A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Low Doses of the MTP-Inhibitor AEGR-733 on Hepatic Fat Accumulation as Measured by Magnetic Resonance Spectroscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 14
- 主要终点
- Absolute Change From Baseline in Percent Hepatic Fat
研究概览
简要总结
To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy
详细描述
The goal within the current development program and this study is to investigate whether lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses of MTP-I on hepatic fat accumulation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL-C between 100 and 190 mg/dL
- •Hepatic fat under 6.2% per MRS
排除标准
- •Pregnant or lactating females
- •Uncontrolled hypertension >180/95 mmHg
- •Chronic renal insufficiency - serum creatinine >2.5 mg/dL at screen
- •Liver disease; i.e., hepatitis, cirrhosis
- •Major surgery within 3 months of screen
- •Cardiac insufficiency
- •Hx of malignancy other than basal or squamous cell within past 5 yrs
- •Participation in any investigational drug study within 6 wks of screen
- •Prior exposure to AEGR-733 in past 12 months
- •Serious or unstable medical or psychological conditions
- •More than one alcoholic drink per day
- •Regular consumption of grapefruit juice or meds known to be metabolized by CYP 3A4
- •Currently taking corticosteroids
- •Other lipid-lowering meds (washout permitted)
- •Fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout permitted)
- •Acute CVD or event within previous 6 months
- •Diabetes Mellitus
- •Hepatitis B or C
- •Medicated COPD
- •Idiopathic pulmonary fibrosis
- •G.I. disorders that cause chronic diarrhea
- •Fasting triglycerides =/> 400 mg/dL
- •Body Mass Index > 35kg/m2
研究组 & 干预措施
2
2.5 mg AEGR-733
干预措施: AEGR-733 (Drug)
1
Placebo
干预措施: placebo (Drug)
3
5 mg AEGR-733
干预措施: AEGR-733 (Drug)
4
7.5 mg AEGR-733
干预措施: AEGR-733 (Drug)
5
10 mg AEGR-733
干预措施: AEGR-733 (Drug)
6
5 mg AEGR-733 + 20 mg atorvastatin
干预措施: AEGR-733 and atorvastatin (Drug)
7
5 mg AEGR-733 + 145 mg fenofibrate
干预措施: AEGR-733 and fenofibrate (Drug)
8
5 mg AEGR-733 + 10 mg ezetimibe
干预措施: AEGR-733 and ezetimibe (Drug)
结局指标
主要结局
Absolute Change From Baseline in Percent Hepatic Fat
时间窗: Baseline and 12 weeks on study drug
Absolute change from Baseline in percent hepatic fat
次要结局
- Absolute Change From Baseline in Percent Hepatic Fat(Baseline and 12 weeks on study drug)