Victoza liraglutide: Phase IIIa data

Top-line data from the double-blind, international Phase IIIa SCALE Obesity and Pre-diabetes trial in 3,731 patients without diabetes who are overweight or obese with co-morbidities such as pre-diabetes, hypertension and dyslipidemia showed that once-daily 3 mg subcutaneous liraglutide met the 3 co-primary endpoints of reducing mean body weight from baseline to week 56 (8% vs. 2.6%) and of increasing the proportion of patients who achieved weight loss of >=5% (64% vs. 27%) and >10% (33% vs. 10%) of baseline body weight at week 56 vs. placebo. On secondary endpoints, a significantly greater proportion of patients with pre-diabetes at baseline (61%) who were treated with liraglutide no longer showed signs of pre-diabetes at week 56 vs. placebo (69% vs. 33%). Furthermore, of the 39% of patients without pre-diabetes at baseline, a significantly smaller proportion of patients treated with liraglutide developed pre-diabetes vs. placebo (7% vs. 21%). Novo Nordisk also said liraglutide significantly improved blood pressure, cardiovascular biomarkers, lipids and patient-reported quality of life vs. placebo. P-values were not disclosed for any endpoint.

According to FDA's 2007 draft guidance, obesity drugs must have either a 5% placebo-adjusted weight loss, or at least 35% of patients in the treatment arm must experience 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% body weight loss and this proportion must be at least double the proportion in the placebo group. Liraglutide met both benchmarks in the trial. Liraglutide was generally well tolerated. The most common adverse events reported were gastrointestinal-related and diminished over time. Patients without signs of pre-diabetes received placebo or liraglutide in combination with diet and exercise for 56 weeks, followed by a 12-week follow-up period. Patients with signs of pre-diabetes at the time of randomization are continuing treatment for an additional 2 years. ...