Novo Nordisk (NVO) recently announced top-line data on Victoza (liraglutide) from a double-blind phase IIIa study which was conducted to evaluate the potential of Victoza to induce and maintain weight loss in people without diabetes who are obese or overweight with comorbidities such as prediabetes, hypertension and dyslipidaemia.
The study was conducted on 3,731 obese patients. The patients were randomized 2:1 on Victoza 3 mg or placebo. After a 56-week treatment period, the patients were observed for 12 weeks.
The percentage of patients achieving minimum weight loss of 5% was 64% for Victoza and 27% for placebo. A minimum of 10% weight loss was achieved by 33% of the subjects in the Victoza arm and 10% under placebo.
The study revealed statistically significant data and the trial met all three co-primary endpoints.
This is the third phase IIIa trial to be completed under Novo Nordisk’s SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence in Non-diabetic and Diabetic people) program which consists of four trials.Results from the second of four phase IIIa obesity studies were announced in Mar 2013.
Novo Nordisk expects to complete the remaining trials in the third quarter of this year and file for the obesity indication in the US and EU by year end.
The obesity market has significant commercial potential and currently approved drugs include Qsymia and Belviq. Meanwhile, Orexigen Therapeutics, Inc. (OREX) is developing Contrave for the treatment of obesity.
Victoza is currently approved at lower doses (1.2, 1.8 and 0.9 mg) for type II diabetes only. The 3 mg dosage is not an approved treatment yet. In the first quarter 2013, Victoza generated revenues of DKK 2.7 billion.
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