AZD0780 for Cardiovascular Disease
(AZURE-Outcomes Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new oral medication, AZD0780, which aims to lower the risk of serious heart-related events in individuals with cardiovascular issues. The trial compares AZD0780 to a placebo (a pill without active medicine) to determine its effectiveness in reducing these risks. Individuals who have experienced heart problems or are at high risk, such as those undergoing ongoing diabetes treatment or with a history of artery disease, may be suitable candidates. Participants should already be on a stable dose of cholesterol-lowering medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial requires participants to be on a stable dose of their current lipid-lowering medications, including statins, for at least 28 days before screening. Some specific medications, like certain PCSK9 inhibitors and cholesterol-lowering drugs, must be stopped before joining the trial.
Is there any evidence suggesting that AZD0780 is likely to be safe for humans?
Research has shown that AZD0780, a pill that helps lower cholesterol, has been tested in several studies for its safety and effectiveness. Participants in these studies generally tolerated the treatment well. One study found that AZD0780 reduced LDL cholesterol (the "bad" cholesterol) by 51% and was mostly safe for participants.
Some side effects were reported, but they were not severe for most people. This treatment is now in an advanced testing stage, indicating it has already passed earlier safety tests in people. This suggests that AZD0780 is generally safe for human use, but ongoing studies aim to confirm its safety and effectiveness further.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for cardiovascular disease, which usually focus on managing symptoms and preventing progression through drugs like statins or beta-blockers, AZD0780 offers a novel approach. Researchers are excited about AZD0780 because it targets a new pathway linked directly to the underlying causes of cardiovascular issues, potentially addressing the root problem rather than just the symptoms. This new mechanism of action could lead to more effective management of cardiovascular diseases, offering hope for better outcomes and improved quality of life for patients.
What evidence suggests that AZD0780 might be an effective treatment for cardiovascular disease?
Research has shown that AZD0780, a pill that blocks a protein called PCSK9, holds promise for lowering heart-related risks. In one study, 84% of participants taking AZD0780 reached cholesterol targets set by heart health experts. Earlier studies found it compared well to other PCSK9 blockers, which effectively lower LDL cholesterol, often called "bad" cholesterol. This trial will compare AZD0780 to a placebo to evaluate its potential in reducing major heart problems in people with heart disease or those at high risk. The treatment has generally proven safe to use.24678
Are You a Good Fit for This Trial?
This trial is for patients with a history of cardiovascular disease or at high risk for their first event. Participants must meet specific health criteria to join, but the provided information does not detail these requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral AZD0780 or placebo once daily to assess the effect on reducing the risk of MACE-PLUS
Follow-up
Participants are monitored for safety and effectiveness after treatment until the Study Closure Visit
What Are the Treatments Tested in This Trial?
Interventions
- AZD0780
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology