NCT07269210招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 83
- 主要终点
- Change from Baseline in Triglycerides
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of solbinsiran in lowering triglycerides and other lipid measures compared to placebo in participants with severe hypertriglyceridemia. Participants will receive two subcutaneous injections.
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
- Double (Participant, Investigator)
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
- •History of fasting triglyceride levels of ≥500 milligrams per deciliter (mg/dL), based on medical history
- •Fasting triglyceride level ≥500 mg/dL at two separate visits during screening (at least 7 days apart)
- •Have a body mass index (BMI) within the range of 18.5 to 45.0 kilograms per square meter (kg/m2) (inclusive)
排除标准
- •Have had a major atherosclerotic cardiovascular event within the past 3 months prior to screening
- •Have a known genetically confirmed diagnosis of Familial Chylomicronemia Syndrome
- •Have a history of or planned treatment involving any gene editing or gene therapy modalities, including but not limited to CRISPR-based, viral vector-mediated, or other genetic modification techniques
- •Have a history of chronic alcohol abuse within 3 years prior to screening
研究组 & 干预措施
Solbinsiran
Experimental
Participants will receive solbinsiran subcutaneously (SC)
干预措施: Solbinsiran (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Triglycerides
时间窗: Baseline, Weeks 16-24 (Time-Average)
次要结局
- Change from Baseline in Angiopoietin-like-3 (ANGPTL3)(Baseline, Week 24)
- Change from Baseline in Very-Low-Density Lipoprotein-Cholesterol (VLDL-C)(Baseline, Week 24)
- Change from Baseline in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)(Baseline, Week 24)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Curve from Hour 0 to Infinity (AUC 0-∞)(Week 0: 0.5 hour (hr) and 4 to 9 hr postdose, Week 12: 24 to 36 hr postdose)
研究者
研究点 (83)
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