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
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:
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 →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.
Key Inclusion Criteria:
Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply
Randomized 1:1:1
Drug: REGN7544
Randomized 1:1:1
Drug: REGN7544
Randomized 1:1:1
Drug: Placebo
Subcutaneous (SC) administration
Also known as: baloncibart
SC administration
Change in Heart Rate (HR) from supine to standing (DeltaHR)
Time frame: At Day 8
Change from baseline in DeltaHR-avg
Only for Cohort B
Time frame: At day 29
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through 90 Days
Severity of TEAEs
Time frame: Through 90 Days
DeltaHR
Time frame: At Day 15 and 29
Supine HR
Time frame: At Day 8, 15, and 29
Standing HR
Time frame: At Day 8, 15, and 29
Supine blood pressure (BP)
Time frame: At Day 8, 15, and 29
Standing BP
Time frame: At Day 8, 15, and 29
Concentrations of REGN7544 in serum
Time frame: Through 90 Days
Occurrence of anti-drug antibodies (ADAs) to REGN7544
Time frame: Through 90 Days
Magnitude of ADAs to REGN7544
Time frame: Through 90 Days
Change from baseline in Orthostatic Symptom Domain Scores of the Living with POTS Questionnaire (LWPQ)
Only for Cohort B
Time frame: At day 29
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.
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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Postural Orthostatic Tachycardia Syndrome→
Regeneron Pharmaceuticals