A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,912
- 试验地点
- 336
- 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
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
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
- •Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
- •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
- •Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
- •Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
- •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 without adequate washout
研究组 & 干预措施
Enlicitide Decanoate
Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
干预措施: Enlicitide Decanoate (Drug)
Placebo
Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
干预措施: Placebo (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 ~60 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 an AE
时间窗: Up to ~52 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.
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
时间窗: Baseline and Week 24
Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C.
Number of Participants With One or More Adverse Events (AEs)
时间窗: Up to 60 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 Discontinued Study Drug Due to an AE
时间窗: Up to 52 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
- Mean percent change from baseline in LDL-C at Week 52(Baseline and Week 52)
- 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)
- Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24(Baseline and Week 24)
- Percent Change From Baseline in Lipoprotein(a) (Lp(a)) at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in LDL-C at Week 52(Baseline and Week 52)
- 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)
- Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24(Baseline and Week 24)
- Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24(Baseline and Week 24)