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

NCT06593600 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: R7544-POTS-2429
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 16

Brief 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)

Conditions

Postural Orthostatic Tachycardia Syndrome (POTS)

Keywords

Orthostatic intolerance

Outcome Measures

Primary Outcomes (1)

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

  At Day 8

Secondary Outcomes (10)

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Through 90 Days

• Severity of TEAEs

  Through 90 Days

• DeltaHR

  At Day 15 and 29

• Supine HR

  At Day 8, 15, and 29

• Standing HR

  At Day 8, 15, and 29

Study Arms (3)

Low Dose

EXPERIMENTAL

Randomized 1:1:1

Drug: REGN7544

High Dose

EXPERIMENTAL

Randomized 1:1:1

Drug: REGN7544

Matching Placebo

PLACEBO COMPARATOR

Randomized 1:1:1

Drug: Placebo

Interventions

REGN7544 DRUG

Subcutaneous (SC) administration

High Dose; Low Dose

Placebo DRUG

SC administration

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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
• During screening, a participant must score ≥3 on the Patient Global Impressions of Severity (PGIS)
• Has a body mass index between 18 and 35 kg/m2, inclusive

You may not qualify if:

• 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
• Is confined to bed more than 50% of waking hours
• 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)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (16)

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

North County Neurology Associates

Carlsbad, California, 92011, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Southern California Heart Specialists

Pasadena, California, 91105, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Indiana University Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's MidAmerica Heart Institute

Kansas City, Missouri, 64111, United States

Location

New York University Langone

New York, New York, 10016, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: November 13, 2024
• Primary Completion: April 13, 2026
• Study Completion (Estimated): July 6, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

CA (1); US (15)