Loading clinical trials...

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)

A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of REGN7544, an NPR1 Antagonist Monoclonal Antibody, in Patients With Postural Orthostatic Tachycardia Syndrome

NCT06593600•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on participants with POTS. The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: * How the study drug changes heart rate and blood pressure in participants with POTS * 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 study drug less effective or could lead to side effects)

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening:
•1. Increase in HR ≥30 beats per minute (BPM) within 10 minutes of changing from supine to a standing position, as described in the protocol
•2. Absence of orthostatic hypotension, defined as a decrease in systolic blood pressure (SBP) \>20 mm Hg within 3 minutes of standing
•3. Absence of other conditions explaining orthostatic tachycardia in the judgment of the investigator, as defined in the protocol
•4. Ongoing episodic symptoms consistent with POTS (for example, lightheadedness, palpitations, tremulousness, generalized weakness, blurred vision, and fatigue) that are worse with standing and are relieved by lying down and which have been present for ≥3 months
•2. During screening, a participant must score ≥3 on the Patient Global Impressions of Severity (PGIS)
•3. Has a body mass index between 18 and 35 kg/m2, inclusive

Exclusion Criteria

•1. History of hypertension or a seated SBP during screening that is \>140 mm Hg
•2. SBP during active stand (AS) test during screening, either supine or standing, that is \>140 mm Hg systolic on ≥2 measurements
•3. Increase in HR \<20 BPM within 10 minutes of changing from supine to a standing position, as defined in protocol
•4. Is judged by the investigator to have significant heart failure, cardiovascular disease, liver disease, or renal disease (ie, estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2) based on medical history, physical exam, laboratory studies, and/or electrocardiogram (ECG) performed during screening period
•5. Is confined to bed more than 50% of waking hours
•6. Within 5 days of screening visit has used medications with direct effects on blood volume, BP, or HR (eg, midodrine, droxidopa, octreotide, clonidine, methyldopa, ivabradine, beta-blockers, calcium channel blockers, pyridostigmine, fludrocortisone, desmopressin, stimulants or intravenous (IV) saline)

Locations (18)

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

North County Neurology Associates

Carlsbad, California, United States

Stanford University

Palo Alto, California, United States

Southern California Heart Specialists

Pasadena, California, United States

Yale University

New Haven, Connecticut, United States

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Indiana University Health Neuroscience Center

Indianapolis, Indiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's MidAmerica Heart Institute

Kansas City, Missouri, United States

Key Dates

Start Date

November 13, 2024

Primary Completion Date

March 20, 2026

Completion Date

June 11, 2026

Last Updated

February 10, 2026

Enrollment

ESTIMATED participants

Conditions

Postural Orthostatic Tachycardia Syndrome (POTS)

Interventions

REGN7544

DRUG

Placebo

DRUG

Contacts

Clinical Trials Administrator

CONTACT

844-734-6643 clinicaltrials@regeneron.com

Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome

NCT06936319

Postural Orthostatic Tachycardia Syndrome (POTS)

View study

NOT_YET_RECRUITINGNA

aVNT in POTS - Pilot

NCT07026643

Postural Orthostatic Tachycardia Syndrome (POTS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions