REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction
- Registration Number
- NCT06237309
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief 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)
- Detailed Description
Enrollment for the Part A2 low eGFR cohort has been closed
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 394
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A1 High Dose REGN5381 Single ascending dose cohort Part A1 Low Dose REGN5381 Single ascending dose cohort Placebo for Part A2, Low eGFR group Placebo Note: This group has been closed Part B Low Dose REGN5381 - Part A1 Optional REGN5381 Single ascending dose cohort Placebo for Part A2, sacubitril-valsartan group Placebo - Part A2 Low Dose, Low eGFR group REGN5381 Single ascending dose cohort. Note: This group has been closed Part B High Dose REGN5381 - Part A2 High Dose, sacubitril-valsartan group REGN5381 Single ascending dose cohort Part A2 Low Dose, sacubitril-valsartan group REGN5381 Single ascending dose cohort Part A2 High Dose, Low estimated glomerular filtration rate (eGFR) group REGN5381 Single ascending dose cohort. Note: This group has been closed Part A1 and Part B Placebo Only Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in circulating N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) Day 8
- Secondary Outcome Measures
Name Time Method Occurrence of Treatment Emergent Adverse Events (TEAEs) Through week 16 Severity of TEAEs Through week 16 Change from baseline in circulating NT-proBNP Up to week 16 Change from baseline in Systolic Blood Pressure (SBP) Each visit through week 16 Change from baseline in Diastolic Blood Pressure (DBP) Each visit through week 16 Change from baseline in Mean Arterial Pressure (MAP) Each visit through week 16 Change from baseline in Heart Rate (HR) Each visit through week 16 Concentrations of REGN5381 in serum Through week 16 Incidence of Anti-Drug Antibodies (ADAs) to REGN5381 Through week 16 Magnitude of ADAs to REGN5381 Through week 16
Trial Locations
- Locations (44)
Arensia Exploratory Medicine at the Research Institute of Clinical Medicine
🇬🇪Tbilisi, Georgia
First Cardiology Clinic University of Athens
🇬🇷Athens, Attica, Greece
Arensia Exploratory Medicine Clinic
🇺🇸Phoenix, Arizona, United States
Harbor UCLA Medical Center
🇺🇸Torrance, California, United States
Flourish Research - Miami (Kendall) (Formerly Clinical Site Partners)
🇺🇸Miami, Florida, United States
Flourish Research - Orlando (Formerly Clinical Site Partners)
🇺🇸Winter Park, Florida, United States
Grand Hopital de Charleroi
🇧🇪Gilly, Hainaut, Belgium
Anima Research Center
🇧🇪Alken, Limburg, Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Oost-Vlaanderen, Belgium
UZ Leuven
🇧🇪Leuven, Vlaams Brabant, Belgium
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