A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 35
- 主要终点
- Mean Percent Change from Baseline in LDL-C at Day 56
研究概览
简要总结
The main purpose of this study is to assess whether enlicitide decanoate is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide decanoate is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.
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 either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event
- •Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C ≥55 mg/dL (≥1.42 mmol/L) OR b) No history of a major ASCVD event with LDL-C ≥70 mg/dL (≥1.81 mmol/L)
- •Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy [LLT])
- •Is on a stable dose of all background LLTs with no planned medication or dose changes during the study
- •Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent
排除标准
- •Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH
- •Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction ≤25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening)
- •Participants with a history of tendon disorder or tendon rupture
- •Participants with a history of gout
- •Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
- •Was previously treated/is being treated with certain other cholesterol lowering medications, including ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
研究组 & 干预措施
Ezetimibe + Bempedoic Acid
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide decanoate-matching placebo orally QD for approximately 56 days.
干预措施: Ezetimibe (Drug)
Enlicitide Decanoate
Participants receive enlicitide decanoate 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
干预措施: Enlicitide Decanoate (Drug)
Enlicitide Decanoate
Participants receive enlicitide decanoate 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
干预措施: Placebo for Ezetimibe (Other)
Enlicitide Decanoate
Participants receive enlicitide decanoate 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
干预措施: Placebo for Bempedoic Acid (Other)
Ezetimibe
Participants receive ezetimibe 10mg, enlicitide decanoate-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
干预措施: Ezetimibe (Drug)
Ezetimibe
Participants receive ezetimibe 10mg, enlicitide decanoate-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
干预措施: Placebo for Enlicitide Decanoate (Other)
Ezetimibe
Participants receive ezetimibe 10mg, enlicitide decanoate-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
干预措施: Placebo for Bempedoic Acid (Other)
Bempedoic Acid
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide decanoate-matching placebo QD orally up to approximately 56 days.
干预措施: Bempedoic Acid (Drug)
Bempedoic Acid
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide decanoate-matching placebo QD orally up to approximately 56 days.
干预措施: Placebo for Enlicitide Decanoate (Other)
Bempedoic Acid
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide decanoate-matching placebo QD orally up to approximately 56 days.
干预措施: Placebo for Ezetimibe (Other)
Ezetimibe + Bempedoic Acid
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide decanoate-matching placebo orally QD for approximately 56 days.
干预措施: Bempedoic Acid (Drug)
Ezetimibe + Bempedoic Acid
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide decanoate-matching placebo orally QD for approximately 56 days.
干预措施: Placebo for Enlicitide Decanoate (Other)
结局指标
主要结局
Mean Percent Change from Baseline in LDL-C at Day 56
时间窗: Baseline and Day 56
Blood samples will be collected at baseline and after 56 days of treatment to assess mean percentage change in LDL-C. The percent change from baseline in LDL-C at Day-56 will be reported.
次要结局
- Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Day 56(Baseline and Day 56)
- Mean Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Day 56(Baseline and Day 56)
- Percentage of Participants Who at Day 56 Have an LDL-C <70 mg/dL and ≥50% Reduction from Baseline(Baseline and Day 56)
- Percentage of Participants Who at Day 56 Have an LDL-C <55 mg/dL and ≥50% Reduction from Baseline(Baseline and Day 56)
- Number of Participants With ≥1 Adverse Event (AE)(Up to Approximately 112 days)
- Percent Change from Baseline in Lipoprotein(a) Levels (Lp[a])(Baseline and Day 56)
- Number of Participants Discontinuing from Study Therapy Due to AE(Up to Approximately 56 days)