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REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction

NCT06237309 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2026-01-14

No results posted yet for this study

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)

Conditions

Interventions

DRUG

REGN5381

Single dose intravenous (IV) infusion

DRUG

Placebo

Single dose IV infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials Administrator · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2025-09-17
Completion
2025-12-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Czechia
  • Georgia
  • Greece
  • Moldova
  • Poland
  • Romania
  • South Africa
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237309 on ClinicalTrials.gov