Aegerion Initiates Phase 3 Trial Of Lomitapide

(RTTNews) - Aegerion Pharmaceuticals, Inc. (AEGR) Wednesday said patient enrollment has been initiated in Japan in a clinical trial of lomitapide as an adjunct treatment to reduce low-density lipoprotein cholesterol in Japanese patients with homozygous familial hypercholesterolemia.

Aegerion previously received orphan drug designation from Japan's Ministry of Health, Labour and Welfare for lomitapide.

The phase three, open-label trial in Japan is estimated to enroll five to 10 adult patients who are receiving concomitant lipid-lowering therapies, including, in some cases, apheresis. After a six week run-in period, patients will receive lomitapide for 26 weeks.

The primary endpoint is change in LDL-C levels from baseline to week 26. Secondary endpoints include change in lipid parameters, long-term safety, and changes in hepatic fat from baseline to week 56.

The company currently hopes to submit the filing for marketing approval in Japan as early as mid-2015.