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Obesity drugs

SCALE: liraglutide demonstrates significantly greater weight loss

Proportion of adults achieving weight loss of 5 percent or more of their baseline body weight was 64 percent for liraglutide 3mg treatment compared to 27 percent for placebo

After 56 weeks of treatment, liraglutide 3mg, in combination with diet and exercise, provided significantly greater weight loss compared to placebo, according to the results from the SCALE Obesity and Pre-diabetes phase 3a trial.

The outcomes, presented at the 23rd Annual Congress of the American Association of Clinical Endocrinologists (AACE), showed that liraglutide patients reported more weight loss from baseline, 8 percent (8.4 kg) vs. 2.6 percent (2.8 kg) with placebo (p<0.0001).

Liraglutide 3mg

Liraglutide 3mg is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97 percent similarity to naturally occurring human GLP-1. Like human GLP-1, liraglutide 3mg regulates appetite and food intake by decreasing hunger and increasing feelings of fullness and satiety after eating.

All treatment arms included a reduced-calorie diet and increased physical activity. The proportion of adults achieving weight loss of 5 percent or more of their baseline body weight was 64 percent for liraglutide 3mg treatment compared to 27 percent for placebo (p<0.0001).

In addition, 33 percent of adults treated with liraglutide 3mg achieved weight loss greater than 10 percent of their baseline body weight compared to 10 percent for placebo (p<0.0001).

"It is known that a sustained weight loss of 5 to 10 percent provides significant health benefits for adults with obesity," said Dr Xavier Pi-Sunyer, Co-Director of The New York Obesity Nutrition Research Center and lead investigator of the trial. "The high proportion of adults achieving this clinically meaningful weight loss is encouraging, particularly when seen in combination with the additional benefits beyond weight loss that are also being evaluated with liraglutide 3mg treatment."

In conjunction with weight loss, treatment with liraglutide 3mg significantly reduced waist circumference by -8.19cm, compared to -3.94cm with placebo (p<0.0001). Furthermore, treatment with liraglutide 3mg improved blood glucose levels, blood pressure and lipids levels.

Side effects

The most frequently reported side effects associated with liraglutide 3mg treatment were gastrointestinal (nausea and diarrhoea), which were mild to moderate, occurred shortly after liraglutide initiation, and were transient. Incidences of gallbladder disorders and pancreatitis were low but higher than in placebo-treated individuals.

Gallbladder disorders were reported as 2.7 events per 100 patient-years of exposure (PYE) with liraglutide 3mg treatment compared to 1.0 events per 100 PYE for placebo and pancreatitis as 0.3 events per 100 PYE with liraglutide 3mg compared to 0.1 events per 100 PYE with placebo.

SCALE

The SCALE Obesity and Pre-diabetes trial is a randomised, double-blind, placebo-controlled, multinational trial in non-diabetic obese subjects and non-diabetic overweight subjects with co-morbidities. There were 3,731 participants randomised to treatment with liraglutide 3mg or placebo in combination with diet and exercise. In addition, participants were further stratified to 56 weeks or 160 weeks of treatment based on pre-diabetes status at screening.

The objectives of this trial were to demonstrate clinically meaningful weight loss at 56 weeks as well as investigate the long-term efficacy of liraglutide 3mg to delay the onset of type 2 diabetes in subjects with pre-diabetes status at screening.

This is the largest trial in the SCALE programme investigating liraglutide 3mg, which encompassed more than 5,000 participants who are obese or overweight with comorbidities.

In December 2013, Novo Nordisk submitted a Marketing Authorisation Application to the European Medicines Agency and a New Drug Application to the FDA for liraglutide 3mg for chronic weight management in adults who have obesity or are overweight with comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity. These applications are under review.

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