A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7262 as Monotherapy and When Coadministered With Enlicitide Decanoate in Adults With Elevated Lipoprotein(a)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 55
研究概览
简要总结
Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C).
The goals of this trial are to evaluate:
- if MK-7262 and enlicitide taken together work better than placebo at lowering Lp(a) and LDL-C levels in the blood
- if MK-7262 alone works better than placebo at lowering Lp(a) levels in the blood
- the safety and tolerability of taking MK-7262 and enlicitide alone and together
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:
- •Has Lp(a) ≥ 150 nmol/L
- •Is receiving an optimized and stable dose of statin for ≥ 30 days with no planned additions, dose changes, or discontinuations through the duration of the study
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH
- •Has a history of class IV heart failure, severe ventricular systolic dysfunction, uncontrolled ventricular arrhythmia, markedly prolonged corrected QT interval, untreated hypertension, or a recent coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization
- •Has human immunodeficiency virus infection, unless the infection is controlled (i.e. undetectable viral load)
- •Has an active hepatitis C virus infection or active or chronic hepatitis B virus infection
- •Has a history of nephrotic syndrome
- •Has severe renal insufficiency
- •Has received certain therapies in the prohibited timeframe as specified in the protocol
- •Has active or chronic hepatobiliary or hepatic disease
- •Has poorly controlled Type 1 or Type 2 diabetes
研究组 & 干预措施
MK-7262 monotherapy
Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
干预措施: Placebo for enlicitide (Drug)
MK-7262 + enlicitide
Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.
干预措施: MK-7262 (Drug)
Placebo
Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
干预措施: Placebo for MK-7262 (Drug)
Placebo
Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
干预措施: Placebo for enlicitide (Drug)
enlicitide monotherapy
Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
干预措施: Placebo for MK-7262 (Drug)
MK-7262 monotherapy
Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
干预措施: MK-7262 (Drug)
MK-7262 + enlicitide
Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.
干预措施: Enlicitide (Drug)
enlicitide monotherapy
Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
干预措施: Enlicitide (Drug)