Clinical Trial

A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event

Study acronym: AZURE-Outcomes
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.
Protocol Amendment History 3 changes
notable Trial sites expanded: 1333 -> 1365 locations 2026-07-03
notable Trial sites expanded: 1264 -> 1333 locations 2026-06-04
notable Trial sites expanded: 1227 -> 1264 locations 2026-04-18
Trial Details
NCT Number NCT07000357
Lead Sponsor AstraZeneca
Conditions Cardiovascular Disease
Enrollment 15,100 participants
Start Date 2025-06-04
Primary Completion 2029-10-26 (estimated)
Study Completion 2029-10-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-02