Testing AZD0780 against a placebo for cardiovascular disease

Inclusion

• +ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD
• +CKD with eGFR x mL/min/1.73 m2
• +Meets one of the following:
• +Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more → with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• +Additional risk factors based on the level of the LDL-C and timing of MI or stroke:
• +o Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one of the other additional risk factors (i to viii) below.
• +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 history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):
• +(i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:
• +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 months in addition to the reading from screening
• +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 \< 0.9 or \> 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 have at least one of the additional risk factors below:
• +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 lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid).
• +Participants must achieve a stable background lipid lowering therapy \> 28 days before screening.
• +Current tobacco use