Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
- Conditions
- Hyperlipidemia
- Interventions
- Registration Number
- NCT00559962
- Lead Sponsor
- Aegerion Pharmaceuticals, Inc.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- LDL-C between 100 and 190 mg/dL
- Hepatic fat under 6.2% per MRS
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 AEGR-733 10 mg AEGR-733 6 AEGR-733 and atorvastatin 5 mg AEGR-733 + 20 mg atorvastatin 7 AEGR-733 and fenofibrate 5 mg AEGR-733 + 145 mg fenofibrate 1 placebo Placebo 2 AEGR-733 2.5 mg AEGR-733 3 AEGR-733 5 mg AEGR-733 8 AEGR-733 and ezetimibe 5 mg AEGR-733 + 10 mg ezetimibe 4 AEGR-733 7.5 mg AEGR-733
- Primary Outcome Measures
Name Time Method Absolute Change From Baseline in Percent Hepatic Fat Baseline and 12 weeks on study drug Absolute change from Baseline in percent hepatic fat
- Secondary Outcome Measures
Name Time Method Absolute Change From Baseline in Percent Hepatic Fat Baseline and 12 weeks on study drug Absolute change from Baseline in percent hepatic fat
Trial Locations
- Locations (14)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Scripps Clinic
🇺🇸San Diego, California, United States
MedStar Research Institute
🇺🇸Washington, District of Columbia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
LMARC
🇺🇸Louisville, Kentucky, United States
Washington Univ. School of Medicine
🇺🇸Saint Louis, Missouri, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Sterling Research Group
🇺🇸Cincinnati, Ohio, United States
Health Trends Research
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
dgd Research
🇺🇸San Antonio, Texas, United States
Radiant Research
🇺🇸Chicago, Illinois, United States