REGN5381 in Adult Participants With Uncontrolled Hypertension

NCT06833190 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: R5381-UHTN-2410
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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)

Conditions

Uncontrolled Hypertension

Keywords

High blood pressure; Systolic Blood Pressure (SBP)

Outcome Measures

Primary Outcomes (1)

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

  At week 12

Secondary Outcomes (13)

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

  At week 12

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

  At week 12

• Time-weighted average AOBP SBP

  Through week 12

• Time-weighted average AOBP Diastolic Blood Pressure (DBP)

  Through week 12

• AOBP SBP

  From baseline to weeks 2, 4 and 8

Study Arms (3)

REGN5381 Low Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN5381

REGN5381 High Dose

EXPERIMENTAL

Randomized as described in the protocol

Drug: REGN5381

Placebo

PLACEBO COMPARATOR

Randomized as described in the protocol

Drug: Placebo

Interventions

REGN5381 DRUG

Administered per the protocol

REGN5381 High Dose; REGN5381 Low Dose

Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with SBP ≥130 mm Hg and SBP ≤180 mm Hg at both screening and randomization visit, as described in the protocol
• ≥ 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

You may not qualify if:

• Heart rate \>100 bpm as described in the protocol
• Body mass index \>45 kg/m2 as described in the protocol
• Glomerular filtration rate (GFR) \<30 mL/min/1.73m2 at screening as described in the protocol
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN) as described in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (3)

Protas, Car Park of Asda Huyton Supercentre

Huyton, Liverpool, L36 7TX, United Kingdom

Location

Protas, Two New Bailey Square

Salford, Manchester, M3 5GS, United Kingdom

Location

Protas, Car Park of Asda Pilsworth Road

Bury, BL9 8RS, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: April 16, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

GB (3)