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
Launched by ASTRAZENECA · May 23, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called AZD0780, which is designed to lower levels of LDL cholesterol (often referred to as "bad" cholesterol) in the blood. The trial is for adults who have a history of cardiovascular disease, like heart attacks or strokes, or those who are at high risk for these conditions. Participants must be at least 18 years old and have elevated LDL cholesterol levels, despite taking the highest tolerated doses of cholesterol-lowering medications, such as statins.
If you or a loved one decides to participate, the study will last about 56 weeks. This includes a screening phase of around 2 weeks to determine eligibility, followed by 52 weeks of treatment with either AZD0780 or a placebo (a dummy medication that looks the same but has no active ingredient). Neither participants nor researchers will know who is receiving which treatment until the study is complete. Throughout the trial, participants will be monitored for safety, and there will be a follow-up period after treatment. This study is not yet recruiting participants, but it may be an important opportunity for those struggling to manage their cholesterol levels effectively.
Gender
ALL
Eligibility criteria
- 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 be receiving a maximally tolerated lipid lowering regimen including a maximally tolerated dose of a statin.
- • 1. Participants must achieve a stable dose (\> 28 days) of lipid lowering therapies before screening.
- • 2. Participants who are judged by the treating physician not to tolerate high intensity statins (according to guidelines, typically, atorvastatin ≥ 40 mg once daily or rosuvastatin ≥ 20 mg once daily) may be included if treated with a low- or moderate intensity statin dose.
- • 3. Participants not receiving any statins must have documented intolerable side effects to at least 2 different statins, including one at the lowest standard dose or on a chronic medication that would prohibit the use of a statin (according to the prescribing information for the statin in question).
- 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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Hannover, , Germany
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Talcahuano, , Chile
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Dresden, , Germany
Hamburg, , Germany
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Delhi, , India
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Leabrook, , Australia
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Independencia, , Chile
Marianske Lazne, , Czechia
Praha Uhříněves, , Czechia
Trutnov, , Czechia
české Budějovice, , Czechia
Bad Friedrichshall, , Germany
Berlin Lichtenberg, , Germany
Nuernberg, , Germany
Stuhr, , Germany
Ami Machi, , Japan
Osaka Shi, , Japan
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Kraków, , Poland
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Malacky, , Slovakia
Vinica, , Slovakia
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Hull, , United Kingdom
Poole, , United Kingdom
Trowbridge, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported