Obesity: liraglutide 3 mg confirms its efficacy in reducing body weight and improving blood glucose control

New data from the SCALE™ study show results regardless of the degree of overweight or obesity at the start of treatment: weight reduction is about 3 times greater than placebo; almost double the percentage of people returning to normal blood glucose values.

Rome, Oct. 3, 2016 – No matter whether overweight or obesity at various levels of severity: liraglutide proves effective in reducing body weight and improving blood glucose control. This is shown by data, the result of three years of study, presented at the 8th National Congress of the Italian Obesity Society (SIO), which concluded over the weekend in Rome.

Results from a post hoc analysis of the phase 3a SCALE™ (Satiety and Clinical Adiposity – Liraglutide Evidence) study show that people treated for 160 weeks with liraglutide 3 mg (Saxenda) had consistent weight loss and improved glycemic control, regardless of the degree of overweight or obesity at the start of treatment, compared with placebo.

The study involved adults with prediabetes and obesity or overweight with comorbidities who were randomized to receive liraglutide (n=1.505) or placebo (n=749) for 160 weeks, both in addition to low-calorie diet and increased physical activity. 1

"This is, at the moment, the longest-running weight management study with liraglutide 3 mg, and the results further reinforce the drug’s efficacy and safety across a key spectrum of parameters for the management of the obese patient; very positive, in particular, were the data on the maintenance of the effect across all body mass index ranges, both for weight reduction and improvement in all glyco-metabolic parameters," commented Paolo Sbraccia, president of the Italian Obesity Society (SIO).

Blood glucose, weight loss, and overall safety profile were analyzed in the study. Depending on body mass index (BMI, an indicator that considers weight and height to identify the degree of obesity), people enrolled in the study were classified as: overweight (BMI 27-29 kg/m 2 ), class 1 obesity (BMI 30-34.9 kg/m 2 ), class 2 obesity (BMI 35-39.9 kg/m 2 ), and class 3 and higher obesity (BMI ≥40 kg/m 2 ). People treated with liraglutide showed consistent weight loss in all BMI categories: 5.7%, BMI 27-29.9 kg/m 2 ; 6.5%, BMI 30-34.9 kg/m 2 ; 6.2%, BMI 35-39.9 kg/m 2 ; 5.9%, BMI ≥40 kg/m 2 compared with 1.8%, 1.7%, 1.8% and 2.1% in the same categories treated with placebo. The percentage of people who returned to normal blood glucose values after 160 weeks of liraglutide treatment was similar: 67%, 67%, 70%, and 63% in each of the BMI categories, respectively, and significantly higher than 36%, 34%, 40%, and 33% with placebo (p<0.05). 1

In addition, in all BMI categories, significant improvements in: glycated hemoglobin (HbA_1c), fasting blood glucose, fasting insulin, beta-cell function, and insulin resistance. 1

"The 3-year results of the SCALE™ study in patients with overweight or obesity and prediabetes treated with lifestyle modification and liraglutide are important in at least two aspects," he said Luca Busetto, associate professor of internal medicine, Department of Medicine, University of Padua, Italy. "First, they demonstrate unequivocally that the greater weight loss achieved with drug therapy, in this particular group of patients, allows a greater metabolic benefit, in terms of return to normal glycemia and prevention of progression to diabetes. Second, the fact that the results are substantially similar in the different BMI classes confirms that the choice of the’intensity of therapy in the patient with obesity should be guided more by the clinical picture than by the extent of weight excess. I believe that both of these messages may be relevant to the daily clinical practice of clinicians involved in the treatment of’obesity," concludes.

The incidence of total and serious side effects, gastrointestinal disturbances, and hypoglycemia was similar in all BMI categories. 1 Liraglutide was generally well tolerated, consistent with previous studies.

Liraglutide 3 mg

Liraglutide 3 mg (Saxenda ® ), an injectable drug to be used once daily for the treatment of obesity, is a GLP-1 (glucagon-like peptide-1) analogue that is 97 percent similar to endogenous GLP-1 2 , a hormone that is released in response to’food intake 3 . Like human GLP-1, liraglutide 3 mg regulates appetite by promoting satiety and decreasing hunger and food cravings, thereby reducing food intake. As with other GLP-1 receptor agonists, it stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner 2 .

Liraglutide 3 mg has been evaluated in the SCALE™ (Satiety and Clinical Adiposity-Liraglutide Evidence in Nondiabetic and Diabetic people), a phase 3 clinical trial program.

In Europe, liraglutide 3mg is indicated in combination with hypocaloric diet and increased physical activity for weight management in adult patients with a body mass index greater than or equal to 30 kg/m 2 (obese), or greater than or equal to 27 kg/m 2 and less than <30 kg/m 2 (overweight) in the presence of at least one other weight-related comorbidity such as dysglycemia (prediabetes or type 2 diabetes), hypertension, dyslipidemia or sleep apnea 2 .

The Summary of Product Characteristics recommends discontinuing treatment if a 5% weight reduction is not achieved after 16 weeks of treatment 2 .