NCT07441317尚未招募3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety 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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 780
- 主要终点
- Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)
研究概览
简要总结
To evaluate the efficacy, safety and immunogenicity of QCL7401 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 low density lipoprotein cholesterol (LDL-C) ≥1.8mmol/L for participants with atherosclerotic cardiovascular disease (ASCVD) or ≥2.6mmol/L for other participants at screening.
- •Fasting Total Cholesterol (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 III-IV at screening or randomization ; (2) Cardiovascular diseases 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 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 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
QLC7401 Injection
Experimental
Participants receive QLC7401 at a pre-defined dosage via subcutaneous injection according to the study schedule.
干预措施: QLC7401 (Drug)
Placebo
Placebo Comparator
Participants receive placebo via subcutaneous injection according to the study schedule.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: From baseline to Day 330
次要结局
- Incidence of Treatment-Emergent Adverse Events (TEAEs(Throughout the study duration])
- Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C(Day 90 to Day 360)
- Change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline(From baseline to Day 360)
研究者
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