Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Torrance 5403022, California 5332921 and other locations
Dates
study started
study ends around

Description

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)

Official Title

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

Keywords

Heart Failure, Heart failure with reduced ejection fraction (HFrEF), Reduced ejection fraction, N-terminal pro-brain natriuretic peptide (NT-proBNP) hormone, Counterfeit Drugs, REGN5381

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Body mass index (BMI) between 18 and 45 kg/m2, inclusive, at initial screening visit
  2. Diagnosis of chronic heart failure
  3. Left ventricular ejection fraction 20-49% by echocardiogram performed within 3 months of screening
  4. Plasma NT-proBNP ≥800 pg/mL (or ≥1000 pg/mL if in atrial fibrillation) at screening (visit 1) and NT-proBNP ≥600 pg/mL (or ≥800 pg/mL if in atrial fibrillation) approximately 30 days prior to randomization (visit 5)
  5. Receiving optimized standard of care therapy for heart failure as described in the protocol
  6. Sacubitril-valsartan cohort only: treatment with sacubitril-valsartan at screening and at baseline
  7. Low eGFR cohort only: eGFR of 30-45 mL/min/1.73 m2 at screening and within approximately 30 days of randomization

You CAN'T join if...

  1. Hospital discharge within 180 days of anticipated randomization
  2. Resting SBP that remains out of range after two repeated measurements prior to randomization as described in the protocol
  3. Estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73 m2 according to locally used formula (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] preferred), at screening (eGFR of 30-45 mL/min/1.73 m2 required for participants in the low eGFR cohort)
  4. Current or recent diagnosis of acute coronary syndrome or myocardial infarction as described in the protocol
  5. History of symptomatic autonomic dysfunction as evidenced by orthostatic hypotension and/or syncope
  6. Unexplained syncope <12 months prior to initial screening or during the Run-in period
  7. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confer unreasonable risk to the participant's participation in the study
  8. Uncorrected congenital heart disease
  9. Cardiac surgery within 6 months prior to screening or any planned surgery during the study
  10. Implantation of a cardiac resynchronization therapy device in the prior 90 days, or planned during the study, or planned device optimization 30 days prior to randomization or during the study
  11. Current chronic lung disease requiring long-term oxygen therapy

Note: Other protocol-defined inclusion/ exclusion criteria apply

Locations

  • Harbor UCLA Medical Center accepting new patients
    Torrance 5403022 California 5332921 90509 United States
  • Arensia Exploratory Medicine Clinic accepting new patients
    Phoenix 5308655 Arizona 5551752 85015 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT06237309
Phase
Phase 2 Heart Failure Research Study
Study Type
Interventional
Participants
Expecting 391 study participants
Last Updated