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news.Novo Nordisk has decided to restart a global Liraglutide Phase 3 development programme for the treatment of obesity.
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Novo Nordisk has been in discussion with the FDA regarding further progression of the development programme investigating the potential of Liraglutide within obesity.
Based on the feedback from the FDA, Novo Nordisk now plans to re-initiate the global phase 3 programme in the first half of 2011 in clinical trials comprising approximately 5,000 patients.
Novo Nordisk said that the re-initiation of Liraglutide obesity trials shows its dedication to the development of the Liraglutide portfolio, that is the cardiovascular outcomes trial for Victoza (Leader), the obesity programme, the fixed-ratio combination of insulin degludec and Liraglutide, and finally a once-weekly version of Liraglutide.
Novo Nordisk now expects to outline the clinical development strategy for semaglutide, a once-weekly GLP-1 analogue, and the once-weekly version of Liraglutide in the second half of 2011.