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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520521-21-00
Acronym
D7960C00012
Enrollment
780
Registered
2025-08-18
Start date
2025-09-02
Completion date
Unknown
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic cardiovascular disease, Hyperlipidemia

Brief summary

Relative change in LDL-C from baseline to 12 weeks

Detailed description

Relative change in LDL-C from baseline to 12 weeks (in patients on background statin therapy at baseline), Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks, Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks, Relative change in LDL-C from baseline to 28 weeks, Relative change in LDL-C from baseline to 52 weeks, Relative change in Apo B from baseline to 12 weeks, Relative change in non-HDL-C from baseline to 12 weeks, Relative change in total cholesterol from baseline to 12 weeks, Relative change in Lp(a) from baseline to 12 weeks

Interventions

DRUGAZD0780 Placebo
DRUGAZD0780

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Relative change in LDL-C from baseline to 12 weeks—

Secondary

MeasureTime frame
Relative change in LDL-C from baseline to 12 weeks (in patients on background statin therapy at baseline), Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks, Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks, Relative change in LDL-C from baseline to 28 weeks, Relative change in LDL-C from baseline to 52 weeks, Relative change in Apo B from baseline to 12 weeks, Relative change in non-HDL-C from baseline to 12 weeks, Relative change in total cholesterol from baseline to 12 weeks, Relative change in Lp(a) from baseline to 12 weeks—

Countries

Bulgaria, Czechia, Germany, Hungary, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026