Recruiting

PINNACLEREGN7544 for Postural Orthostatic Tachycardia Syndrome

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

REGN7544

+ Placebo

Drug
Who is being recruted

Autonomic Nervous System Diseases+5

+ Nervous System Diseases

+ Neurologic Manifestations

From 18 to 55 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorRegeneron Pharmaceuticals
Study ContactClinical Trials Administrator
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 13, 2024

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new medication called REGN7544 for individuals diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS). POTS is a condition that affects how blood flows through the body, leading to symptoms like dizziness and rapid heartbeat when standing up. The main goal of the study is to determine how safe and tolerable this medication is for patients, as well as how it affects heart rate and blood pressure. Understanding these effects is important for improving treatment options for people with POTS. Participants in the study will receive a single dose of the medication or a placebo. The study will monitor how the drug affects heart rate and blood pressure, and measure how much of the drug is present in the blood over time. Additionally, it will assess any side effects and check if the body creates antibodies against the drug, which could impact its effectiveness or cause other reactions. This information will help determine if REGN7544 can be a viable treatment option for managing POTS symptoms.

Official TitleA 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
Principal SponsorRegeneron Pharmaceuticals
Study ContactClinical Trials Administrator
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

81 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autonomic Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPrimary DysautonomiasOrthostatic IntolerancePostural Orthostatic Tachycardia Syndrome

Criteria

7 inclusion criteria required to participate
Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening:
Increase in HR ≥30 beats per minute (BPM) within 10 minutes of changing from supine to a standing position, as described in the protocol
Absence of orthostatic hypotension, defined as a decrease in systolic blood pressure (SBP) >20 mm Hg within 3 minutes of standing
Absence of other conditions explaining orthostatic tachycardia in the judgment of the investigator, as defined in the protocol
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6 exclusion criteria prevent from participating
History of hypertension or a seated SBP during screening that is >140 mm Hg
SBP during active stand (AS) test during screening, either supine or standing, that is >140 mm Hg systolic on ≥2 measurements
Increase in HR <20 BPM within 10 minutes of changing from supine to a standing position, as defined in protocol
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Randomized 1:1:1

Group II

Experimental
Randomized 1:1:1

Group III

Placebo
Randomized 1:1:1

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Recruiting

Mercy Gilbert Medical Center

Gilbert, United StatesOpen Mercy Gilbert Medical Center in Google Maps
Recruiting

North County Neurology Associates

Carlsbad, United States
Recruiting

Stanford University

Palo Alto, United States
Recruiting

Southern California Heart Specialists

Pasadena, United States
Recruiting
18 Study Centers