NCT06237309

REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a Single Dose of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Patients With Chronic Heart Failure With Reduced Ejection Fraction

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching an experimental drug called REGN5381 (called "study drug"). The study is focused on patients with heart failure with reduced ejection fraction (ie, the heart is not functioning as well as it should). The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: * 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 study drug less effective or could lead to side effects)

Detailed description

Enrollment for the Part A2 low eGFR cohort has been closed

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	REGN5381	Single dose intravenous (IV) infusion
DRUG	Placebo	Single dose IV infusion

Timeline

• Start date: 2024-04-11
• Primary completion: 2025-09-17
• Completion: 2025-12-29
• First posted: 2024-02-01
• Last updated: 2026-01-14

Locations

44 sites across 12 countries: United States, Belgium, Bulgaria, Czechia, Georgia, Greece, Moldova, Poland, Romania, South Africa, South Korea, Spain

Regulatory

• FDA-regulated drug study