Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor
Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the safety and tolerability of 4 doses of
lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an
additional 3 dose levels over a 16-week period.
The secondary objectives of this study included the evaluation of the pharmacodynamics of
lomitapide based on:
- Percent change in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC),
triglycerides, and very low density lipoprotein cholesterol (VLDL-C) concentrations at
the end of each 4-week dosing period compared to the Baseline value of each parameter at
the end of the previous dose phase(s).
- Changes in other plasma lipoproteins: apolipoproteins (apo B, apo AI, apo AII, apo CIII,
apo E) and lipoprotein a [Lp(a)].
Phase:
Phase 2
Details
Lead Sponsor:
Aegerion Pharmaceuticals, Inc.
Collaborators:
Doris Duke Charitable Foundation University of Pennsylvania