Novo Nordisk re-initiates trials for Victoza

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Novo Nordisk has re-initiated its phase 3 development for liraglutide (Victoza) as a treatment for obesity after the drug gained FDA approval for its indication to treat type 2 diabetes last January.

After feedback from the FDA, Denmark-based Novo Nordisk will re-start its liraglutide obesity trials that will enroll more than 5,000 patients during the first half of 2011 to study a fixed-ratio combination of both insulin degludec and liraglutide, and a once-a-week dose of liraglutide.

LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results), a multi-center, randomized, double-blind, placebo-controlled trial will evaluate 9,000 patients over five years to compare liraglutide treatment to standard treatments for type 2 diabetes patients.

Additionally, Novo said that it will develop a strategy to produce semaglutide, a one-weekly glucagon-life peptide-1 (GLP-1) and the once-weekly version of liraglutide in 2011.