Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
- Conditions
- Postural Orthostatic Tachycardia Syndrome (POTS)
- Interventions
- Drug: Placebo
- Registration Number
- NCT06593600
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 81
-
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
Key
- 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)
NOTE: Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose REGN7544 Randomized 1:1:1 High Dose REGN7544 Randomized 1:1:1 Matching Placebo Placebo Randomized 1:1:1
- Primary Outcome Measures
Name Time Method Change in Heart Rate (HR) from supine to standing (DeltaHR) At Day 8
- Secondary Outcome Measures
Name Time Method 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 Supine blood pressure (BP) At Day 8, 15, and 29 Standing BP At Day 8, 15, and 29 Concentrations of REGN7544 in serum Through 90 Days Incidence of anti-drug antibodies (ADAs) to REGN7544 Through 90 Days Titer of ADAs to REGN7544 Through 90 Days
Trial Locations
- Locations (14)
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
North County Neurology Associates
🇺🇸Carlsbad, 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
Saint Luke's MidAmerica Heart Institute
🇺🇸Kansas City, Missouri, United States
New York University Langone
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada