NCT07000357

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

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15,100 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	AZD0780	Participants will receive oral AZD0780 once daily
DRUG	Placebo	Participants will receive oral placebo once daily

Timeline

• Start date: 2025-06-04
• Primary completion: 2029-10-26
• Completion: 2029-10-26
• First posted: 2025-06-02
• Last updated: 2026-04-17

Locations

1,264 sites across 36 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Romania, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study