Novo Nordisk's diabetes drug Victoza produced 8% weight loss in Ph III obesity trial

Danish insulin giant Novo Nordisk (NOV: N) has released headline results from a 56-week double-blind Phase IIIa clinical trial investigating the potential of liraglutide, the active ingredient of its type 2 diabetes agent Victoza, to induce and maintain weight loss in people without diabetes who are obese or overweight with co-morbidities such as pre-diabetes, hypertension and dyslipidemia.

This is the third Phase IIIa trial to be completed as part of SCALE, the clinical development program for liraglutide 3mg as an obesity treatment. Novo Nordisk expects to complete the remaining Phase IIIa trial in the SCALE program in the third quarter of 2013 and to file liraglutide for regulatory review as a treatment for obesity in the USA and European Union around the turn of the year.

Although Novo Nordisk has declined to project eventual sales of liraglutide in the obesity setting, according to a Reuters report, but said the new product would cost around $20 a day, or more than $7,000 a year, so it would take fewer than 150,000 patients to make it a $1 billion-a-year product.

While on pure efficacy grounds liraglutide looks easily approvable, it is safety that will determine its real potential, say analysts at EP Vantage, a unit of Evaluate Group. "True, the study saw a relatively low rate of patient withdrawals, but the GLP-1 class’s side effects are hard for patients to spot, and the US Food and Drug Administration might be further troubled by Novo’s proposed use of almost twice the dose approved in diabetes," they noted.

Trial details