Novo Nordisk (NVO) to Begin Phase 3 Development of Semaglutide
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Novo Nordisk (NYSE: NVO) today announced the decision to initiate the global phase 3 development programme for semaglutide, a once-weekly human GLP-1 (Glucagon-Like Peptide-1) analogue.
Semaglutide successfully completed phase 2 development in 2010. At that time, it
was decided to compare semaglutide with a once-weekly formulation of liraglutide
being studied in phase 1 trials before selecting a candidate for phase 3 development. Liraglutide is the active component in Victoza®, Novo Nordisk’s once-daily human GLP- 1 product.
These, now completed, phase 1 trials reconfirmed the safety profile of liraglutide, but semaglutide has been assessed to have a more attractive profile for once-weekly administration. Consequently, Novo Nordisk has decided to focus on further development of semaglutide, while no further clinical activities with the once-weekly version of liraglutide are expected.
Novo Nordisk now plans to initiate the first phase 3 study in the SUSTAIN™
programme in the first half of 2013. The global clinical development programme is
expected to include more than 8,000 patients.
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Semaglutide successfully completed phase 2 development in 2010. At that time, it
was decided to compare semaglutide with a once-weekly formulation of liraglutide
being studied in phase 1 trials before selecting a candidate for phase 3 development. Liraglutide is the active component in Victoza®, Novo Nordisk’s once-daily human GLP- 1 product.
These, now completed, phase 1 trials reconfirmed the safety profile of liraglutide, but semaglutide has been assessed to have a more attractive profile for once-weekly administration. Consequently, Novo Nordisk has decided to focus on further development of semaglutide, while no further clinical activities with the once-weekly version of liraglutide are expected.
Novo Nordisk now plans to initiate the first phase 3 study in the SUSTAIN™
programme in the first half of 2013. The global clinical development programme is
expected to include more than 8,000 patients.
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