Novo Nordisk Announces Positive Results Of 2 Phase III Trials Of Liraglutide In Obesity and Diabetes

Novo Nordisk announced in a press release that liraglutide slowed the progression to prediabetes in obese adults and had a positive effect on cardiovascular risk markers.

The company also recently announced that liraglutide helped adults lose a significant amount of weight and improved cardiovascular risk factors in adults with obesity and type 2 diabetes. Novo Nordisk announced the results at the International Congress of Endocrinology (ICE) and the Endocrine Society’s meeting (ENDO) in Chicago.

Lead investigator Dr. Xavier Pi-Sunyer, Co-Director of The New York Obesity Nutrition Research Center, said, "It’s encouraging to see the weight loss demonstrated by liraglutide 3 mg, combined with the improvements in blood glucose levels and other cardiovascular risk factors such as blood pressure and lipids."

SCALE Obesity and Prediabetes Trial

The SCALE Obesity and Prediabetes trial evaluated liraglutide in obese but non-diabetic people and in overweight but non-diabetic people. The study included 3,731 people who were treated with liraglutide 3 mg or a placebo. Patients were also counseled in diet and exercise. Investigators sought to delay the onset of type 2 diabetes and see meaningful weight loss at 56 weeks. Results showed that the liraglutide group had a higher rate of prediabetes reversal compared with the placebo group. Patients demonstrated positive indications in cardiovascular risk factors and inflammatory markers. The liraglutide group lost an average 8 percent of their body weight compared to 2.6 percent in the placebo group. 

SCALE Diabetes Trial

The SCALE Diabetes trial was a multinational, placebo-controlled, Phase IIIa clinical trial of liraglutide 3 mg. The study enrolled 846 overweight or obese adults who also have type 2 diabetes. The primary endpoint was the demonstration of clinically meaningful weight loss. Results showed that patients did demonstrate meaningful weight loss at 56 weeks. Patients also improved in cardiovascular (CV) disease risk factors compared to a placebo. 

Liraglutide

Liraglutide is an investigational agent that has not been approved by the Food and Drug Administration (FDA) for obesity disorders. The glucagon-like peptide-1 (GLP-1) analogue is similar to human GLP-1, a hormone that regulates appetite and food intake. Liraglutide helps the patient experience a feeling of satiety or fullness. The agent regulates blood glucose and appetite, which is necessary for patients with diabetes and obesity.