NCT06608901

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	REGN7544	Administered per the protocol
DRUG	PB	Administered per the protocol

Timeline

• Start date: 2025-05-05
• Primary completion: 2026-02-01
• Completion: 2026-04-30
• First posted: 2024-09-23
• Last updated: 2026-02-13

Locations

29 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study