Clinical trial NCT06833190: REGN5381 in Adult Participants With Uncontrolled Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Uncontrolled Hypertension
Keywords: High blood pressure
Systolic Blood Pressure (SBP)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 732
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Unattended Automated Office-Based Blood Pressure (AOBP) Systolic Blood Pressure (SBP)
timeFrame: At week 12
Secondary outcomes:
measure: Unattended AOBP SBP in stage 3 Chronic Kidney Disease (CKD) participants
timeFrame: At week 12
measure: Unattended AOBP SBP in participants on ≥3 anti-hypertensive therapies
timeFrame: At week 12
measure: Time-weighted average AOBP SBP
timeFrame: Through week 12
measure: Time-weighted average AOBP Diastolic Blood Pressure (DBP)
timeFrame: Through week 12
measure: AOBP SBP
timeFrame: From baseline to weeks 2, 4 and 8
measure: AOBP DBP
timeFrame: From baseline to weeks 2, 4, 8 and 12
measure: Mean SBP by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: At week 12
measure: Concentrations of REGN5381 in serum
timeFrame: Through week 20
measure: Occurrence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to week 23
measure: Severity of TEAEs
timeFrame: Up to week 23
measure: Occurrence of TEAEs leading to discontinuation of study drug
timeFrame: Up to week 23
measure: Occurrence of Anti-Drug Antibodies (ADAs) to REGN5381
timeFrame: Through week 20
measure: Titer of ADAs to REGN5381
timeFrame: Through week 20
Other outcomes:
Locations:
city: Huyton
country: United Kingdom
facility: Protas, Car Park of Asda Huyton Supercentre
state: Liverpool
city: Salford
country: United Kingdom
facility: Protas, Two New Bailey Square
state: Manchester
city: Bury
country: United Kingdom
facility: Protas, Car Park of Asda Pilsworth Road
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: