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Underwhelming results for Victoza

pharmafile | March 20, 2013 | News story | Sales and Marketing Novo Nordisk, Victoza, diabetes 

Novo Nordisk has reported underwhelming results for a well-established diabetes treatment in a late-stage trial designed to test its weight management properties.

Diabetes patients achieved weight loss of just 6% in a Phase IIIa obesity trial when taking a 3mg dose of Novo’s once-daily GLP-1 analogue Victoza (liraglutide).

The brand has a fine track record in reducing blood sugar, proving its superiority to Merck’s rival Januvia (sitagliptin), for example, but it is not licenced as a weight management treatment.

The double-blind trial looked at Victoza’s potential to induce and maintain weight loss in overweight or obese people with type II diabetes.

Victoza is currently approved at 1.2mg and 1.8 mg for diabetes and observers will have been hoping for a better showing from the higher dose when it comes to reducing weight. 

In the trial, 846 overweight or obese people with type II diabetes were randomised to have 3 mg, 1.8 mg or placebo for 56 weeks, after which they were observed for another 12 weeks.

From a mean baseline of 106 kg and a BMI of 37, weight loss was 6% (for patients treated with Victoza 3 mg) and 5% (1.8 mg) compared to 2% with placebo.

During the follow-up period, patients in both Victoza treatment groups experienced a ‘moderate’ weight regain.

The results as they stand probably do not point to immediate commercial success in weight loss treatment. However, Novo said it was happy with the data: the trial met all three co-primary endpoints.

“We are pleased about the outcome of this trial and look forward to getting the results from the two remaining trials in the SCALE programme,” said Mads Krogsgaard Thomsen, Novo’s executive vice president and chief science officer.

“Weight management is often a greater challenge for this patient population and there is a need for new and effective treatment options,” Thomsen added. 

As expected, more than two-thirds of patients taking Victoza achieved the HbA1c treatment target of 7% recommended by the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD).

Adam Hill

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