NCT07100418进行中（未招募）2 期
A Multicenter, Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-7249 in Patients With Hyperlipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- The level of triglyceride (TG)
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HRS-7249 for patients with hyperlipidemia, and to explore the reasonable dosage of HRS-7249 for patients with hyperlipidemia.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent.
- •Age ≥ 18 years old and < 80 years old.
- •Male or female.
排除标准
- •Acute pancreatitis within 3 months or within 4 weeks or planned for plasma exchange treatment.
- •Malignant tumors within 5 years.
- •Severe cardiovascular or cerebrovascular diseases.
- •Severe trauma or surgery within 6 months or severe infection within 3 months.
- •Previous diagnosed diseases affecting lipid levels.
- •Patients with unstable or severe diseases assessed as at risk by the investigator.
- •Uncontrolled hypertension.
- •Weight loss within 2 months or planned surgery causing unstable weight.
- •Uncontrolled diabetes.
- •Combined hyperthyroidism or hypothyroidism.
- •History of drug or alcohol abuse.
- •Significantly abnormal liver or kidney function.
- •Significantly abnormal blood routine.
- •Significantly abnormal thyroid function.
- •Participated in clinical research within 3 months.
- •Pregnant or lactating women, or refusing contraception.
研究组 & 干预措施
HRS-7249 Group
Experimental
干预措施: HRS-7249 Injection (Drug)
Sodium Chloride Injection Group
Placebo Comparator
干预措施: Sodium Chloride Injection (Drug)
结局指标
主要结局
The level of triglyceride (TG)
时间窗: About 28 weeks.
次要结局
- Adverse events (AEs)(About 48 weeks.)
研究者
研究点 (1)
Loading locations...
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