Testing REGN5381 for high blood pressure management
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Multiple Dose Regimen of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Participants With Uncontrolled Hypertension
PHASE2 · Regeneron Pharmaceuticals · NCT06833190
This study is testing a new drug called REGN5381 to see if it can help adults with high blood pressure that isn't controlled by their current medications.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 732 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals (industry) |
| Locations | 3 sites (Huyton, Liverpool and 2 other locations) |
| Trial ID | NCT06833190 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an experimental drug called REGN5381 in adults with uncontrolled hypertension, meaning their blood pressure remains high despite taking one or more antihypertensive medications. The study is structured in two parts, with participants first enrolling in Part A, followed by additional enrollment in Part B. Researchers will also assess side effects, blood levels of the drug, and the body's immune response to the drug. The goal is to determine if REGN5381 can significantly reduce blood pressure in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 85 with systolic blood pressure between 130 and 180 mm Hg who are on a stable regimen of antihypertensive therapy.
Not a fit: Patients with a heart rate over 100 bpm, severe obesity, or significant liver or kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients struggling to control their high blood pressure.
How similar studies have performed: While this approach is novel, similar studies have shown promise in managing uncontrolled hypertension with new therapeutic agents.
Eligibility criteria
Show full inclusion / exclusion 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/Exclusion Criteria apply
Where this trial is running
Huyton, Liverpool and 2 other locations
- Protas, Car Park of Asda Huyton Supercentre — Huyton, Liverpool, United Kingdom (RECRUITING)
- Protas, Two New Bailey Square — Salford, Manchester, United Kingdom (RECRUITING)
- Protas, Car Park of Asda Pilsworth Road — Bury, United Kingdom (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.
Conditions: Uncontrolled Hypertension, High blood pressure, Systolic Blood Pressure