NCT07444086尚未招募3 期
Evaluation of Efficacy and Safety of QLC7401 Monotherapy in Participants With Non-familial Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 510
- 主要终点
- Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline
研究概览
简要总结
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.
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
- •Aged ≥18 years.
- •Fasting low density lipoprotein cholesterol (LDL-C) ≥2.6 mmol/L and <4.9 mmol/L at screening.
- •Atherosclerotic cardiovascular disease (ASCVD) risk stratification as low or intermediate risk per Chinese guidelines.
- •Not currently on lipid-lowering therapy.
- •estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m².
- •Willing to provide informed consent.
排除标准
- •History of AAtherosclerotic cardiovascular disease (ASCVD)(e.g., myocardial infarction, stroke).
- •Familial hypercholesterolemia.
- •Uncontrolled hypertension (Systolic Blood Pressure ≥160 mmHg or (Diastolic Blood Pressure ≥100 mmHg).
- •Poorly controlled type 2 diabetes (Glycated Haemoglobin A1c >8.0%).
- •Use of prohibited lipid-lowering drugs within specified washout periods.
- •Significant liver or kidney disease.
- •Pregnancy or lactation.
- •Other conditions deemed unsuitable by investigator.
研究组 & 干预措施
QLC7401
Experimental
干预措施: QLC7401 (Drug)
Placebo Group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline
时间窗: From baseline to Day 330
次要结局
- Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)(Day 90 to Day 360)
- Change in concentration of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline(From baseline to Day 360)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(From baseline to Day 360)
研究者
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