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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
260
Scripps Clinic
San Diego, California, United States
Radiant Research
Santa Rosa, California, United States
MedStar Research Institute
Washington D.C., District of Columbia, United States
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
Time frame: Baseline and 12 weeks on study drug
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
Time frame: Baseline and 12 weeks on study drug
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3 capsules each evening for each 4-week period
3 capsules each evening for each 4-week period
3 capsules each evening for each 4-week period
3 capsules each evening for each 4-week period
3 capsules each evening for each 4-week period
Radiant Research
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
LMARC
Louisville, Kentucky, United States
Maine Research Associates
Auburn, Maine, United States
Health Trends Research
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Washington Univ. School of Medicine
St Louis, Missouri, United States
...and 5 more locations