REGN5381 in Adult Participants With Uncontrolled Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-16

Study Completion Date

2025-10-15

Brief Summary

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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)

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Detailed Description

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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

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Uncontrolled Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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REGN5381 Low Dose

Randomized as described in the protocol

Group Type EXPERIMENTAL

REGN5381

Intervention Type DRUG

Administered per the protocol

REGN5381 High Dose

Randomized as described in the protocol

Group Type EXPERIMENTAL

REGN5381

Intervention Type DRUG

Administered per the protocol

Placebo

Randomized as described in the protocol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered per the protocol

Interventions

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REGN5381

Administered per the protocol

Intervention Type DRUG

Placebo

Administered per the protocol

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No