A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate in Adults With Hyperlipidemia in India
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
研究概览
简要总结
Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood.
Enlicitide (also known as enlicitide decanoate or MK-0616), the study medicine, is in a class of medicines designed to lower low-density lipoprotein cholesterol (LDL-C). LDL-C is sometimes called "bad cholesterol."
The goal of this study is to learn if enlicitide works better than placebo to lower the amount of LDL-C in a person's blood. Researchers also want to learn about the safety of enlicitide and if people tolerate it.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •The main inclusion criteria include but are not limited to the following:
- •History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), diabetes mellitus, stable angina pectoris, transient ischemic attack or symptomatic peripheral arterial disease
- •Has a low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL or ≥70 mg/dL depending on medical history
- •Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
- •If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Had a heart failure hospitalization within 3 months before Screening
- •Has unstable angina, a myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening
- •Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
- •Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
- •Has a history of nephrotic syndrome
- •Has poorly controlled diabetes mellitus
- •Has hyperthyroidism or inadequately controlled hypothyroidism
- •Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening
研究组 & 干预措施
Placebo
Participants will receive placebo orally qd for up to 24 weeks.
干预措施: Placebo (Other)
Enlicitide Decanoate
Participants will receive 20 mg enlicitide decanoate orally once daily (qd) for up to 24 weeks.
干预措施: Enlicitide Decanoate (Drug)
结局指标
主要结局
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
时间窗: Baseline and Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Number of Participants with One or More Adverse Events (AEs)
时间窗: Up to approximately 32 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants who Discontinue Study Drug Due to One or More AEs
时间窗: Up to approximately 24 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
次要结局
- Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in Non High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24(Baseline and Week 24)
- Percent Change From Baseline in Lipoprotein (a) (Lp(a)) at Week 24(Baseline and Week 24)
- Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24(Baseline and Week 24)