2025-520521-21-00招募中3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 780
- 试验地点
- 155
- 主要终点
- Relative change in LDL-C from baseline to 12 weeks
研究概览
简要总结
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age at the time of signing the ICF
- •History of clinical ASCVD or at risk for a first ASCVD event: (a) Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease. (b) 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.
排除标准
- •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 m^2 (CKD-EPI formula; Delgado et al 2022, Inker et al 2021) 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 > 5X 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.
结局指标
主要结局
Relative change in LDL-C from baseline to 12 weeks
Relative change in LDL-C from baseline to 12 weeks
次要结局
- Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks
- 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
- 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
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (155)
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