Investigating REGN5381 for 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
This study is testing a new drug called REGN5381 to see if it can help adults with heart failure feel better and manage their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 391 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 15 sites (Alken, Limburg and 14 other locations) |
| Trial ID | NCT06237309 on ClinicalTrials.gov |
What this trial studies
This study is evaluating the safety, tolerability, and effectiveness of an experimental drug called REGN5381 in adults diagnosed with heart failure with reduced ejection fraction (HFrEF). Participants will receive either the study drug or a placebo, and the study will monitor various outcomes, including side effects, drug levels in the blood, and the body's immune response to the drug. The research aims to gather important data that could inform future treatments for heart failure.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic heart failure, a left ventricular ejection fraction between 20-49%, and elevated NT-proBNP levels.
Not a fit: Patients who have been recently hospitalized or have uncontrolled blood pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from heart failure with reduced ejection fraction.
How similar studies have performed: Other studies have shown promise in treating heart failure with novel approaches, but the specific use of REGN5381 is a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria 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 Key Exclusion Criteria 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
Where this trial is running
Alken, Limburg and 14 other locations
- Anima Research Center — Alken, Limburg, Belgium (Recruiting)
- Onze Lieve Vrouw Ziekenhuis Aalst — Aalst, Oost-Vlaanderen, Belgium (Recruiting)
- UZ Leuven — Leuven, Vlaams Brabant, Belgium (Recruiting)
- Algemeen Ziekenhuis St Jan Brugge Oostende Av — Bruges, West Flanders, Belgium (Recruiting)
- AZ Oostende — Oostende, West Vlaanderen, Belgium (Recruiting)
- Centre Hospitalier Regional de la Citadelle — Liege, Belgium (Recruiting)
- Arensia Exploratory Medicine Clinic at MBAL Sveta Sofia — Sofia, Bulgaria (Recruiting)
- Pmsi Republican Clinical Hospital Timofei Mosneaga — Chisinau, Moldova, Republic of (Recruiting)
- Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital — Torun, Kuyavian-Pomeranian, Poland (Recruiting)
- UCK Medical University of Warsaw — Warszawa, Mazowieckie, Poland (Recruiting)
- Medical University of Lodz — Lodz, Poland (Recruiting)
- Arensia Exploratory Medicine Clinic at Monza Bucharest — Bucharest, Romania (Recruiting)
- Sc Arensia Exploratory Medicine Srl — Cluj Napoca, Romania (Recruiting)
- Virgen de las Montañas Hospital — Villamartin, Cadiz, Spain (Recruiting)
- Hospital Universitario Virgen Macarena Unidad Coronaria 1 planta — Sevilla, Spain (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.