Conditions: Hyperlipidemia
Keywords: LDL hepatic fat
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

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.

Arms:
arm 1: Placebo arm 2: 2.5 mg AEGR-733 arm 3: 5 mg AEGR-733 arm 4: 7.5 mg AEGR-733 arm 5: 10 mg AEGR-733 arm 6: 5 mg AEGR-733 + 20 mg atorvastatin arm 7: 5 mg AEGR-733 + 145 mg fenofibrate arm 8: 5 mg AEGR-733 + 10 mg ezetimibe

Interventions: intervention 1: AEGR-733 intervention 2: placebo intervention 3: AEGR-733 intervention 4: AEGR-733 intervention 5: AEGR-733 intervention 6: AEGR-733 and atorvastatin intervention 7: AEGR-733 and fenofibrate intervention 8: AEGR-733 and ezetimibe
Intervention descriptions: intervention 1: 3 capsules each evening for each 4-week period intervention 2: 3 capsules each evening for each 4-week period intervention 3: 3 capsules each evening for each 4-week period intervention 4: 3 capsules each evening for each 4-week period intervention 5: 3 capsules each evening for each 4-week period intervention 6: 3 capsules each evening for each 4-week period intervention 7: 3 capsules each evening for each 4-week period intervention 8: 3 capsules each evening for each 4-week period

Protocol document: