gather this information, ensuring a comprehensive understanding of the drug's impact on sepsis-related low blood pressure.

Official TitleA 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
NCT06608901
Principal SponsorRegeneron Pharmaceuticals
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

76 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHypotensionVascular Diseases

Criteria

2 inclusion criteria required to participate
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

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

9 exclusion criteria prevent from participating
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

Unable to obtain informed consent by participant or Legally Authorized Representative (LAR)

Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia

Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 29 locations

Suspended

Montefiore Medical Center - Weiler Hospital

The Bronx, United StatesOpen Montefiore Medical Center - Weiler Hospital in Google Maps
Suspended

Montefiore Medical Center - Moses Campus

The Bronx, United States
Suspended

Atrium Health

Winston-Salem, United States
Suspended

Cleveland Clinic Foundation

Cleveland, United States
Suspended29 Study Centers