2023-504922-20-00招募中3 期
A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 583
- 试验地点
- 43
- 主要终点
- Number of participants with one or more adverse events (AEs)
研究概览
简要总结
To evaluate the safety and tolerability of enlicitide treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Has completed an enlicitide (also known as enlicitide decanoate and MK-0616) parent study (MK-0616-013, MK-0616-017, MK-0616-018) per protocol including the final assessments/procedure of their parent study
- •Had overall study compliance ≥80% while participating in their parent study
排除标准
- •Had discontinued study intervention in their parent study
- •Has an ongoing serious adverse event (SAE) considered related to study intervention by the investigator in the parent study
- •Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
- •Is currently participating in an interventional clinical study other than an enlicitide parent study (i.e., MK-0616-013, MK-0616-017, MK-0616-018)
结局指标
主要结局
Number of participants with one or more adverse events (AEs)
Number of participants with one or more adverse events (AEs)
Number of participants who discontinue study drug due to an AE
Number of participants who discontinue study drug due to an AE
次要结局
- Percent change from baseline of the parent study in low-density lipoprotein cholesterol (LDL-C) at Week 8 of this extension study
- Percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this extension study
- Percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study
- Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study
- Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study
- Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study
研究者
Laura Gellis
Scientific
Merck Sharp & Dohme LLC
研究点 (43)
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