REGN7544 for POTS

Recruiting at 10 trial locations

Overseen By Clinical Trials Administrator

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Blood pressure medications

Disqualifiers: Hypertension, Heart failure, Cardiovascular, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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)

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.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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

Key

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

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

Trial Timeline

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

Treatment Details

Interventions

• REGN7544 (Natriuretic Peptide Receptor Antagonist)

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.

Participant Groups

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