NCT06750341尚未招募2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of QLC7401 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia With Poorly Controlled Low-density Lipoprotein Cholesterol (LDL-C) Elevated on Optimized Lipid-lowering Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 156
- 主要终点
- Percentage changes in LDL-C from baseline to Day 180 and Day 270
研究概览
简要总结
To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.
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)
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
- •Male or female participants aged ≥18 years of age.
- •Serum LDL-C ≥1.8mmol/L for ASCVD participants or ≥2.6mmol/L for other participants at screening.
- •Fasting TG <400mg/dL (<4.5mmol/L) at screening.
- •Stable lipid-lowering therapy for ≥4 weeks at randomization.
- •Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
排除标准
- •Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade II-IV at screening or randomization or latest detected LVEF<30%; (2) CVD events within 3 months; (3) uncontrolled severe hypertension; (4) previous diagnosis of familial hypercholesterolemia; (5) have known allergic reaction to experimental drug, or have severe allergic reaction to other drugs; (6) inadequate organ functions or malignancy history; (7) prior exposure to other RNA inhibitors within 2 years.
- •Any of the laboratory indicators met the following criteria at screening or at randomization: (1) ALT or AST exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 times ULN; (2) creatine kinase (CK) exceeding 3 times ULN; (3) TSH is less than the lower limit or normal (LLN) or exceeds 1.5 times ULN.
- •General conditions: (1) male or female participants who do not agree to use high-efficiency contraceptives during the trial and for 6 months after the last dosing; (2) women who are pregnant or lactating.
- •The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo 100/300/500 mg subcutaneous injection
干预措施: Placebo (Drug)
QLC7401 100mg
Experimental
QLC7401 100 mg subcutaneous injection
干预措施: QLC7401 (Drug)
QLC7401 300mg
Experimental
QLC7401 300 mg subcutaneous injection
干预措施: QLC7401 (Drug)
QLC7401 500mg
Experimental
QLC7401 500 mg subcutaneous injection
干预措施: QLC7401 (Drug)
结局指标
主要结局
Percentage changes in LDL-C from baseline to Day 180 and Day 270
时间窗: 80 days and 270 days
次要结局
- Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360(360 days)
- Percentage changes in LDL-C from baseline at each subsequent visit to Day 360(360 days)
- Value changes in LDL-C from baseline at each subsequent visit to Day 360(360 days)
- Value changes in PCSK9 from baseline at each subsequent visit to Day 360(360 days)
- Percentage changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360(360 days)
- Value changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360(360 days)
- Proportion of participants with LDL-C greater than 80% of baseline value at Day 180, Day 210, Day 270, and Day 360(360 days)
- Duration of treatment for participants to return to 80% of baseline value or greater LDL-C or PCSK9 protein(360 days)
- Proportion of participants who attained global lipid modification targets for level of ASCVD risk(360 days)
- Number of participants with adverse events and injection site reactions, with abnormal vital signs, abnormal physical examination, abnormal 12-ECG, abnormal laboratory assessments(360 days)
- ADA incidence(360 days)
研究者
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