New Data on Saxenda® Show Early Response Predicts Improvements in Weight Loss and Cardiometabolic Risk Factors

STOCKHOLM, Sweden, September 15, 2015 /PRNewswire/ --





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Abstract #645

Today, new data from a post-hoc analysis of the phase 3a SCALE(TM) clinical development programme were presented at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting.[1] The data demonstrated that adults in the SCALE(TM) Obesity and Prediabetes and SCALE(TM) Diabetes trials who lost at least 5% of their body weight after completing 16 weeks of Saxenda(R) (liraglutide 3 mg) treatment (defined as 'early responders') had greater weight loss after completing 56 weeks, compared with people losing less than 5% body weight with Saxenda(R) after completing 16 weeks ('early non-responders'). All treatment groups included a reduced-calorie diet and increased physical activity.[1]

"These data demonstrate the importance of identifying those adults who respond early to Saxenda(R)," said Professor Matthias Blüher, head of the obesity outpatient clinic at the University of Leipzig, Germany, and SCALE(TM) trial investigator. "Not only are these Saxenda(R) early responders more likely to achieve greater weight loss over time, they are also more likely to experience greater improvements in cardiometabolic risk factors."

After completing 16 weeks of the SCALE(TM) Obesity and Prediabetes trial, 67.5% of adults with obesity or who were overweight with weight-related comorbidities (excluding type 2 diabetes), were early responders to Saxenda(R) (n=2487) and experienced an average weight loss of 11.5% after completing 56 weeks of treatment, compared with a weight loss of 3.8% for early non-responders. The proportion of early responders losing greater than or equal to5%, >10% and >15% of their bodyweight after completing 56 weeks was 88.2%, 54.8% and 24.2% respectively (36.9%, 8.3% and 1.8% respectively for early non-responders).

After completing 16 weeks of the SCALE(TM) Diabetes trial, 50.4% of adults with obesity or who were overweight and had type 2 diabetes, were early responders to Saxenda (R) (n=423), with a mean weight loss of 9.3% after completing 56 weeks of treatment compared with a weight loss of 3.6% for early non-responders. The proportion of early responders experiencing greater than or equal to5%, >10% and >15% weight loss after completing 56 weeks was 80.1%, 44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early non-responders).[1]

Across both trials, early responders demonstrated greater improvements in cardiometabolic risk factors, including blood pressure, cholesterol and triglycerides, compared to early non-responders.[1]

The overall safety profile was generally comparable between early responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events (related to the liver and/or the gallbladder) were higher in early responders compared with early non-responders in the SCALE(TM) Obesity and Prediabetes trial (3.5% vs 2.1% respectively).[1] In people with obesity or who were overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in both early responders and early non-responders (1.1% vs. 0.6% respectively) and all cases were in people who were taking prescribed sulfonylureas.

About obesity 

Obesity is a disease[2] that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy.[3],[4] Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.[3],[5],[6] It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.[7]      

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the EU, obesity affects approximately 10-30% of adults.[8]

About Saxenda(R)  

Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.[9] Like human GLP-1, Saxenda(R) regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.[10] These effects can lead to a reduction of fasting and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme.

Saxenda(R) was granted European marketing authorisation on 23 March 2015 by the European Commission (EC). In the EU, Saxenda(R) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of greater than or equal to30 kg/m2 (obese), or greater than or equal to27 kg/m2 to 10% and >15% of their bodyweight after completing 56 weeks was 88.2%, 54.8% and 24.2% respectively (36.9%, 8.3% and 1.8% respectively for early non-responders).

After completing 16 weeks of the SCALE(TM) Diabetes trial, 50.4% of adults with obesity or who were overweight and had type 2 diabetes, were early responders to Saxenda (R) (n=423), with a mean weight loss of 9.3% after completing 56 weeks of treatment compared with a weight loss of 3.6% for early non-responders. The proportion of early responders experiencing greater than or equal to5%, >10% and >15% weight loss after completing 56 weeks was 80.1%, 44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early non-responders).[1]

Across both trials, early responders demonstrated greater improvements in cardiometabolic risk factors, including blood pressure, cholesterol and triglycerides, compared to early non-responders.[1]

The overall safety profile was generally comparable between early responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events (related to the liver and/or the gallbladder) were higher in early responders compared with early non-responders in the SCALE(TM) Obesity and Prediabetes trial (3.5% vs 2.1% respectively).[1] In people with obesity or who were overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in both early responders and early non-responders (1.1% vs. 0.6% respectively) and all cases were in people who were taking prescribed sulfonylureas.

About obesity 

Obesity is a disease[2] that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy.[3],[4] Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.[3],[5],[6] It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.[7]      

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the EU, obesity affects approximately 10-30% of adults.[8]

About Saxenda(R)  

Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.[9] Like human GLP-1, Saxenda(R) regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.[10] These effects can lead to a reduction of fasting and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme.

Saxenda(R) was granted European marketing authorisation on 23 March 2015 by the European Commission (EC). In the EU, Saxenda(R) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of greater than or equal to30 kg/m2 (obese), or greater than or equal to27 kg/m2 to 15% of their bodyweight after completing 56 weeks was 88.2%, 54.8% and 24.2% respectively (36.9%, 8.3% and 1.8% respectively for early non-responders).

After completing 16 weeks of the SCALE(TM) Diabetes trial, 50.4% of adults with obesity or who were overweight and had type 2 diabetes, were early responders to Saxenda (R) (n=423), with a mean weight loss of 9.3% after completing 56 weeks of treatment compared with a weight loss of 3.6% for early non-responders. The proportion of early responders experiencing greater than or equal to5%, >10% and >15% weight loss after completing 56 weeks was 80.1%, 44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early non-responders).[1]

Across both trials, early responders demonstrated greater improvements in cardiometabolic risk factors, including blood pressure, cholesterol and triglycerides, compared to early non-responders.[1]

The overall safety profile was generally comparable between early responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events (related to the liver and/or the gallbladder) were higher in early responders compared with early non-responders in the SCALE(TM) Obesity and Prediabetes trial (3.5% vs 2.1% respectively).[1] In people with obesity or who were overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in both early responders and early non-responders (1.1% vs. 0.6% respectively) and all cases were in people who were taking prescribed sulfonylureas.

About obesity 

Obesity is a disease[2] that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy.[3],[4] Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.[3],[5],[6] It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.[7]      

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the EU, obesity affects approximately 10-30% of adults.[8]

About Saxenda(R)  

Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.[9] Like human GLP-1, Saxenda(R) regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.[10] These effects can lead to a reduction of fasting and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme.

Saxenda(R) was granted European marketing authorisation on 23 March 2015 by the European Commission (EC). In the EU, Saxenda(R) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of greater than or equal to30 kg/m2 (obese), or greater than or equal to27 kg/m2 to 10% and >15% weight loss after completing 56 weeks was 80.1%, 44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early non-responders).[1]

Across both trials, early responders demonstrated greater improvements in cardiometabolic risk factors, including blood pressure, cholesterol and triglycerides, compared to early non-responders.[1]

The overall safety profile was generally comparable between early responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events (related to the liver and/or the gallbladder) were higher in early responders compared with early non-responders in the SCALE(TM) Obesity and Prediabetes trial (3.5% vs 2.1% respectively).[1] In people with obesity or who were overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in both early responders and early non-responders (1.1% vs. 0.6% respectively) and all cases were in people who were taking prescribed sulfonylureas.

About obesity 

Obesity is a disease[2] that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy.[3],[4] Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.[3],[5],[6] It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.[7]      

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the EU, obesity affects approximately 10-30% of adults.[8]

About Saxenda(R)  

Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.[9] Like human GLP-1, Saxenda(R) regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.[10] These effects can lead to a reduction of fasting and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme.

Saxenda(R) was granted European marketing authorisation on 23 March 2015 by the European Commission (EC). In the EU, Saxenda(R) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of greater than or equal to30 kg/m2 (obese), or greater than or equal to27 kg/m2 to 15% weight loss after completing 56 weeks was 80.1%, 44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early non-responders).[1]

Across both trials, early responders demonstrated greater improvements in cardiometabolic risk factors, including blood pressure, cholesterol and triglycerides, compared to early non-responders.[1]

The overall safety profile was generally comparable between early responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events (related to the liver and/or the gallbladder) were higher in early responders compared with early non-responders in the SCALE(TM) Obesity and Prediabetes trial (3.5% vs 2.1% respectively).[1] In people with obesity or who were overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in both early responders and early non-responders (1.1% vs. 0.6% respectively) and all cases were in people who were taking prescribed sulfonylureas.

About obesity 

Obesity is a disease[2] that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy.[3],[4] Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.[3],[5],[6] It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.[7]      

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the EU, obesity affects approximately 10-30% of adults.[8]

About Saxenda(R)  

Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.[9] Like human GLP-1, Saxenda(R) regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.[10] These effects can lead to a reduction of fasting and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme.

Saxenda(R) was granted European marketing authorisation on 23 March 2015 by the European Commission (EC). In the EU, Saxenda(R) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of greater than or equal to30 kg/m2 (obese), or greater than or equal to27 kg/m2 to

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