391 Participants Needed

REGN5381 for Heart Failure

(NATRIX-BNP Trial)

Recruiting at 34 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Regeneron Pharmaceuticals
Must be taking: Sacubitril-valsartan
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Who Is on the Research Team?

CT

Clinical Trials Administrator

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with chronic heart failure where the heart's pumping power is reduced (ejection fraction of 20-49%). Participants must have a BMI between 18 and 40, high levels of NT-proBNP in their blood, and be on optimized standard heart failure therapy. People with certain kidney function levels can join specific subgroups.

Inclusion Criteria

I meet the main requirements to participate.
My kidney function test shows eGFR between 30-45.
My body mass index (BMI) is between 18 and 40 at the time of my first screening visit.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of REGN5381 or placebo to evaluate safety, pharmacokinetics, and pharmacodynamics

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, side effects, and antibody development against the study drug

4 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • REGN5381
Trial Overview The study tests REGN5381 against a placebo to evaluate its safety, tolerability, and effectiveness in treating heart failure with reduced ejection fraction. It also examines how much drug is present in the blood over time and if the body creates antibodies against it.
How Is the Trial Designed?
12Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B Low DoseExperimental Treatment2 Interventions
Group II: Part B High DoseExperimental Treatment2 Interventions
Group III: Part A2 Low Dose, sacubitril-valsartan groupExperimental Treatment1 Intervention
Group IV: Part A2 Low Dose, Low eGFR groupExperimental Treatment1 Intervention
Group V: Part A2 High Dose, sacubitril-valsartan groupExperimental Treatment1 Intervention
Group VI: Part A2 High Dose, Low estimated glomerular filtration rate (eGFR) groupExperimental Treatment1 Intervention
Group VII: Part A1 OptionalExperimental Treatment2 Interventions
Group VIII: Part A1 Low DoseExperimental Treatment2 Interventions
Group IX: Part A1 High DoseExperimental Treatment2 Interventions
Group X: Placebo for Part A2, sacubitril-valsartan groupPlacebo Group1 Intervention
Group XI: Placebo for Part A2, Low eGFR groupPlacebo Group1 Intervention
Group XII: Part A1 and Part B Placebo OnlyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

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