REGN7544 for POTS

Recruiting at 17 trial locations

Overseen By Clinical Trials Administrator

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Blood pressure medications

Disqualifiers: Hypertension, Heart failure, Cardiovascular, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called REGN7544 for individuals with POTS, a condition that increases heart rate upon standing. The study aims to determine the drug's safety, effectiveness, and impact on heart rate and blood pressure. It will also assess whether the body reacts against the drug, potentially reducing its effectiveness. Participants will receive either a low dose, a high dose, or a placebo (a look-alike pill with no active ingredient). Ideal participants have experienced symptoms like dizziness and fatigue that worsen when standing and improve when lying down for over three months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage testing.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking medications that directly affect blood volume, blood pressure, or heart rate at least 5 days before the screening visit.

Is there any evidence suggesting that REGN7544 is likely to be safe for humans?

Research has shown that REGN7544 has been tested in people before. In earlier studies, most participants tolerated REGN7544 well. Some experienced an increase in blood pressure, which then stabilized at a new level. No major side effects were reported, suggesting that the treatment is relatively safe for humans so far. As a Phase 2 trial, this study builds on earlier research that assessed basic safety. This indicates some existing evidence supports the safety of REGN7544 in people, but researchers continue to learn more about its complete safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for POTS?

Most treatments for Postural Orthostatic Tachycardia Syndrome (POTS), like beta-blockers, fludrocortisone, and midodrine, work by managing symptoms such as heart rate and blood pressure. But REGN7544 works differently, targeting the underlying mechanisms of POTS with a novel approach. Researchers are excited about REGN7544 because it potentially offers a more direct intervention through a new mechanism of action that could lead to better control of symptoms and improve patients' quality of life. Unlike the standard treatments, REGN7544 is being explored in both low and high doses, which might provide more tailored and effective options for individuals with POTS.

What evidence suggests that REGN7544 might be an effective treatment for POTS?

Research suggests that the drug REGN7544 might help treat Postural Orthostatic Tachycardia Syndrome (POTS), a condition affecting heart rate and blood pressure upon standing. Early findings indicate that this drug could manage symptoms by targeting a specific receptor involved in controlling blood volume and pressure. Initial studies have shown promise for REGN7544 as a long-lasting treatment for conditions like POTS, which involve issues with blood volume and pressure. Although more research is needed, early studies are examining how the drug affects heart rate and blood pressure, crucial concerns for people with POTS. ^{1 2 3 5 6}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with POTS who experience symptoms like lightheadedness and palpitations, which improve when lying down. Participants should have a BMI between 18-35, no blood pressure drops when standing, and no other conditions causing their symptoms. They must also see their symptoms as severe.

Inclusion Criteria

My heart rate increases by 30 BPM or more when I stand up.

My blood pressure does not drop significantly when I stand up.

I don't have any other health issues causing my rapid heartbeat when standing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of REGN7544 or placebo to assess pharmacodynamics, pharmacokinetics, safety, and tolerability

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and side effects after receiving the study drug

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• REGN7544

Trial Overview The study tests REGN7544 against a placebo to assess its safety, tolerability, and effectiveness in POTS patients. It will measure changes in heart rate/blood pressure, side effects occurrence, drug levels in the blood over time, and potential antibody development.

How Is the Trial Designed?

Group I: Low Dose Experimental Treatment 1 Intervention

Randomized 1:1:1

Group II: High Dose Experimental Treatment 1 Intervention

Randomized 1:1:1

Group III: Matching Placebo Placebo Group 1 Intervention

Randomized 1:1:1

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06593600

NCT06593600 | Study of Natriuretic Peptide Receptor 1 ... This study is researching an experimental drug called REGN7544 (called study drug). The study is focused on participants with POTS.

2. clinicaltrial.be clinicaltrial.be/en/details/451436?per_page=100&only_recruiting=0&only_eligible=0

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist... This study is researching an experimental drug called REGN7544 (called study drug). The study is focused on participants with POTS.

3. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/postural-orthostatic-tachycardia-syndrome

Postural Orthostatic Tachycardia Syndrome Clinical Trials The aims of this study will be to measure changes in postural orthostatic tachycardia syndrome (POTS) symptoms, functional disability and catastrophizing.

4. jacc.org jacc.org/doi/10.1016/S0735-1097%2825%2902833-5

PRECLINICAL DATA OF REGN7544: A FIRST-IN-CLASS ... It may serve as a long-acting treatment for hypervolemic and hypotensive disorders, such as postural orthostatic tachycardia syndrome and ...

5. research.ucalgary.ca research.ucalgary.ca/participate/phase-2-double-blind-placebo-controlled-single-dose-study-pharmacodynamics-pharmacokinetics-safety-reb24-1315

A Phase 2 Double-Blind Placebo-Controlled Single-Dose ... This is a Phase 2 study to test a single dose of a study drug called REGN7544 in people with postural orthostatic tachycardia syndrome (POTS).

6. ahajournals.org ahajournals.org/doi/abs/10.1161/circ.152.suppl_3.4359840

Abstract 4359840: A First-In-Human Phase 1 Study of the ... REGN7544 durably increased BP to a plateau (5–10 mmHg), with body weight and biomarker results suggesting increased plasma volume. These data ...