Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).
研究概览
简要总结
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.
详细描述
This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females ≥ 18 to ≤ 80 years of age
- •Diagnosis of homozygous familial hypercholesterolemia
- •LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
- •Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
- •Bodyweight of ≥ 40 kg at screening
排除标准
- •History of liver transplant
- •Uncontrolled hypertension
- •Moderate to severe renal dysfunction
- •Active liver disease or hepatic dysfunction
- •Known sensitivity to any of the products to be administered during dosing
研究组 & 干预措施
Part 2: IBI306
Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks.
干预措施: IBI306 (Biological)
Part 1: IBI306
Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks.
干预措施: IBI306 (Biological)
结局指标
主要结局
Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).
时间窗: Baseline and Week 12
Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: Baseline and Week 12
次要结局
未报告次要终点