A Phase 2 Study to Evaluate the Effect of Obicetrapib Alone and in Combination With Evolocumab (Repatha®) on Lipoprotein (a) in Patients With Mild Dyslipidemia: The VINCENT Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]).
研究概览
简要总结
The goal of this open label 16 week trial is to evaluate Lp(a) levels for patients with elevated Lp(a) being treated with obicetrapib and obiceptrapib/evolocumab
Patients will:
Have baseline Lp(a) tested at randomization Take 10mg/dL obiceptrapib daily for 8 weeks and have Lp(a) tested at Week 8 Take 10 mg/dL obicetrapib daily/evolocumab 140 every other week for 8 weeks and have Lp(a) retested at Week 16
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Lp(a): >=50 mg/dL (>=125 nmol/L) for cohort 1 (FILLED) and Lp(a) >= 20 mg/dL (>= 50 nmol/L) to <50 mg/dL (< 125 nmol/L) for cohort 2
- •LDL-C >70 mg/dL
- •TG < 400mg/dL (<4.52 mmol/L)
排除标准
- •HbA1c>=10 or FPG >=270 mg/dL
- •CV events within 3 months of screen
研究组 & 干预措施
obicetrapib/evolocumab combination
obicetrapib 10 mg/dL daily for 8 weeks followed by obicetrapib 10 mg/dL daily + evolocumab 140 mg/dL every other week for 8 weeks
干预措施: obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks (Drug)
结局指标
主要结局
To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]).
时间窗: 16 weeks from baseline; 8 weeks on combination therapy
Lp(a) change on combination therapy
次要结局
- To evaluate the effect of obicetrapib alone on Lp(a).(8 weeks)