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Study of REGN7544 for Treating Adults with Low Blood Pressure Caused by Sepsis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as sepsis-induced hypotension, which occurs when a severe infection leads to dangerously low blood pressure. The study will evaluate a treatment using a medication called REGN7544, which is a type of protein designed to help manage this condition. REGN7544 is administered as a solution for injection through an intravenous infusion, meaning it is delivered directly into the bloodstream.

The purpose of the study is to assess how well REGN7544 can reduce the need for medications called vasopressors, which are used to raise blood pressure in patients with sepsis-induced hypotension. Participants in the study will receive either REGN7544 or a placebo, and the effects on their blood pressure and overall health will be monitored. The study will also look at the safety of REGN7544 and how the body processes the medication.

Throughout the study, researchers will collect information on various health indicators, such as blood pressure levels and the amount of vasopressors needed. They will also monitor for any side effects and measure the levels of REGN7544 in the blood. The study aims to provide valuable insights into the potential benefits of REGN7544 for patients with sepsis-induced hypotension.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to receive either the REGN7544 medication or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  2. Step 2

    Treatment administration

    Participants receive the assigned treatment through an intravenous infusion. The medication, REGN7544, is a solution for injection. The frequency and duration of administration are determined by the study protocol.

  3. Step 3

    Monitoring and assessment

    Throughout the study, participants are monitored for changes in blood pressure and the need for vasopressors, which are medications that help maintain blood pressure. The primary focus is on the cumulative dose of vasopressors required.

    Secondary assessments include monitoring for any adverse events, changes in blood pressure from baseline, and the proportion of participants who no longer need vasopressors.

  4. Step 4

    Data collection

    Data is collected on various parameters, including fluid balance, urine output, and fluid intake. Blood samples are taken to measure the concentration of REGN7544 in the serum and to check for the presence of anti-drug antibodies.

  5. Step 5

    Study completion

    The study is estimated to conclude by April 12, 2026. Participants will have completed all required assessments and data collection by this time.

Who can join the trial?

4 criteria

  • The patient must have a proven or suspected infection, which means they are receiving or planning to receive antibiotics during the screening period.
  • The patient must have **sepsis-induced hypotension**, which is low blood pressure caused by a severe infection. This condition should not have improved with intravenous (IV) fluids. The patient should be receiving 1 or 2 **vasopressors** (medications that help raise blood pressure) and maintain a **Mean Arterial Pressure (MAP)** of at least 65 mm Hg for at least 2 consecutive hours right before being chosen for the study.
  • Other criteria defined in the study protocol must also be met.
  • Both male and female patients can participate.

Who cannot join the trial?

3 criteria

  • Participants who do not have sepsis-induced hypotension. This means a drop in blood pressure caused by a severe infection.
  • Participants who are not within the specified age range for the study.
  • Participants who belong to a vulnerable population, which means groups that may need special protection or care.
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Investigated drugs

REGN7544 is a monoclonal antibody designed to target and block the activity of a specific protein called NPR1. This medication is being studied for its potential to help patients with sepsis-induced hypotension, a condition where blood pressure drops dangerously low due to a severe infection. By blocking NPR1, REGN7544 may help stabilize blood pressure and reduce the need for other medications that raise blood pressure, known as vasopressors.

What is already known about the treatment

REGN7544 – This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating sepsis-induced hypotension. It is a monoclonal antibody that works by blocking the NPR1 receptor, which plays a role in blood pressure regulation. The main goal of this medication is to reduce the need for vasopressors, which are drugs that help raise blood pressure in patients with sepsis. REGN7544 is classified as an antagonist monoclonal antibody, and its development is focused on improving outcomes for patients experiencing dangerously low blood pressure due to sepsis.

Investigated diseases

Sepsis-Induced Hypotension – This condition occurs when a severe infection leads to a significant drop in blood pressure, which can cause inadequate blood flow to organs. It is a complication of sepsis, where the body's response to infection causes widespread inflammation. As the condition progresses, the blood vessels may become leaky, and the heart may not pump effectively, leading to further drops in blood pressure. This can result in reduced oxygen delivery to tissues and organs, potentially causing organ dysfunction. The body may attempt to compensate by increasing heart rate and constricting blood vessels, but these mechanisms can be overwhelmed. Monitoring and managing blood pressure is crucial to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514946-35-00Protocol codeR7544-SIH-2435Estimated enrolment76 patientsSponsorRegeneron Pharmaceuticals Inc.

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