REGN5381 in Adult Participants With Uncontrolled Hypertension

Phase 2

Recruiting

• Conditions: Uncontrolled Hypertension
• Interventions: Drug: REGN5381; Drug: Placebo

• Registration Number: NCT06833190
• Lead Sponsor: Regeneron Pharmaceuticals

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

Not available

Study Timeline

• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Study Start: 2025-04-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-05-08
• Study Completion: 2026-07-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 732

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REGN5381 Low Dose	REGN5381	Randomized as described in the protocol
REGN5381 High Dose	REGN5381	Randomized as described in the protocol
Placebo	Placebo	Randomized as described in the protocol

Primary Outcome Measures

Name	Time	Method
Unattended Automated Office-Based Blood Pressure (AOBP) Systolic Blood Pressure (SBP)	At week 12

Secondary Outcome Measures

Name	Time	Method
Unattended AOBP SBP in stage 3 Chronic Kidney Disease (CKD) participants	At week 12
Mean SBP by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	At week 12
Concentrations of REGN5381 in serum	Through week 20
Unattended AOBP SBP in participants on ≥3 anti-hypertensive therapies	At week 12
AOBP SBP	From baseline to weeks 2, 4 and 8
Time-weighted average AOBP SBP	Through week 12
AOBP DBP	From baseline to weeks 2, 4, 8 and 12
Time-weighted average AOBP Diastolic Blood Pressure (DBP)	Through 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

Trial Locations

Locations (3)

Protas, Car Park of Asda Pilsworth Road; 🇬🇧 Bury, United Kingdom

Protas, Car Park of Asda Huyton Supercentre; 🇬🇧 Huyton, Liverpool, United Kingdom

Protas, Two New Bailey Square; 🇬🇧 Salford, Manchester, United Kingdom