Uncontrolled Hypertension
Conditions
Keywords
High blood pressure, Systolic Blood Pressure (SBP)
Brief summary
This study is researching an experimental drug called REGN5381 (called study drug). The study is focused on uncontrolled hypertension (high blood pressure despite being on one or more antihypertensive drugs). The aim of the study is to see how effective the study drug is in reducing blood pressure. The study is designed as a 2-part study with participants initially enrolling in Part A. Part B of the study will commence and enroll the remaining study participants. 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 drug less effective or could lead to side effects)
Detailed description
As of October 15, 2025, this study has been terminated, and all future onsite visits have been canceled. However, participants have been asked to report safety information to the trial helpline until January 15, 2026.
Interventions
DRUGREGN5381
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Adults with SBP ≥130 mm Hg and SBP ≤180 mm Hg at both screening and randomization visit, as described in the protocol 2. ≥ 40 and ≤85 years on a stable regimen of ≥1 anti-hypertensive therapy for at least 1 month at the time of screening or ≥30 and \<40 years on a stable regimen of ≥3 anti-hypertensive therapies for at least 1 month at the time of screening Key
Exclusion criteria
1. Heart rate \>100 bpm as described in the protocol 2. Body mass index \>45 kg/m2 as described in the protocol 3. Glomerular filtration rate (GFR) \<30 mL/min/1.73m2 at screening as described in the protocol 4. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN) as described in the protocol NOTE: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unattended Automated Office-Based Blood Pressure (AOBP) Systolic Blood Pressure (SBP) | At week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Unattended AOBP SBP in participants on ≥3 anti-hypertensive therapies | At week 12 |
| Time-weighted average AOBP SBP | Through week 12 |
| Time-weighted average AOBP Diastolic Blood Pressure (DBP) | Through week 12 |
| AOBP SBP | From baseline to weeks 2, 4 and 8 |
| AOBP DBP | From baseline to weeks 2, 4, 8 and 12 |
| Mean SBP by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | At week 12 |
| Unattended AOBP SBP in stage 3 Chronic Kidney Disease (CKD) participants | At week 12 |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to week 23 |
| Severity of TEAEs | Up to week 23 |
| Occurrence of TEAEs leading to discontinuation of study drug | Up to week 23 |
| Occurrence of Anti-Drug Antibodies (ADAs) to REGN5381 | Through week 20 |
| Titer of ADAs to REGN5381 | Through week 20 |
| Concentrations of REGN5381 in serum | Through week 20 |
Countries
United Kingdom
Outcome results
None listed