Danish pharmaceutical company Novo Nordisk has decided to conduct a separate clinical trial of its promising type 2 diabetes treatment, Liraglutide, for use as a diet drug by obese people who are not diabetics.

Liraglutide, a long-acting derivative of the natural hormone glucagon-like peptide-1 (GLP-1), in phase II trials improved the ability of pancreatic beta cells to secrete insulin in people with type 2 diabetes

Chief Science Officer Mads Krogsgaard Thomsen said Novo Nordisk has recruited 60 percent of patients it needs for a phase III trial of Liraglutide as a diabetes medication, and expects to file for regulatory approval of Liraglutide as an injectible diabetes drug in the U.S. and Europe in 2008.

But even as it is conducting the phase III trial, Novo Nordisk said it plans to start a phase II trial of Liraglutide as a treatment for obesity in the first quarter of 2007.

The reason: in a three-month study of Liraglutide as a treatment for diabetes, the two higher doses of the drug tested resulted in a mean weight loss of 5 to 6 pounds.

"You would expect a greater weight loss in non-diabetic patients than in diabetic patients," said Peter Kristensen, project vice president for Liraglutide.

The most common side effects reported by diabetic patients taking Laraglutide were headaches and nausea.

For the 20-week obesity trial, Kristensen said participating centers will recruit 550 non-diabetic participants with a BMI of between 30 and 40 whose weight has been relatively stable during the previous three months.

A substantial proportion of the participants will have early signs that they are developing type 2 diabetes, such as impaired fasting glucose or impaired glucose tolerance, he said.

In addition to one control group that will receive a placebo, participants in a second group will receive diet drug Xenical (orlistat) for comparison. All participants will follow a slightly reduced calorie low-fat diet and receive exercise instruction.

Kristensen said efficiency will be the most important factor as to whether Liraglutide is a successful treatment for obesity, and said he thought the fact that Liraglutide would need to be injected once a day would not be a problem.

"Patients are willing to go much further than that to lose weight," he said.