A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy and Safety of Kylo-11 in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 68
- 主要终点
- Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
研究概览
简要总结
This is a phase 2, double-blind, randomized, placebo-controlled, multi-center, dose-finding study to evaluate the efficacy and safety of Kylo-11 administered subcutaneously compared to placebo in participants with ASCVD and elevated Lp(a).
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
- •Age 18 to 80 years
- •Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)
- •Other inclusion criteria applied per protocol.
排除标准
- •Have moderate to severe heart failure (New York Heart Association [NYHA] Functional Classification III or IV during Screening) or last known left ventricular ejection fraction <30%
- •Have uncontrolled hypertension (systolic blood pressure [SBP] ≥160 mmHg or diastolic blood pressure [DBP] ≥100 mmHg)
- •Have uncontrolled cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization
- •Have had any malignancy within 5 years prior to randomization (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma that has been successfully treated)
- •Other exclusion criteria applied per protocol.
研究组 & 干预措施
Cohort 3
Kylo-11 dose 3 or matched placebo will be administered subcutaneously
干预措施: Kylo-11 or matched placebo (Drug)
Cohort 1
Kylo-11 dose 1 or matched placebo will be administered subcutaneously
干预措施: Kylo-11 or matched placebo (Drug)
Cohort 2
Kylo-11 dose 2 or matched placebo will be administered subcutaneously
干预措施: Kylo-11 or matched placebo (Drug)
结局指标
主要结局
Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
时间窗: Baseline, Weeks 8~26
A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8\~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized.
Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
时间窗: Baseline, Weeks 8~26
A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8\~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized.
次要结局
- Percent change from baseline in time-averaged Lp(a) over Weeks 38~52(Baseline, Weeks 38~52)
- Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52(Week 26 and Week 52)
- Percent change from baseline in time-averaged Lp(a) over Weeks 38~52(Baseline, Weeks 38~52)
- Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52(Week 26 and Week 52)