NCT00559962

Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Aegerion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	AEGR-733	3 capsules each evening for each 4-week period
DRUG	placebo	3 capsules each evening for each 4-week period
DRUG	AEGR-733	3 capsules each evening for each 4-week period
DRUG	AEGR-733	3 capsules each evening for each 4-week period
DRUG	AEGR-733	3 capsules each evening for each 4-week period
DRUG	AEGR-733 and atorvastatin	3 capsules each evening for each 4-week period
DRUG	AEGR-733 and fenofibrate	3 capsules each evening for each 4-week period
DRUG	AEGR-733 and ezetimibe	3 capsules each evening for each 4-week period

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2007-11-19
• Last updated: 2018-02-23
• Results posted: 2013-02-22

Locations

15 sites across 1 country: United States