Study Design
DesignRandomized, parallel-group, double-blind, placebo-controlled, dose-ranging
Randomization1:1:1:1:1
BlindingDouble-blind
Enrollment428
Duration12 weeks
Treatment Arms
Placebo Matching placebo once daily n=86
AZD0780 1mg 1mg oral once daily n=86
AZD0780 3mg 3mg oral once daily n=85
AZD0780 10mg 10mg oral once daily n=84
AZD0780 30mg 30mg oral once daily n=85
[{"id":"ldlc-change","name":"Percent change from baseline in LDL-C at Week 12","type":"PRIMARY","unit":"%","results":[{"label":"Placebo +4.1%","value":4.08,"arm_id":"placebo"},{"label":"1mg: -31.2% (placebo-corrected -35.3%)","value":-31.19,"arm_id":"azd0780-1mg","p_value":"<0.001"},{"label":"3mg: -33.8% (placebo-corrected -37.9%)","value":-33.83,"arm_id":"azd0780-3mg","p_value":"<0.001"},{"label":"10mg: -41.1% (placebo-corrected -45.2%)","value":-41.09,"arm_id":"azd0780-10mg","p_value":"<0.001"},{"label":"30mg: -46.6% (placebo-corrected -50.7%)","value":-46.62,"arm_id":"azd0780-30mg","p_value":"<0.001"}],"timepoint":"Week 12","description":"How much LDL cholesterol dropped compared to baseline. A bigger negative number means better cholesterol lowering."}]
KEY TAKEAWAY: Oral daily pill achieves ~50% LDL-C reduction (30mg dose) — competitive with injectable PCSK9 inhibitors.
Phase 3 AZURE-Outcomes (NCT07000357) started Jun 2025, 15,100 pts, event-driven MACE endpoint, est. completion Oct 2029.
Source: AZ Clinical Trials Registry, PubMed PMID 40167413