Novo's liraglutide meets obesity endpoints

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said once-daily 3 mg subcutaneous liraglutide met the three co-primary endpoints in the Phase IIIa SCALE Obesity and Pre-diabetes trial to treat obesity. Liraglutide reduced mean body weight from baseline to week 56 (8% vs. 2.6%). It also increased the proportion of patients who achieved weight loss of 5% or greater (64% vs. 27%) and greater than 10% (33% vs. 10%) of baseline body weight at week 56 vs. placebo. P-values were not disclosed.

According to FDA's 2007 draft guidance, obesity drugs must have either a 5% placebo-adjusted weight loss, or at least 35% of patients in the treatment arm must experience 5% or greater body weight loss and this proportion must be at least double the proportion in the placebo group. Liraglutide met both benchmarks in the double-blind trial, which enrolled 3,731 patients without diabetes who are overweight or obese with co-morbidities such as pre-diabetes, hypertension and dyslipidemia. ...