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ARTICLE | Clinical News

Lomitapide: Additional Phase III data

June 6, 2011 7:00 AM UTC

Data from a completer analysis of 23 evaluable patients in a single-arm, open-label, international Phase III trial showed that oral lomitapide titrated up to 60 mg/day reduced mean LDL-C by 50.2% from baseline to week 26, which Aegerion said met the primary endpoint by demonstrating a 50% mean change from baseline. Lomitapide also reduced median triglycerides by 56.1% from baseline to week 26. An intent-to-treat (ITT) last observation carried forward (LOCF) analysis of 29 patients in the trial showed that lomitapide reduced mean LDL-C by 40.1% and median triglycerides by 44.6% from baseline to week 26.

In 23 evaluable patients who completed 56 weeks of treatment with lomitapide, the compound reduced mean LDL-C by 44% and median triglycerides by 33.3% from baseline to week 56. Additionally, lomitapide increased mean hepatic fat levels from 1.2% at baseline to 7.3% at week 56. Aegerion said 3 patients discontinued the trial due to gastrointestinal adverse events and 3 patients withdrew consent to participate. ...