Postural Orthostatic Tachycardia Syndrome (POTS)Phase 2PINNACLENCT06593600
Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
A Phase 2 study testing REGN7544 in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by Regeneron Pharmaceuticals at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome (POTS)
- What is being tested?
- REGN7544
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 13 Nov 2024to 8 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
North County Neurology Associates
Carlsbad, California, 92011
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
University of Texas Southwestern
Dallas, Texas, 75390
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202
Saint Luke's MidAmerica Heart Institute
Kansas City, Missouri, 64111
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06511
New York University Langone
New York, New York, 10016
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Stanford University
Palo Alto, California, 94304
Southern California Heart Specialists
Pasadena, California, 91105
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84108
About this study
Official title: 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
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)
- How the study drug affects symptoms associated with POTS
- Being tested
- REGN7544, Placebo
- Keywords
- Orthostatic intolerance
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7544Drug
Also called baloncibart
Subcutaneous (SC) administration
PlaceboDrug
SC administration
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Randomized 1:1:1 Receives: Drug: REGN7544 |
| High Dose | Experimental | Randomized 1:1:1 Receives: Drug: REGN7544 |
| Matching Placebo | Placebo comparator | Randomized 1:1:1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate (HR) from supine to standing (DeltaHR)
Measured: At Day 8
Change from baseline in DeltaHR-avg
Only for Cohort B
Measured: At day 29
Secondary outcomes (11)
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Through 90 Days
Severity of TEAEs
Measured: Through 90 Days
DeltaHR
Measured: At Day 15 and 29
Supine HR
Measured: At Day 8, 15, and 29
Standing HR
Measured: At Day 8, 15, and 29
Supine blood pressure (BP)
Measured: At Day 8, 15, and 29
Standing BP
Measured: At Day 8, 15, and 29
Concentrations of REGN7544 in serum
Measured: Through 90 Days
Occurrence of anti-drug antibodies (ADAs) to REGN7544
Measured: Through 90 Days
Magnitude of ADAs to REGN7544
Measured: Through 90 Days
Change from baseline in Orthostatic Symptom Domain Scores of the Living with POTS Questionnaire (LWPQ)
Only for Cohort B
Measured: At day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 Nov 2024
- Primary completion6 May 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Orthostatic Tachycardia Syndrome (POTS)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593600
- Sponsor's protocol ID
- R7544-POTS-2429
- Acronym
- PINNACLE
- Status last verified
- Jul 2026
- First submitted
- 9 Sep 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06593600
- Acronym / sponsor ID
- PINNACLE / R7544-POTS-2429
- Keywords
- Orthostatic intolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- How the study drug affects symptoms associated with POTS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: REGN7544Randomized 1:1:1 |
| High Dose | Experimental | Drug: REGN7544Randomized 1:1:1 |
| Matching Placebo | Placebo comparator | Drug: PlaceboRandomized 1:1:1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening:
- 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 exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN7544Also: baloncibartSubcutaneous (SC) administration | Drug | High Dose, Low Dose |
| PlaceboSC administration | Drug | Matching Placebo |
Primary outcome
Change in Heart Rate (HR) from supine to standing (DeltaHR)
Time frame: At Day 8
Change from baseline in DeltaHR-avg
Time frame: At day 29
Only for Cohort B
11 secondary outcomes
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)
Time frame: At day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REGN7544 in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by Regeneron Pharmaceuticals at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate (HR) from supine to standing (DeltaHR) (time frame: At Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.