NCT07229937招募中2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of HRS-1301 in Participants With Dyslipidemia
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2025年11月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Percentage change in LDL-C relative to baseline
研究概览
简要总结
The purpose of the study is to explore the reasonable dosage of HRS-1301 in participants with dyslipidemia. The efficacy and safety of HRS-1301 will be evaluated after 12-weeks treatment.
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 and female ≥ 18 years old, who is able and willing to provide a written informed consent
- •BMI ≥ 18.0 kg/m2
- •Clinically diagnosed with ASCVD and LDL-C ≥ 1.8 mmol/L OR, if no history of ASCVD, has intermediate to high risk of developing ASCVD and LDL-C ≥ 2.6 mmol/L
- •Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and for 2 weeks after the last dose, and agree to use contraceptive methods as specified in the protocol
排除标准
- •TG > 5.6 mmol/L
- •Diagnosed with homozygous familial hypercholesterolemia (HoFH)
- •Acute ischemic ASCVD events within 12 months before screening, or during the screening and run-in phase
- •Heart failure with New York Heart Association (NYHA) Class III-IV
- •Malignant tumors within 5 years
- •Received or is regularly receiving LDL or plasma apheresis within 12 months before screening
- •History or presence of severe gastrointestinal, hepatic, or renal diseases, or other known diseases that may interfere with drug absorption, distribution, metabolism, or excretion
- •Uncontrolled diabetes mellitus and/or hypertension
- •Has undergone transplantation of any vital organ, such as lung, liver, heart, bone marrow, or kidney
研究组 & 干预措施
HRS-1301 Group A
Experimental
干预措施: HRS-1301 (Drug)
HRS-1301 Group B
Experimental
干预措施: HRS-1301 (Drug)
HRS-1301 Group C
Experimental
干预措施: HRS-1301 (Drug)
HRS-1301 Group D
Experimental
干预措施: HRS-1301 (Drug)
HRS-1301 Group E
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change in LDL-C relative to baseline
时间窗: at 12 weeks of treatment
次要结局
- Proportion of subjects achieving LDL-C goals(at 12 weeks of treatment)
- Percentage change in TC relative to baseline；(at 12 weeks of treatment)
- Percentage change in HDL-C relative to baseline；(at 12 weeks of treatment)
- Percentage change in TG relative to baseline；(at 12 weeks of treatment)
- Percentage change in non-HDL-C relative to baseline；(at 12 weeks of treatment)
- Percentage change in ApoB relative to baseline；(at 12 weeks of treatment)
- Percentage change in ApoA1 relative to baseline；(at 12 weeks of treatment；)
- Percentage change in Lp(a) relative to baseline；(at 12 weeks of treatment；)
- Percentage change in hsCRP relative to baseline；(at 12 weeks of treatment；)
- Number of participants with one or more adverse events(during the study period；Approximately half a year)
研究者
研究点 (1)
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