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

Launched by REGENERON PHARMACEUTICALS · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying an experimental drug called REGN7544 to see how safe and effective it is for adults with Postural Orthostatic Tachycardia Syndrome (POTS). POTS is a condition that causes an unusually fast heart rate when a person stands up, often leading to symptoms like lightheadedness, fatigue, and palpitations. The researchers want to learn how the drug affects heart rate and blood pressure, any side effects that might occur, and how the body responds to the drug over time.

To participate in this study, individuals must be diagnosed with POTS and show specific symptoms, such as a significant increase in heart rate when standing up. They should have ongoing symptoms for at least three months and a body mass index (BMI) between 18 and 35. Participants can expect to be closely monitored throughout the study, including assessments of their heart rate, blood pressure, and possible side effects. This trial is currently recruiting participants, and it’s open to both men and women aged 18 to 88. If you or a loved one are considering participating, it’s important to discuss any medical history or current medications with the study team to ensure eligibility.

Gender

ALL

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