Significantly greater weight loss versus placebo seen in Ph IIIa study of liraglutide 3mg

16 May 2014

Significant weight loss was demonstrated for Danish insulin giant Novo Nordisk’s (NOV: N) diabetes drug liraglutide in the results from the SCALET Obesity and Pre-diabetes Phase IIIa trial being presented for the first time today at the 23rd Annual Congress of the American Association of Clinical Endocrinologists (AACE).

Data showed that after 56 weeks of treatment, liraglutide 3mg, in combination with diet and exercise, provided significantly greater weight loss of 8% from baseline compared to 2.6% with placebo (p<0.0001). This is the largest trial in the SCALET program investigating liraglutide 3mg, an investigational once-daily glucagon-like peptide-1 (GLP-1) analogue for weight management.

Liraglutide is the active ingredient in Novo Nordisk’s blockbuster diabetes drug Victoza, which generated first-quarter sales of 2.92 billion Danish kroner ($538 million) for the company. It is approved and marketed at lower doses of 1.2mg and 1.8mg once-daily. Liraglutide 3mg is an investigational product and is not approved by the US Food and Drug Administration or the European Medicines Agency.

All treatment groups included a reduced-calorie diet and increased physical activity. The proportion of adults achieving weight loss of 5% or more of their baseline body weight was 64% for liraglutide 3mg treatment compared to 27% for placebo (p<0.0001). In addition, 33% of adults treated with liraglutide 3mg achieved weight loss greater than 10% of their baseline body weight compared to 10% for placebo (p<0.0001).

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