NCT05255458已完成3 期
A Phase 3 Clinical Study Evaluating the Long-term Efficacy and Safety of AK102 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
Akeso1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年11月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Precentage change from baseline of serum LDL-C level
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the long-term efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.
详细描述
This is a Phase 3 clinical study to evaluate the long-term efficacy and safety of AK102, a monoclonal antibody, against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed 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
- •Subject understand and voluntarily sign the written Inform Consent Form (ICF), which must be signed before performing the study procedures.
- •Male or female patients aged between 18 and 80 years (including upper and lower limits).
- •The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
- •Triglyceride ≤ 4.5 mmol/L (400 mg/dl).
排除标准
- •Homozygous Familial Hypercholesterolemia (HoFH).
- •Received PCSK9 inhibitors within 6 months before randomization.
- •Known sensitivity to PCSK9 inhibitors and any substances to be administered.
- •Severe liver and renal dysfunction.
- •Previously received organ transplantation.
- •Uncontrolled hypothyroidism or hyperthyroidism.
- •Uncontrolled hypertension.
- •Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.
- •History of malignancy of any organ system within the past 5 years.
- •Pregnant or lactating women.
研究组 & 干预措施
AK102 regimen 1
Experimental
干预措施: AK102 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Precentage change from baseline of serum LDL-C level
时间窗: At week 52
The incidence and severity of adverse events (AE)
时间窗: Week 0-52
次要结局
- Value and percentage change from baseline of serum non HDL-C levels(Week 0-52)
- Value and percentage change from baseline of serum TC levels(Week 0-52)
- Value and percentage change from baseline of serum TG levels(Week 0-52)
- Value and percentage change from baseline of serum ApoB levels(Week 0-52)
- Value and percentage change from baseline of serum HDL-C levels(Week 0-52)
- Value and percentage change from baseline of serum ApoA-I levels(Week 0-52)
- Value and percentage change from baseline of serum Lp(a) levels(Week 0-52)
- Evaluate the population pharmacokinetic (PK) characteristics of AK102 , such as AK102 concentration(Week 0-52)
- Number and percentage of subjects with positive anti-AK102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity(Week 0-52)
研究者
研究点 (1)
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