*AZURE-LDL

• Research type

  Research Study

• Full title

  A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Elevated Low-Density Lipoprotein Cholesterol and Clinical Atherosclerotic Cardiovascular Disease or at Risk for a First Atherosclerotic Cardiovascular Disease Event

• IRAS ID

  1011704

• Contact name

  Emma Greening

• Contact email

  ukregulatoryaffairs@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Research summary

  Background and Purpose: Researchers are looking for better ways to treat high levels of low-density lipoprotein cholesterol (LDL), which is a type of “bad” cholesterol that can clog the arteries. Atherosclerotic cardiovascular disease (ASCVD) is caused by a buildup of LDL and plaques in the arteries that can reduce or block blood flow to important organs. Having high LDL cholesterol increases the risk of having an ASCVD event like a heart attack or stroke.
  The trial drug AZD0780 is designed to block the PCSK9 protein, which could help people with high LDL cholesterol and with ASCVD or who are at risk of having an ASCVD event for the first time. Researchers want to learn if AZD0780 lowers LDL cholesterol and levels of other types of fats and proteins compared to a placebo and how safe it is. The placebo looks like AZD0780 but does not contain any medicine.
  Design: This is a Phase 3, randomized, double-blind, placebo-controlled trial. Randomized means that a computer program will randomly assign the treatment each participant takes. Double-blind means none of the participants or study team will know what treatment each participant receives. Placebo-controlled means that some participants will receive placebo.
  Population: This trial will include about 2,800 participants who are at least 18 years old, with high LDL cholesterol, with ASCVD or at risk for a first ASCVD event. Participants must be taking at least 1 other medication, such as statin, to help lower their cholesterol.
  Treatments and Procedures: Participants will be randomly assigned to take once a day the AZD0780 or placebo, as tablets by mouth, for 52 weeks (approximately 1 year).
  To monitor the participants’ health throughout the trial, they will have:
  ► Blood and urine tests
  ► Physical exams
  ► Vital sign checks ► Heart function tests using an electrocardiogram (ECG)
  ► To report medications and any medical problems

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  25/LO/0223

• Date of REC Opinion

  4 Jun 2025

• REC opinion

  Further Information Favourable Opinion