Available in Chile, Brazil, Argentina, United States
This is a randomised, double-blind, placebo-controlled, parallel-group Phase III study to
evaluate the effect on the reduction of LDL-C and the safety and tolerability of AZD0780
versus placebo, administered as xx mg once daily orally, on top of maximally tolerated
lipid-lowering regimen including maximally tolerated statin therapy. The target
population is adults ≥ 18 years of age with LDL-C ≥ 55 mg/dL and history of clinical
ASCVD or ≥ 70 mg/dL and at risk for a first ASCVD event.
The study will be conducted at approximately 470 centres in approximately 21 countries.
The screening period is up to 14 days (and may be conditionally extended), starts at the
date of signed informed consent, and ends on the day before the randomisation visit.
Participants will be randomised in a 1:1 ratio to either AZD0780 or placebo for a
treatment period of 52 weeks and a 10-day safety follow-up. Those randomised to the
AZD0780 group will receive AZD0780 xx mg orally once daily during the treatment period,
while those in the placebo group will receive matching placebo. The study will include
approximately 2800 randomised participants. An independent data monitoring committee
will, on a regular basis, review accumulating data from the study, evaluate adverse
effects of the IMP, and make recommendations regarding whether to halt or modify the
study.
2800Patients around the world