A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 59
- 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 heterozygous familial 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 possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
- •Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
- •Is treated with a moderate- or high-intensity statin medication
- •Is on a stable dose of all background lipid-lowering therapies (LLTs) 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
研究组 & 干预措施
Enlicitide Decanoate
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
干预措施: Enlicitide Decanoate (Drug)
Placebo
Participants received 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 were collected at baseline and at Week 24 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Number of Participants With Adverse Events (AEs)
时间窗: Up to 64 weeks (8 weeks postdose)
An AE was defined as 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 56 weeks
An AE was defined as 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 (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)