NCT07604974招募中2 期
A Phase 2, Open-label Trial Evaluating the Safety, Tolerability and Efficacy of ION775 in Adults With Hypertriglyceridemia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 17
研究概览
简要总结
The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).
详细描述
This is an open-label, parallel-dose study consisting of a 4-6 week screening period, a 6-month treatment period and a 6-month post-treatment follow-up period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females with HTG (fasting TG more than or equal to (≥) 350 milligrams per deciliter (mg/dL) [3.95 millimoles per liter (mmol/L)] or with sHTG (fasting TG ≥ 500 mg/dL [5.65 mmol/L]).
- •Participants should be on standard of care lipid-lowering medications per local guidelines.
排除标准
- •Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening.
- •Alanine aminotransferase or aspartate aminotransferase > 2.0 × upper limit of normal.
- •Total bilirubin > 1.5 upper limit of normal unless due to Gilbert's syndrome.
- •Estimated GFR < 30 mL/min/1.73 m^
- •Note: Other protocol pre-specified inclusion/exclusion criteria may apply.
研究组 & 干预措施
ION775: Cohot B
Experimental
Participants will be randomized to receive ION775 by SC injection.
干预措施: ION775 (Drug)
ION775: Cohot C
Experimental
Participants will be randomized to receive ION775 by SC injection.
干预措施: ION775 (Drug)
ION775: Cohot A
Experimental
Participants will be randomized to receive ION775 by subcutaneous (SC) injection.
干预措施: ION775 (Drug)
研究者
研究点 (17)
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