A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of DII235 in Adults With Elevated Lipoprotein(a)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 234
- 试验地点
- 87
- 主要终点
- Time averaged percentage change from baseline between Day 60 and Day 180
研究概览
简要总结
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(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)
盲法说明
In order to preserve the integrity of the study and to minimize bias, a randomized double-blind study design is being used.
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
- •Signed informed consent must be obtained prior to participation in the study.
- •Male or female participants 18 to 80 years of age (inclusive) at the screening.
- •Lp(a) ≥ 150 nmol/L at screening, measured at the central laboratory.
- •Participants with evidence of atherosclerotic cardiovascular disease and/or type 2 diabetes mellitus.
排除标准
- •Severe renal dysfunction
- •Hepatic dysfunction
- •Malignancy within the last 5 years
- •Use of investigational medications as defined in the protocol
- •History or presence at screening of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the Investigator, or sponsor if consulted, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Arm 2
DII235 dose 1
干预措施: DII235 (Drug)
Arm 3
DII235 dose 2
干预措施: DII235 (Drug)
Arm 1
Placebo
干预措施: Saline (Drug)
Arm 4
DII235 dose 3
干预措施: DII235 (Drug)
Arm 5
DII235 dose 4
干预措施: DII235 (Drug)
结局指标
主要结局
Time averaged percentage change from baseline between Day 60 and Day 180
时间窗: baseline to day 60 and day 180
Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 180, defined as the area under the curve (AUC) between the Day 60 Visit date and the Day 180 Visit date, divided by the duration between the two visit dates.
Difference between DII235 dose 2 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360
时间窗: baseline to day 60 and day 360
Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates.
Difference between DII235 dose 4 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360
时间窗: baseline to day 60 and day 360
Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates.
次要结局
- Difference between DII235 dose 1, dose 3 and placebo versus placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360(baseline to day 60 and 360)
- Difference between DII235 doses versus placebo in time-averaged percent change from baseline in Lp(a) measured between Day 240 and Day 360(baseline to day 240 and Day 360)
- Difference between DII235 doses versus placebo with respect to the proportion of participants in achieving Lp(a) < 125 nmol/L at Day 180 and Day 360(Day 180 and Day 360)
- Difference between DII235 doses versus placebo with respect to the proportion of participants in achieving Lp(a) < 75 nmol/L at Day 180 and Day 360(Day 180 and Day 360)