REGN5381 for Heart Failure

(NATRIX-BNP Trial)

Not currently recruiting at 67 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Must be taking: Sacubitril-valsartan

Disqualifiers: Recent MI, Syncope, Cardiac surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, REGN5381, to determine its potential benefits for people with heart failure, particularly those with impaired heart pumping. Researchers aim to assess the drug's safety and effectiveness, as well as any possible side effects. They also examine how the body processes the drug and whether it triggers immune reactions that could reduce its effectiveness. Individuals managing chronic heart failure and experiencing symptoms like shortness of breath or fatigue might be suitable for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in heart failure treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it mentions that participants should be on optimized standard care for heart failure. If you are taking sacubitril-valsartan, you may continue it under certain conditions.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that REGN5381, a new treatment being tested for heart failure, has promising safety results. In earlier studies, researchers administered a single dose of REGN5381 to people with mild high blood pressure. Most participants tolerated the treatment well, experiencing no serious side effects. The effects lasted up to four days, and the side effect profile was considered acceptable.

While these early results are encouraging, it's important to remember that this treatment remains under study. Further research will clarify its safety and effectiveness for people with heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

REGN5381 is unique because it offers a fresh approach to treating heart failure by potentially targeting pathways not addressed by current medications like beta-blockers, ACE inhibitors, or sacubitril-valsartan. Unlike traditional treatments that often focus on managing symptoms through existing mechanisms, REGN5381 may provide new therapeutic benefits by modulating a novel biological pathway. Researchers are excited about this because it could lead to better outcomes for patients who don't fully respond to existing therapies, offering hope for enhanced heart function and quality of life.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that REGN5381, a new drug tested in this trial, may help treat heart failure with reduced ejection fraction. Participants will receive different doses of REGN5381 or a placebo, depending on their assigned treatment arm. Studies have found that REGN5381 lowers vein pressure, which can cause heart failure symptoms. This may help the heart function better in individuals whose hearts aren't pumping well. Early results suggest the drug could have long-lasting effects, possibly improving patients' quality of life. Although more research is needed, these initial findings are promising for those with heart failure. ^{2 5 6 7 8}

Who Is on the Research Team?

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.

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?

Group I: Part B Low Dose Experimental Treatment 2 Interventions

Group II: Part B High Dose Experimental Treatment 2 Interventions

Group III: Part A2 Low Dose, sacubitril-valsartan group Experimental Treatment 1 Intervention

Single ascending dose cohort

Group IV: Part A2 Low Dose, Low eGFR group Experimental Treatment 1 Intervention

Single ascending dose cohort. Note: This group has been closed

Group V: Part A2 High Dose, sacubitril-valsartan group Experimental Treatment 1 Intervention

Single ascending dose cohort

Group VI: Part A2 High Dose, Low estimated glomerular filtration rate (eGFR) group Experimental Treatment 1 Intervention

Single ascending dose cohort. Note: This group has been closed

Group VII: Part A1 Optional Experimental Treatment 2 Interventions

Single ascending dose cohort

Group VIII: Part A1 Low Dose Experimental Treatment 2 Interventions

Single ascending dose cohort

Group IX: Part A1 High Dose Experimental Treatment 2 Interventions

Single ascending dose cohort

Group X: Placebo for Part A2, Low eGFR group Placebo Group 1 Intervention

Note: This group has been closed

Group XI: Part A1 and Part B Placebo Only Placebo Group 1 Intervention

Group XII: Placebo for Part A2, sacubitril-valsartan group Placebo Group 1 Intervention

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

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06237309

REGN5381 in Adult Participants With Heart Failure With ... 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 ...

2. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy00000019voEAA/nct06237309

REGN5381 in Adult Participants With Heart Failure With ... 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 ...

3. clinconnect.io clinconnect.io/trials/NCT06237309

REGN5381 in Adult Participants With Heart Failure With This clinical trial is looking at a new experimental medication called REGN5381 for adults with heart failure, specifically those whose hearts do not pump blood ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11410649/

Agonist antibody to guanylate cyclase receptor NPR1 ... These data support the development of REGN5381 for long-lasting and selective lowering of venous pressures that drive symptomatology in patients with heart ...

5. clinicaltrials.eu clinicaltrials.eu/inn/regn5381/

REGN5381: A Promising New Drug for Heart Failure ... REGN5381 is an experimental drug that is currently being studied for its potential in treating heart conditions, particularly heart failure.

6. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.13840

Abstract 13840: Safety Outcomes From a First-in-Human ... REGN5381, a novel investigational NPR1 agonist monoclonal antibody, showed sustained hemodynamic effects in animal models.

7. jacc.org jacc.org/doi/10.1016/S0735-1097%2824%2903696-9

EFFECTS OF REGN5381, A NATRIURETIC PEPTIDE ... A single-dose REGN5381 showed sustained hemodynamic effects up to day 4 with an acceptable safety profile in mildly hypertensive adults.

8. ctv.veeva.com ctv.veeva.com/study/a-trial-to-learn-how-regn5381-works-and-how-safe-it-is-in-adults-with-heart-failure-with-reduced-eje

REGN5381 in Adult Participants With Heart Failure With ... This study is researching an experimental drug called REGN5381 (called study drug). The study is focused on patients with heart failure with reduced ejection ...