A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
- 试验地点
- 222
- 主要终点
- Number of participants with one or more adverse events (AEs)
研究概览
简要总结
This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 completed an enlicitide decanoate parent study [MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT Number pending)] per protocol (including the final assessments/procedures of their parent study)
- •Had an overall study intervention compliance ≥80% while participating in their parent study
排除标准
- •Has discontinued study intervention in their parent study
- •Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
- •Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study
研究组 & 干预措施
Enlicitide Decanoate
Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)
干预措施: Enlicitide Decanoate (Drug)
结局指标
主要结局
Number of participants with one or more adverse events (AEs)
时间窗: Up to approximately 3 years
An AE is 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 discontinue study drug due to an AE
时间窗: Up to approximately 3 years
An AE is 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 of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension Study(Baseline of the parent study and 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(Baseline of the parent study and Week 8 of this extension study)
- Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study(Baseline of the parent study and Week 8 of this extension study)
- Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study(Baseline of the parent study and Week 8 of this extension study)
- Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study(Baseline in the parent study and up to approximately 3 years in this extension study)
- Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study(Baseline in the parent study and up to approximately 3 years in this extension study)