NCT07614958招募中3 期
A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on Top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk
A. Menarini International Licensing S.A.1 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2026年5月6日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 426
- 试验地点
- 1
研究概览
简要总结
This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Participants must have elevated low density lipoprotein cholesterol (LDL-C) levels despite receiving maximally tolerated lipid lowering therapy.
The primary objective is to compare the LDL-C lowering effect of OBI (a CETP inhibitor) against BPA at 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female and ≥18 years of age at Screening (Visit 1);
- •Females may be enrolled if all 3 of the following criteria are met:
- •Are not pregnant;
- •Are not breastfeeding; and
- •Do not plan to become pregnant during the study.
- •Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk;
- •Are on stable maximally tolerated lipid-modifying therapy for at least 8 weeks prior to Screening (Visit 1) as an adjunct to a lipid-lowering diet and lifestyle modifications, defined as a maximum tolerated statin dose, with or without ezetimibe and/or a monoclonal PCSK9-targeted therapy for at least 4 stable doses prior to Screening (Visit 1);
- •Have a fasting serum LDL-C at Screening (Visit 1) of ≥70 mg/dL (1.81 mmol/L) and <130 mg/dL (3.37 mmol/L);
- •Have fasting TGs <500 mg/dL (<5.7 mmol/L) at Screening (Visit 1); and
- •Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).
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%;
- •Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
- •Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization; and/or Hospitalization for unstable angina and/or chest pain.
- •Have uncontrolled severe hypertension;
- •Have a formal diagnosis of definite familial hypercholesterolemia (either homozygous or heterozygous) either through genetic testing on Dutch Lipid Network criteria, Simon Broome, or MedPed;
- •Have active liver disease;
- •Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
- •Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Screening (Visit 1);
- •Have history of full statin intolerance;
研究组 & 干预措施
Bempedoic Acid
Active Comparator
干预措施: Bempedoic Acid 180mg/Placebo Obicetrapib (Drug)
Obicetrapib
Experimental
干预措施: Obicetrapib 10 mg/Bempedoic Acid Placebo (Drug)
研究者
研究点 (1)
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