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New treatment option for Cardiovascular Disease
Official title A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event
ClinicalTrials.gov ID: NCT07000357
What this study is testing
What is AZD0780?
AZD0780 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cardiovascular disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Meets one of the following:
- Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke...
- Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of...
- Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin/creatinine ratio ≥ 30 mg/g) and/or persistent eGFR \< 60 mL/min/1.73 m2. At...
- Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist
You likely can't join if
- Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to...
- Any revascularisation procedure planned within the next 3 months.
- Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography...
- Calculated eGFR \< 15 mL /min/1.73 m2 at screening.
- Any laboratory values with the following deviations at screening:
- AST or ALT \> 3 × ULN
See the full eligibility criteria
- Meets one of the following:
- Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior...
- Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L), with no prior...
- Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin/creatinine ratio ≥ 30 mg/g) and/or persistent eGFR \< 60 mL/min/1.73 m2. At least one reading must come from the medical record within the last 12...
- Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist
- Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist
- ABI \ 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance For (ii) and (iii), participants need to...
- CKD with eGFR x mL/min/1.73 m2
- Current tobacco use
- Age ≥ 65
- T2DM (if included on the less significant atherosclerosis criterion iii)
- 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...
- Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might...
- Any revascularisation procedure planned within the next 3 months.
- Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.
- Calculated eGFR \< 15 mL /min/1.73 m2 at screening.
- Any laboratory values with the following deviations at screening:
- AST or ALT \> 3 × ULN
- TBL \> 2 × ULN (except for participants with Gilbert's 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/creatinine ratio ≥ 500 mg/g
- Uncontrolled T2DM 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 of screening or planned use during the study.
- Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.
- Use of PCSK9 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, or any other...
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Alabama, United States
- Birmingham, Alabama, United States
- Dothan, Alabama, United States
- Fairhope, Alabama, United States
- Foley, Alabama, United States
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Vestavia Hills, Alabama, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Mesa, Arizona, United States
- Peoria, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Canoga Park, California, United States
+ 959 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Alabama, United States; Birmingham, Alabama, United States; Dothan, Alabama, United States; Fairhope, Alabama, United States; Foley, Alabama, United States; Huntsville, Alabama, United States and 973 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.