A Phase 2b, 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
- 2 期
- 状态
- 已完成
- 入组人数
- 381
- 试验地点
- 63
- 主要终点
- Percentage of Participants Who Experienced One or More Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening.
- •Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening.
- •A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention.
排除标准
- •History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria.
- •History of nephrotic syndrome.
- •History of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening.
- •Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at Screening.
- •History of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening.
- •Currently participating in or has previously participated in an interventional clinical study within 3 months before Screening.
- •Has moderate or greater renal insufficiency.
研究组 & 干预措施
Enclitide Chloride 6 mg
Participants will receive 6 mg of enlicitide chloride orally QD for 8 weeks
干预措施: Enclitide Chloride (Drug)
Enclitide Chloride 12 mg
Participants will receive 12 mg of enlicitide chloride orally QD for 8 weeks
干预措施: Enclitide Chloride (Drug)
Enclitide Chloride 18 mg
Participants will receive 18 mg of enlicitide chloride orally QD for 8 weeks
干预措施: Enclitide Chloride (Drug)
Enclitide Chloride 30 mg
Participants will receive 30 mg of enlicitide chloride orally QD for 8 weeks
干预措施: Enclitide Chloride (Drug)
Placebo
Participants will receive enlicitide chloride-matching placebo orally QD for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
时间窗: Up to approximately 17 Weeks
An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced at least one AE was reported.
Percentage of Participants Who Discontinued Study Intervention Due to AEs
时间窗: Up to approximately 9 Weeks
An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to AEs was reported.
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8
时间窗: Baseline and up to Week 8
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported.
次要结局
- Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8(Baseline and up to Week 8)
- Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8(Baseline and up to Week 8)
- Percentage of Participants With LDL-C Value at Goal at Week 8(Week 8)