Sepsis-Induced HypotensionPhase 2ESTELLANCT06608901
A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
A Phase 2 study testing REGN7544 and PB in people with Sepsis-Induced Hypotension, run by Regeneron Pharmaceuticals at 29 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis-Induced Hypotension
- What is being tested?
- REGN7544 and PB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 5 May 2025to 28 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States16 sites
Emory University Hospital
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
New York University Langone Health Brooklyn Hospital
Brooklyn, New York, 11220
MUSC SCTR Research Nexus Clinic and Lab
Charleston, South Carolina, 29425
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Intermountain Medical Center - Murray (Pulmonary Medicine)
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06510
Bellevue Hospital
New York, New York, 10016
New York University Langone Health Tisch-Kimmel Hospital
New York, New York, 10016
Montefiore Medical Center - Weiler Hospital
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
University of Arizona
Tucson, Arizona, 85724
Atrium Health
Winston-Salem, North Carolina, 27157
France13 sites
Centre Hospitalier Universitaire Angers
Angers, 49933
Raymond Poincare University Hospital
Garches, 92380
Centre Hospitalier Departemental (CHD) Vendee
La Roche-sur-Yon, Vendee, 85925
Paris-Saclay University Hospitals
Le Kremlin-Bicêtre, 94270
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, 72037
CHU Dupuytren
Limoges, New Aquitaine, 87042
CHU Nantes
Nantes, 44093
Centre Hospitalier Universitaire d'Orleans
Orléans, 45064
Hopital Cochin
Paris, Île-de-France Region, 75014
CHU de Reims Hopital Robert Debre
Reims, 51100
Hopitaux Universitaires de Strasbourg
Strasbourg, 67091
Centre Hospitalier Regional Universaitaire de Tours (CHRU de Tours)
Tours, Centre-Val de Loire, 37000
Hopital Nord Franche Comte
Trévenans, 90400
About this study
Official 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
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.
Read more
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
- Being tested
- REGN7544, PB
- Keywords
- Natriuretic Peptide Receptor 1 (NPR1), Low Blood Pressure
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7544Drug
Administered per the protocol
PBDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| REGN7544 | Experimental | Not described Receives: Drug: REGN7544 |
| Placebo (PB) | Placebo comparator | Not described Receives: Drug: PB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative vasopressor dose
Measured: Through 72 Hours
Secondary outcomes (10)
Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs)
Measured: Through 90 Days
Time-weighted average Mean Arterial Pressure (MAP)
Measured: Baseline Over 4 Hours
Change in MAP
Measured: Baseline, At 4 Hours
Proportion of surviving participants free of vasopressor(s)
Measured: At 24, 48 and 72 Hours
Cumulative net fluid balance
Measured: Through 72 Hours
Cumulative urine output
Measured: Through 72 Hours
Cumulative fluid intake
Measured: Through 72 Hours
Concentrations of REGN7544 in serum
Measured: Through 90 Days
Incidence of Anti-Drug Antibodies (ADA) to REGN7544
Measured: Through 90 Days
Magnitude of ADA to REGN7544
Measured: Through 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start5 May 2025
- Primary completion1 Feb 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis-Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608901
- Sponsor's protocol ID
- R7544-SIH-2435
- Other IDs
- 2024-514946-35-00
- Acronym
- ESTELLA
- Status last verified
- May 2026
- First submitted
- 19 Sep 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06608901
- Acronym / sponsor ID
- ESTELLA / R7544-SIH-2435
- Conditions
- Sepsis-Induced Hypotension
- Keywords
- Natriuretic Peptide Receptor 1 (NPR1), Low Blood Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGN7544 | Experimental | Drug: REGN7544 |
| Placebo (PB) | Placebo comparator | Drug: PB |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN7544Administered per the protocol | Drug | REGN7544 |
| PBAdministered per the protocol | Drug | Placebo (PB) |
Primary outcome
Cumulative vasopressor dose
Time frame: Through 72 Hours
10 secondary outcomes
Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through 90 Days
Time-weighted average Mean Arterial Pressure (MAP)
Time frame: Baseline Over 4 Hours
Change in MAP
Time frame: Baseline, At 4 Hours
Proportion of surviving participants free of vasopressor(s)
Time frame: At 24, 48 and 72 Hours
Cumulative net fluid balance
Time frame: Through 72 Hours
Cumulative urine output
Time frame: Through 72 Hours
Cumulative fluid intake
Time frame: Through 72 Hours
Concentrations of REGN7544 in serum
Time frame: Through 90 Days
Incidence of Anti-Drug Antibodies (ADA) to REGN7544
Time frame: Through 90 Days
Magnitude of ADA to REGN7544
Time frame: Through 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REGN7544 and PB in people with Sepsis-Induced Hypotension, run by Regeneron Pharmaceuticals at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative vasopressor dose (time frame: Through 72 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.