2024-516356-18-00招募中3 期
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) with background inclisiran in participants with atherosclerotic cardiovascular disease, and elevated LDL-C and Lp(a)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 45
- 主要终点
- Change in log-transformed Lp(a) concentration from baseline at Month 6
研究概览
简要总结
Evaluate the efficacy of pelacarsen compared to placebo, in reducing Lp(a) levels at Month 6 in ASCVD participants who have elevated Lp(a), and who are on background inclisiran for elevated LDL-C.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female participants 18 to ≤80 years of age at Screening visit
- •Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
- •On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
- •Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
- •On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
- •Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
- •Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit
排除标准
- •Prior treatment with inclisiran
- •Significant kidney disease at Screening visit
- •Pregnant or nursing women at Screening visit
- •Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit
- •Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
- •Uncontrolled hypertension at Randomization/Baseline visit
- •Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
- •Triglycerides ≥400 mg/dL at Screening visit
- •History of malignancy of any organ system within the past 5 years
- •Myocardial infarction, stroke or other major bleeding, coronary or lower limb re-vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
- •Central laboratory reported platelet count <140,000 per mm3
- •Active liver disease or hepatic dysfunction at Screening visit
结局指标
主要结局
Change in log-transformed Lp(a) concentration from baseline at Month 6
Change in log-transformed Lp(a) concentration from baseline at Month 6
次要结局
- Proportion of participants achieving Lp(a) levels <125 nmol/L at Month 6
- Incidence of treatment emergent adverse events (TEAEs):
- Incidence of treatment emergent serious adverse events (TESAEs)
- Incidence of treatment emergent adverse events of special interest (AESI)
- Incidence of study and treatment discontinuations due to TEAEs;
- Observed value and change/shift from baseline in safety laboratory measures; • ECGs • Vital signs • Laboratory values (e.g. CBC, CMP, Liver Function Tests)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (45)
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