Millendo announced today they have successfully enrolled 150 patients into their Phase 2b/3 clinical study of livoletide, completing enrollment for patients ages 8 to 85. The trial will continue to enroll patients ages 4 to 7 years old, and a minimum of 44 lbs. With the study now fully enrolled, topline results are expected in the first half of 2020 which may support a New Drug Application (NDA) filing for livoletide.
The second part of ZEPHYR is a Phase 3 study that will recruit additional patients at the same clinical sites and consists of a six-month double-blind, placebo-controlled core period in which patients will receive livoletide or placebo followed by a six-month extension period in which all patients receive livoletide. The primary endpoint for both the Phase 2b and Phase 3 portions of ZEPHYR is the change in food-related behaviors using the validated Hyperphagia Questionnaire for Clinical Trials (HQ-CT).