A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Study to Assess Efficacy and Safety of AKR-963 Therapy in Subjects With Severe Hypertriglyceridemia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]
研究概览
简要总结
The primary objective is to determine the efficacy of AKR963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 1500 mg/dL.
详细描述
Increases in triglyceride concentrations have been correlated with increased risk for pancreatitis as well as for coronary heart disease (Ginsberg 2001, 2002). The incidence rates for major coronary events in the Munster Heart Study increased from 4.4% among Subjects with baseline TG concentrations under 200 mg/dL to 9.3% among Subjects with TG concentrations in the 200-399 mg/dL range, and up to 13.2% in Subjects with TG levels ranging from 400-799 mg/dL (Assmann 1996).
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages 18-79
- •Fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL
- •Provide written informed consent and authorization for protected health information disclosure
排除标准
- •Women who are pregnant or lactating, or planning to become pregnant
- •Use of non-statin lipid-altering drugs which cannot be stopped or other supplements with potential lipid-altering effects
- •History of pancreatitis
- •History of bariatric surgery or currently on weight loss drugs or in weight loss programs
- •Treatment with any agent that may affect lipid levels or hepatic function
- •Consumption of more than 3 alcoholic beverages per day
- •History of cancer within last 2 years
- •Participation in another clinical trial involving an investigational agent in the last 30 days
- •Other parameters will be assessed at the study center to ensure eligibility for this study
研究组 & 干预措施
Active Comparator
Active comparator
干预措施: AKR-963 (Drug)
Placebo
Placebo control
干预措施: AKR-963 (Drug)
AKR-963
Investigational drug
干预措施: AKR-963 (Drug)
结局指标
主要结局
Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]
时间窗: 12 weeks
The percent change in TG levels from baseline (average of Weeks -2, -1, and 0) to the end of Period A, first 12-week double-blind treatment, (average of Weeks 11 and 12).
次要结局
未报告次要终点