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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 391
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A2 Low Dose, Low eGFR group REGN5381 Single ascending dose cohort Part B High Dose REGN5381 - Part B Low Dose REGN5381 - Part A1 and Part B Placebo Only Placebo - Placebo for Part A2, sacubitril-valsartan group Placebo - Part A2 High Dose, Low estimated glomerular filtration rate (eGFR) group REGN5381 Single ascending dose cohort Placebo for Part A2, Low eGFR group Placebo - Part A1 High Dose REGN5381 Single ascending dose cohort Part A1 Low Dose REGN5381 Single ascending dose cohort Part A1 Optional REGN5381 Single ascending dose cohort Part A2 High Dose, sacubitril-valsartan group REGN5381 Single ascending dose cohort Part A2 Low Dose, sacubitril-valsartan group REGN5381 Single ascending dose cohort
- 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 Change from baseline in heart rate (HR) Each visit through week 16 Occurrence of treatment emergent adverse events (TEAEs) Through week 16 Severity of TEAEs Through week 16 Change from baseline in systolic blood pressure (SBP) Each visit through week 16 Incidence of anti-drug antibodies (ADAs) to REGN5381 Through week 16 Change from baseline in diastolic blood pressure (DBP) Each visit through week 16 Change from baseline in circulating NT-proBNP Up to week 16 Change from baseline in mean arterial pressure (MAP) Each visit through week 16 Titer of ADAs to REGN5381 Through week 16 Concentrations of REGN5381 in serum Through week 16
Trial Locations
- Locations (15)
Hospital Universitario Virgen Macarena Unidad Coronaria 1 planta
🇪🇸Sevilla, Spain
Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital
🇵🇱Torun, Kuyavian-Pomeranian, Poland
UCK Medical University of Warsaw
🇵🇱Warszawa, Mazowieckie, Poland
Anima Research Center
🇧🇪Alken, Limburg, Belgium
AZ Oostende
🇧🇪Oostende, West Vlaanderen, Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Oost-Vlaanderen, Belgium
Medical University of Lodz
🇵🇱Lodz, Poland
UZ Leuven
🇧🇪Leuven, Vlaams Brabant, Belgium
Pmsi Republican Clinical Hospital Timofei Mosneaga
🇲🇩Chisinau, Moldova, Republic of
Algemeen Ziekenhuis St Jan Brugge Oostende Av
🇧🇪Bruges, West Flanders, Belgium
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege, Belgium
Arensia Exploratory Medicine Clinic at MBAL Sveta Sofia
🇧🇬Sofia, Bulgaria
Virgen de las Montañas Hospital
🇪🇸Villamartin, Cadiz, Spain
Arensia Exploratory Medicine Clinic at Monza Bucharest
🇷🇴Bucharest, Romania
Sc Arensia Exploratory Medicine Srl
🇷🇴Cluj Napoca, Romania