2023-507795-51-00招募中3 期
Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies
NewAmsterdam Pharma B.V.225 个研究点 分布在 3 个国家目标入组 4,094 人开始时间: 2023年10月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4,094
- 试验地点
- 225
- 主要终点
- the time from Randomization to the first confirmed occurrence of any component of the composite endpoint, including the following: - CV death; - Non-fatal MI; - Non-fatal stroke; or - Non-elective coronary revascularization.
研究概览
简要总结
To evaluate the effect of obicetrapib on the risk of major adverse CV events (MACE), including CV death, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization.
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
- •Male or female and ≥18 years of age at Screening (Visit 1)
- •Have a history of ASCVD, defined by at least 1 of the following conditions: Coronary artery disease, Cerebrovascular disease, Peripheral arterial disease
- •Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid lowering diet and other lifestyle modifications, defined as follows: o A statin at a maximally tolerated stable dose; o Ezetimibe for at least 8 weeks with or without a maximally tolerated statin prior to Screening (Visit 1); o Bempedoic acid for at least 4-8 weeks in combination with a maximally tolerated statin prior to Screening (Visit 1); and/or o A PCSK9-targeted therapy alone or in combination with other lipidmodifying therapy for at least 4 stable doses prior to Screening (Visit 1); o At least 70% of the participants enrolled into this study must be taking HISs. Documentation in the eCRF of the reason why a participant is unable to take HISs is required. HISs include the following: o Atorvastatin 40 and 80 mg; and o Rosuvastatin 20 and 40 mg
- •Have a fasting serum LDL-C at Screening (Visit 1) as follows: o Have a fasting serum LDL-C ≥55 mg/dL to <100 mg/dL with at least 1 of the following risk enhancers: - Recent MI (>3 and <12 months prior to Randomization); - Type 2 diabetes mellitus; - Fasting triglycerides (TG) >150 mg/dL (>1.7 mmol/L); and/or - Fasting high density lipoprotein cholesterol <40 mg/dL (<1.0 mmol/L). OR o Have a fasting serum LDL-C ≥100 mg/dL.
- •Have fasting TG <400 mg/dL (<4.52 mmol/L) at Screening (Visit 1)
- •Have an estimated glomerular filtration rate ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1). Other protocol-defined criteria apply.
排除标准
- •Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction <30%
- •Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening (Visit 1)
- •Have been hospitalized for HF within 5 years prior to Screening (Visit 1)
- •Have had any of the following clinical events within 3 months prior to Screening (Visit 1): o Non-fatal MI; o Non-fatal stroke; o Non-elective coronary revascularization; and/or o Hospitalization for unstable angina and/or chest pain
- •Have uncontrolled severe hypertension, defined as either systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization, taken as the average of triplicate measurements. One triplicate retest will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized
- •Have a formal diagnosis of homozygous familial hypercholesterolemia
- •Have active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN); or total bilirubin >2 × ULN at Screening (Visit 1)
- •Have an HbA1c ≥10.0% or a fasting glucose ≥270 mg/dL at Screening (Visit 1);
- •Have a thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1)
- •Have a creatine kinase >3 × ULN at Screening (Visit 1)
结局指标
主要结局
the time from Randomization to the first confirmed occurrence of any component of the composite endpoint, including the following: - CV death; - Non-fatal MI; - Non-fatal stroke; or - Non-elective coronary revascularization.
the time from Randomization to the first confirmed occurrence of any component of the composite endpoint, including the following: - CV death; - Non-fatal MI; - Non-fatal stroke; or - Non-elective coronary revascularization.
次要结局
- The time from Randomization until the first confirmed occurrence of a composite of CV death, non-fatal MI, or non-fatal stroke
- The time from Randomization until the first confirmed occurrence of a composite of all-cause mortality, non-fatal MI, non-fatal stroke, or nonelective coronary revascularization
- A total event analysis, defined as the number of CV death events, and first and subsequent/recurrent events of non-fatal MIs, non-fatal strokes, and non-elective coronary revascularization from Randomization until the EOS Visit
- The time from Randomization until the first confirmed occurrence of non-fatal MI
- The time from Randomization until the first confirmed occurrence of non-elective coronary revascularization
研究者
Clinical Operations
Scientific
NewAmsterdam Pharma B.V.
研究点 (225)
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