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Novo Nordisk reports positive data from a post-hoc analysis of Phase IIIa Scale trial of Saxenda

Novo Nordisk has reported that new data from a post-hoc analysis of the phase 3a Scale clinical trial programme were presented at the European Congress on Obesity (ECO), demonstrating the weight-loss-dependent and independent effects of Saxenda (liraglutide 3 mg).

"For the first time, we have looked at the Scale clinical trial programme to explore to what degree the benefits of liraglutide 3 mg could be assigned to the drug itself, or to the effect of the weight loss a person may achieve while taking liraglutide 3 mg, the post-hoc analysis confirmed that weight loss has a positive impact on a number of cardiometabolic risk factors, including high blood pressure and cholesterol. However, importantly we also saw the direct effect of liraglutide 3 mg on glycaemic control and other endpoints, independent of weight loss." Said Professor Luc Van Gaal, head of the Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, and Scale trial investigator.

A mediation model was applied to determine weight-loss-dependent effects, with a score of 100% indicating full dependence. Endpoints primarily driven by weight loss (88-100%) included waist circumference, diastolic blood pressure, triglycerides, high density lipoprotein (HDL) cholesterol levels, apnoea-hypopnoea index (sleep apnoea severity), impact of weight on quality of life (IWQoL) total score and physical function score.

Endpoints which improved due to liraglutide 3 mg treatment, but were independent of weight loss (18-32%) included glycaemic endpoints (HbA1c and fasting plasma glucose), as well as a reduction in use of oral anti-diabetic treatments. However, reduction in bodyweight still contributed to these treatment effects.

Across the Scale clinical development programme, liraglutide 3 mg was generally well tolerated. The most common side effects observed were related to the gastrointestinal system.