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Clinical Trials in the UK / NCT07000123
Active, not recruiting Phase 3

A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event

NCT07000123 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-05-28
Last updated
2026-08-11

Condition(s) studied

Cardiovascular Disease

Investigational drug(s) / intervention(s)

AZD0780Placebo

AZD0780: Participants will receive daily oral dose of AZD0780

Placebo: Participants will receive daily oral dose of placebo

Study summary

This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated LDL-C. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study.

The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * ≥ 18 years of age at the time of signing the ICF * History of clinical ASCVD or at risk for a first ASCVD event: 1. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease. 2. A participant is considered at risk for a first ASCVD event if the participant has one or more of the following conditions: atherosclerotic vascular disease (≥ 50% stenosis in ≥ 2 coronary artery territories or in ≥ 2 vascular beds \[coronary, carotid, lower extremity\], diagnosed by any imaging modality), diabetes mellitus, hypertension, cigarette smoking, chronic kidney disease (moderate to severe stage), or obesity. Investigators can also use the ACC/AHA or ESC or other relevant national clinical guidelines for risk assessment to identify participants with at least moderate risk for ASCVD. * Fasting serum LDL-C by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in participants without clinical ASCVD but at risk for a first ASCVD event * Participants should receive a background lipid lowering regimen anticipated to achieve at least a \~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid). Thus, the background lipid-lowering therapy must consist of one of the following: \- A high intensity LDL lowering regimen (i) A high intensity statin regimen, as defined by country specific guidelines OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid : OR: \- A maximum tolerated statin regimen - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended. Participants must achieve a stable background lipid lowering therapy \> 28 days before screening. Exclusion criteria: * Homozygous familial hypercholesterolaemia, known diagnosis of HeFH, LDL apheresis or plasma apheresis within 12 months prior to screening, or any other underlying known disease or condition that may interfere with interpretation of the clinical study results as judged by the Investigator. * Any of the following laboratory values at screening: * Calculated eGFR \< 15 mL/min/1.73 m2 * AST or ALT \> 3 × ULN * TBL \> 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN) * Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L) * Creatine kinase \> 5 × ULN * Urine albumin-to-creatinine ratio ≥ 500 mg/g * Uncontrolled type 2 diabetes mellitus defined as HbA1C ≥ 9.5% at screening * Inadequately treated hypothyroidism defined as TSH \> 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening * Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study. * Use of gemfibrozil within 1 week prior to screening or planned use during the study. * Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks of the screening visit or planned use during the study or inclisiran within 18 months of the screening visit or planned use during the study. Any other approved PCSK-9 inhibitor use within 5 half-lives prior to the screening visit or planned use during the study.

Primary outcome measure(s)

Trial sites (404)

FacilityCityRegionStatus
Research Site Huntsville Alabama
Research Site Irondale Alabama
Research Site Mobile Alabama
Research Site Gilbert Arizona
Research Site Phoenix Arizona
Research Site Sun City West Arizona
Research Site Garden Grove California
Research Site Gardena California
Research Site Lancaster California
Research Site Lincoln California
Research Site San Diego California
Research Site San Diego California
Research Site Torrance California
Research Site West Hills California
Research Site Hamden Connecticut
Research Site Boca Raton Florida
Research Site Hallandale Florida
Research Site Hialeah Florida
Research Site Inverness Florida
Research Site Jacksonville Florida
Research Site Miami Florida
Research Site New Port Richey Florida
Research Site Orlando Florida
Research Site Pembroke Pines Florida
Research Site Seminole Florida
Research Site Tampa Florida
Research Site Atlanta Georgia
Research Site Atlanta Georgia
Research Site Decatur Georgia
Research Site Peachtree Corners Georgia
Research Site Chicago Illinois
Research Site Winfield Illinois
Research Site Evansville Indiana
Research Site Evansville Indiana
Research Site Indianapolis Indiana
Research Site Ames Iowa
Research Site El Dorado Kansas
Research Site Wichita Kansas
Research Site Owensboro Kentucky
Research Site Hammond Louisiana

+ 364 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07000123 on ClinicalTrials.gov ↗ ← All trials in the UK