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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514946-35-00

Acronym

R7544-SIH-2435

Enrollment

Registered

2025-02-19

Start date

2025-06-24

Completion date

Unknown

Last updated

2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-Induced Hypotension

Brief summary

Cumulative vasopressor dose.

Detailed description

Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs)., Time-weighted average mean arterial pressure (MAP)., Change in MAP., Proportion of surviving participants free of vasopressor(s)., Cumulative net fluid balance., Cumulative urine output., Cumulative fluid intake., Concentrations of REGN7544 in serum., Incidence of anti-drug antibodies (ADA) to REGN7544., Magnitude of ADA to REGN7544.

Interventions

DRUGREGN7544

DRUGREGN7544 Matching Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cumulative vasopressor dose.	—

Secondary

Measure	Time frame
Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs)., Time-weighted average mean arterial pressure (MAP)., Change in MAP., Proportion of surviving participants free of vasopressor(s)., Cumulative net fluid balance., Cumulative urine output., Cumulative fluid intake., Concentrations of REGN7544 in serum., Incidence of anti-drug antibodies (ADA) to REGN7544., Magnitude of ADA to REGN7544.	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026