NCT06833190

REGN5381 in Adult Participants With Uncontrolled Hypertension

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DRUG	REGN5381	Administered per the protocol
DRUG	Placebo	Administered per the protocol

Timeline

• Start date: 2025-04-16
• Primary completion: 2025-10-15
• Completion: 2025-10-15
• First posted: 2025-02-18
• Last updated: 2025-10-23

Locations

3 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study