REGN5381 in Adult Participants With Uncontrolled Hypertension

Phase 2TerminatedNCT06833190

Regeneron Pharmaceuticals34 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Uncontrolled Hypertension

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (3)

Protas, Car Park of Asda Huyton Supercentre

Huyton, Liverpool, United Kingdom

Protas, Two New Bailey Square

Salford, Manchester, United Kingdom

Protas, Car Park of Asda Pilsworth Road

Bury, United Kingdom

Outcomes

Primary Outcomes

Unattended Automated Office-Based Blood Pressure (AOBP) Systolic Blood Pressure (SBP)

Time frame: At week 12

Secondary Outcomes

Unattended AOBP SBP in stage 3 Chronic Kidney Disease (CKD) participants

Time frame: At week 12

Unattended AOBP SBP in participants on ≥3 anti-hypertensive therapies

Time frame: At week 12

Time-weighted average AOBP SBP

Time frame: Through week 12

Time-weighted average AOBP Diastolic Blood Pressure (DBP)

Time frame: Through week 12

AOBP SBP

Time frame: From baseline to weeks 2, 4 and 8

AOBP DBP

Time frame: From baseline to weeks 2, 4, 8 and 12

Mean SBP by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Time frame: At week 12

Concentrations of REGN5381 in serum

Time frame: Through week 20

Occurrence of Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to week 23

Severity of TEAEs

Time frame: Up to week 23

Occurrence of TEAEs leading to discontinuation of study drug

Time frame: Up to week 23

Occurrence of Anti-Drug Antibodies (ADAs) to REGN5381

Time frame: Through week 20

Titer of ADAs to REGN5381

Time frame: Through week 20