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Experimental POTS drug targets racing heart in first human test

NCT ID NCT06593600

Symptom relief Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests a single dose of an experimental drug called REGN7544 in 82 people with Postural Orthostatic Tachycardia Syndrome (POTS). The goal is to see if the drug safely reduces the rapid heart rate that happens when standing up. Researchers will also check for side effects and how the drug moves through the body.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

82 people

The number who actually took part.

Started

Nov 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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 Key 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) NOTE: Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

Orthostatic Intolerance postural orthostatic tachycardia syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postural orthostatic tachycardia syndrome (POTS)

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana, 46202, United States

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297, United States

  • New York University Langone

    New York, New York, 10016, United States

  • North County Neurology Associates

    Carlsbad, California, 92011, United States

  • Saint Luke's MidAmerica Heart Institute

    Kansas City, Missouri, 64111, United States

  • Southern California Heart Specialists

    Pasadena, California, 91105, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.