New data shows blood glucose, CV risk factors and quality of life outcomes improvement with Saxenda®
Posted: 9 March 2015 |
New data from the phase 3a SCALE™ Obesity and Prediabetes trial were presented at The Endocrine Society’s 97th Annual Meeting (ENDO), showing that adults with obesity or who are overweight with comorbidities who had lost ≥5% of their body weight at 56 weeks (ie weight loss responders), demonstrated greater improvements across a range of efficacy outcomes with Saxenda® (liraglutide 3 mg) treatment in combination with a reduced-calorie diet and increased physical activity…
New data from the phase 3a SCALE™ Obesity and Prediabetes trial were presented at The Endocrine Society’s 97th Annual Meeting (ENDO), showing that adults with obesity or who are overweight with comorbidities who had lost ≥5% of their body weight at 56 weeks (ie weight loss responders), demonstrated greater improvements across a range of efficacy outcomes with Saxenda® (liraglutide 3 mg) treatment in combination with a reduced-calorie diet and increased physical activity, compared with those that had a weight loss of <5% (ie non-responders).
In the SCALE™ Obesity and Prediabetes trial, 63.2% of adults achieved a clinically meaningful body weight reduction of at least 5% with Saxenda® compared with 27.1% on placebo (p<0.0001). The average weight loss for responders on Saxenda® treatment was 11.7% compared with 1.7% for non-responders. For placebo treatment, average weight loss in responders was 10.0% versus 0.1% weight gain in non-responders. Saxenda® treatment was associated with a greater reduction in waist circumference in responders, compared with non-responders (11.0 cm vs 3.3 cm).1
In addition to weight loss, improvements across a number of secondary endpoints were also observed in the responder population (Saxenda® and placebo). A greater improvement was seen in fasting plasma glucose (FPG) in Saxenda® responders compared with placebo responders (-8.3 vs -2.8 mg/dl, respectively) as well as non-responders (-5.0 vs +1.1 mg/dl, respectively). In addition, treatment with Saxenda® was associated with a greater reduction in systolic blood pressure (SBP) compared with placebo in both responders (-5.5 vs -3.4 mm Hg, respectively) and non-responders (-2.0 vs. -0.8 mm Hg, respectively). Improvements in physical health scores (as measured by the SF-36 questionnaire) were seen with Saxenda® and placebo responders (+4.3 vs +4.1 points, respectively) compared with non-responders (+2.1 vs +1.3 points, respectively).1
“These are important findings as they show that for adults with obesity or who are overweight with comorbidities, losing 5% to 10% of their body weight can help improve comorbidities, including fasting plasma glucose and blood pressure,” said Dr Patrick O’Neil, Professor of Psychiatry and Behavioral Sciences at the Medical University of South Carolina and SCALE™ clinical trial investigator. “Those who responded, losing 5% or more of their body weight, not only saw improvements in cardiometabolic risk factors but also in quality of life outcomes, compared with those who did not respond, for both liraglutide and placebo treatment.”
Across the SCALE™ clinical development programme, Saxenda® (liraglutide 3 mg) was generally well tolerated. The most common side effects observed were related to the gastrointestinal system. In the SCALE™ Obesity and Prediabetes trial, rates of adverse events were similar in both responders and non-responders. The number of adverse events leading to trial withdrawal was lower in responders compared with non-responders.1
- O’Neil P, Fujioka K, Violante Ortiz R, Claudius B, Jensen CB, Astrup A. Efficacy and safety of liraglutide 3.0 mg in adult overweight and obese weight loss responders without diabetes: the SCALE™ obesity and pre-diabetes, a randomized, double-blind and placebo-controlled trial. Paper presented at: ENDO 2015, The Endocrine Society’s 97th Annual Meeting (ENDO). 5–8 March 2015; San Diego, CA.
