NCT07799129尚未招募2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Dose-Finding Study to Evaluate the Efficacy and Safety of EDP167 in Adult Patients With Mixed Dyslipidemia
Eddingpharm (Zhuhai) Co., Ltd.2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年11月1日最近更新:
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
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24
研究概览
简要总结
EDP167 is a double-stranded small interfering RNA (siRNA) drug targeting angiopoietin-like 3 protein (ANGPTL3), which may bring benefits for patients with dyslipidemia conditions. This Phase 2 clinical study comprises two phases: a randomized, double-blind, placebo parallel-controlled core study and an open-label extension study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥18 years and ≤75 years at the time of signing the informed consent form, male or female, with a BMI of ≥18.5 and <40 kg/m²;
- •Fasting serum TG at screening: TG ≥ 150 mg/dL (1.7 mmol/L) and < 500 mg/dL (5.6 mmol/L), and LDL-C ≥ 70 mg/dL (1.8 mmol/L)
- •Willing to maintain a routine low-fat diet throughout the study
- •Have received stable-dose statin therapy of moderate intensity or higher for at least 4 weeks prior to lipid testing at screening (unless statin-intolerant).
排除标准
- •Participants who have used any antisense oligonucleotide (ASO) or small interfering RNA (siRNA) agents within 12 months prior to randomization;
- •Participants who have received or are receiving ANGPTL3- or ApoC3-targeted therapy, or have participated in any other clinical drug study within 6 months prior to screening or within 5 half-lives (whichever is longer);
- •Participants planning to undergo bariatric surgery or weight-loss intervention during the study;
- •Participants with uncontrolled medical conditions that may affect lipid or lipoprotein levels, such as nephrotic syndrome, severe hepatic disease, Cushing's syndrome, thyroid disorders, etc.;
- •Participants with a history of acute pancreatitis within 12 weeks prior to randomization;
- •Participants with a history of acute coronary syndrome, stroke, or NYHA Class III-IV heart failure within 24 weeks prior to randomization;
- •Participants who have undergone coronary intervention within 24 weeks prior to randomization or plan to receive coronary intervention or pacemaker implantation during the study;
- •Participants with a history of major surgery within 12 weeks prior to screening or scheduled elective surgery requiring hospitalization during the study;
- •Participants with uncontrolled hypertension at screening.
研究组 & 干预措施
Cohort 2 EDP167 200 mg or volume-matched placebo
Active Comparator
干预措施: EDP167 200mg (Drug)
Cohort 3 EDP167 300mg or volume-matched placebo
Active Comparator
干预措施: EDP167 300mg (Drug)
Cohort 1 EDP167 100 mg or volume-matched placebo
Experimental
干预措施: EDP167 100mg (Drug)
结局指标
主要结局
Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24
时间窗: From baseline to week 24 of the core study
次要结局
- Percentage and absolute change of TG, LDL-C, non-HDL-C, TC, VLDL-C, HDL-C, ApoB and ANGPTL3 from baseline to Week 24 (excluding the primary endpoint)(From baseline to week 24 of the core study)
研究者
研究点 (2)
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