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

"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.