A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Diazoxide Choline in Non-Diabetic Hypertriglyceridemic Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 12
- 主要终点
- To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
研究概览
简要总结
Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease.
Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia.
Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •triglycerides ≥ 250 mg/dL and < 600 mg/dL
- •BMI between 18.5 and 45
- •Signed informed consent form
排除标准
- •Fasting glucose ≥ 126 mg/dL
- •Glycosylated hemoglobin (HbA1c) > 6.5%
- •LDL cholesterol > 190 mg/dL
- •Known history of type I and II DM
- •Known history of type I and III hyperlipidemia
- •Weight change > 3 kg between screening and baseline visits
- •Pregnancy or intention to become pregnant
- •Presence of significant underlying conditions that may interfere with the assessments of the study drug
研究组 & 干预措施
4
干预措施: Placebo (Drug)
1
Diazoxide equivalent dose
干预措施: Diazoxide choline (Drug)
2
Diazoxide equivalent dose
干预措施: Diazoxide choline (Drug)
3
Diazoxide equivalent dose
干预措施: Diazoxide choline (Drug)
结局指标
主要结局
To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
时间窗: 8 weeks
次要结局
- To assess the effect on other lipid parameters (LDL, HDL, VLDL, and non-HDL cholesterol), insulin, glucose and weight of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects(8 weeks)
- To assess the safety and tolerability of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects(8 weeks)