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CompletedNCT06593600PINNACLEUpdated Jul 21, 2026

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

A Phase 2 interventional study of REGN7544 and Placebo in Postural Orthostatic Tachycardia Syndrome (POTS), sponsored by Regeneron Pharmaceuticals. Completed at 16 sites in 2 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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)
  • How the study drug affects symptoms associated with POTS
02

Conditions studied

  • Postural Orthostatic Tachycardia Syndrome (POTS)

Keywords

  • Orthostatic intolerance
03

In context

Postural Orthostatic Tachycardia Syndrome

131 studies on the registry are indexed under Postural Orthostatic Tachycardia Syndrome; 44 are open to participants now.

This study's enrollment of 82 is above the median of 36 across 98 interventional studies indexed under Postural Orthostatic Tachycardia Syndrome.

Browse Postural Orthostatic Tachycardia Syndrome studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Low Dose

    Randomized 1:1:1

    Drug: REGN7544

  • Experimental
    High Dose

    Randomized 1:1:1

    Drug: REGN7544

  • Placebo comparator
    Matching Placebo

    Randomized 1:1:1

    Drug: Placebo

Interventions

  • DrugREGN7544

    Subcutaneous (SC) administration

    Also known as: baloncibart

  • DrugPlacebo

    SC administration

06

What researchers measure

Primary outcomes

  1. Change in Heart Rate (HR) from supine to standing (DeltaHR)

    Time frame: At Day 8

  2. Change from baseline in DeltaHR-avg

    Only for Cohort B

    Time frame: At day 29

Secondary outcomes

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Through 90 Days

  2. Severity of TEAEs

    Time frame: Through 90 Days

  3. DeltaHR

    Time frame: At Day 15 and 29

  4. Supine HR

    Time frame: At Day 8, 15, and 29

  5. Standing HR

    Time frame: At Day 8, 15, and 29

  6. Supine blood pressure (BP)

    Time frame: At Day 8, 15, and 29

  7. Standing BP

    Time frame: At Day 8, 15, and 29

  8. Concentrations of REGN7544 in serum

    Time frame: Through 90 Days

  9. Occurrence of anti-drug antibodies (ADAs) to REGN7544

    Time frame: Through 90 Days

  10. Magnitude of ADAs to REGN7544

    Time frame: Through 90 Days

  11. Change from baseline in Orthostatic Symptom Domain Scores of the Living with POTS Questionnaire (LWPQ)

    Only for Cohort B

    Time frame: At day 29

07

Study locations

16 sites
  • Mercy Gilbert Medical Center
    Gilbert, Arizona 85297, United States
  • North County Neurology Associates
    Carlsbad, California 92011, United States
  • Stanford University
    Palo Alto, California 94304, United States
  • Southern California Heart Specialists
    Pasadena, California 91105, United States
  • Yale University
    New Haven, Connecticut 06511, United States
  • Innovative Research of West Florida, Inc.
    Clearwater, Florida 33756, United States
  • Indiana University Health Neuroscience Center
    Indianapolis, Indiana 46202, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Saint Luke's MidAmerica Heart Institute
    Kansas City, Missouri 64111, United States
  • New York University Langone
    New York, New York 10016, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • University of Texas Southwestern
    Dallas, Texas 75390, United States
  • University of Utah
    Salt Lake City, Utah 84108, United States
  • University of Calgary
    Calgary, Alberta T2N 4Z6, Canada
08

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06593600
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Nov 13, 2024
Primary completion
May 6, 2026
Completion
Jul 8, 2026
Last update
Jul 21, 2026

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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