REGN7544 for Low Blood Pressure from Sepsis
(ESTELLA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental drug called REGN7544 to determine its safety and effectiveness in helping patients with low blood pressure due to sepsis, a severe infection. Researchers aim to assess whether the drug can improve blood pressure and reduce the need for other medications typically used in these cases. They also monitor for any side effects and how the body reacts to the drug. The trial seeks patients hospitalized for sepsis who are not responding well to standard blood pressure treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be receiving standard medications for low blood pressure due to sepsis to participate.
Is there any evidence suggesting that REGN7544 is likely to be safe for humans?
Research has shown that REGN7544 is being tested for its effects on low blood pressure caused by sepsis. Earlier studies found that REGN7544 could raise blood pressure by 5–10 mmHg, with a steady and lasting increase. The research also suggests that the drug might help increase plasma volume, the liquid part of blood, which is important for maintaining stable blood pressure.
Regarding safety, REGN7544 is currently in a Phase 2 trial, indicating that initial human testing did not reveal major safety issues. However, the current study continues to monitor for side effects and assess how well people tolerate the drug. So far, data suggests that REGN7544 appears promising, but more information is needed to fully understand its safety for people with sepsis.12345Why do researchers think this study treatment might be promising for sepsis?
Researchers are excited about REGN7544 because it represents a novel approach to treating low blood pressure from sepsis. Unlike the standard treatments, such as vasopressors that constrict blood vessels to raise blood pressure, REGN7544 targets a different mechanism. This drug is designed to modulate the immune response, potentially addressing the root cause of sepsis-related low blood pressure rather than just managing the symptoms. If successful, REGN7544 could offer a more effective and potentially faster-acting solution for patients suffering from this critical condition.
What evidence suggests that REGN7544 might be an effective treatment for low blood pressure from sepsis?
Research has shown that REGN7544, a new drug tested in this trial, might help improve blood pressure in people with sepsis. Sepsis is a serious infection that can cause very low blood pressure. Although limited information exists about REGN7544's effectiveness in people with sepsis, it targets a part of the body involved in controlling blood pressure. Early studies on similar treatments suggest it might help by improving blood flow and reducing the need for other medications. Initial results are promising, but more research is needed to confirm its benefits and safety for people with sepsis. Participants in this trial will receive either REGN7544 or a placebo to evaluate its effectiveness.15678
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
Adults aged 18-85 hospitalized with a serious infection (sepsis) and low blood pressure despite IV fluids, who are on 1 or 2 vasopressors to maintain blood pressure. Participants must be receiving or about to receive antibiotics for the suspected infection.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either REGN7544 or placebo while hospitalized for sepsis-induced hypotension
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood pressure changes and side effects
What Are the Treatments Tested in This Trial?
Interventions
- REGN7544
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
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