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 SUSTAINTM program in the first half of 2013. The global clinical development program is expected to include more than 8,000 patients.