A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 197
- 主要终点
- Change in log-transformed Lp(a) concentration from baseline at week 52
研究概览
简要总结
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.
详细描述
CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Eligible participants will be randomized after the screening period or Guideline recommended SOC implementation period (if needed) in a 2:1 ratio to subcutaneous injections of pelacarsen (TQJ230) 80 mg QM or placebo QM either to be self-administered or administered by caregiver or site personnel approximately every 30 days for up to 12 months.
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
- •Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years of age
- •Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory
- •On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines.
- •Established ASCVD disease defined as documented:
- •Coronary heart disease (CHD) and/or
- •Cerebrovascular disease (CVD) and/or
- •Peripheral arterial disease (PAD):
排除标准
- •Uncontrolled hypertension
- •Heart failure New York Heart Association (NYHA) class IV
- •History of malignancy of any organ system
- •History of hemorrhagic stroke or other major bleeding
- •Platelet count <140,000 per mm3
- •Active liver disease or hepatic dysfunction
- •Significant kidney disease
- •Pregnant or nursing women
研究组 & 干预措施
TQJ230
TQJ230 80mg QM s.c.
干预措施: TQJ230 (Drug)
Placebo
Matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in log-transformed Lp(a) concentration from baseline at week 52
时间窗: Baseline, week 52
The primary aim of the study is to demonstrate the superiority of pelacarsen to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a Lp(a) level of ≥ 125 nmo/L.
次要结局
- Incidence proportion of study discontinuations due to TEAEs(Up to 52 weeks)
- Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest(Up to 52 weeks)