NCT06593600

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

A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of REGN7544, an NPR1 Antagonist Monoclonal Antibody, in Patients With Postural Orthostatic Tachycardia Syndrome

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	REGN7544	Subcutaneous (SC) administration
DRUG	Placebo	SC administration

Timeline

• Start date: 2024-11-13
• Primary completion: 2026-03-20
• Completion: 2026-06-11
• First posted: 2024-09-19
• Last updated: 2026-02-10

Locations

18 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study