REGN5381 in Adult Participants With Uncontrolled Hypertension (NATRIX-SBP)

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Uncontrolled Hypertension

Treatments: Drug: REGN5381; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06833190

R5381-UHTN-2410

Details and patient eligibility

About

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)

Enrollment: 732 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

732 participants in 3 patient groups, including a placebo group

REGN5381 Low Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: REGN5381

REGN5381 High Dose

Experimental group

Description:

Randomized as described in the protocol

Treatment:

Drug: REGN5381

Placebo

Placebo Comparator group

Description:

Randomized as described in the protocol

Treatment:

Drug: Placebo