Novo Nordisk has announced that a peer-reviewed journal published the results of a phase 3 trial evaluating the investigational use of Saxenda in adolescents with obesity.
The study was accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting in San Francisco, US, and will be published in a supplemental issue of the Journal of the Endocrine Society.
Saxenda is currently indicated for chronic weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight-related comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity.
“We are encouraged by these results and the progress made to provide a treatment option for healthcare professionals caring for adolescents living with obesity,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “It’s vital that families affected by obesity have the tools and resources needed to address this health issue. These data add to the extensive evidence for the clinical use and value of Saxenda and support Novo Nordisk’s commitment to improving the lives of people with obesity.”
A post-marketing requirement of the FDA and the EMA
The trial was designed to evaluate the efficacy and safety of Saxenda in this population and achieved its primary endpoint demonstrating that Saxenda, compared with placebo, was superior in reducing Body Mass Index (BMI) standard deviation score (SDS) at 56 weeks with a -0.22 estimated treatment difference (ETD). BMI-SDS is a measure of relative weight status adjusted for age and gender in children and adolescents. The study was a post-marketing requirement of the FDA and the EMA in agreement with Paediatric Investigation Plan (PIP), both of which aim to ensure treatments are safe and effective for children and adolescents.
In the trial, following 56 weeks of treatment, there was a difference in change in BMI (kg/m2) with adolescents in the Saxenda arm achieving a 4.29% reduction in BMI, compared to a 0.35% increase with placebo. In addition, 43.3% of adolescents treated with Saxenda® had a 5%, or more, reduction in BMI at week 56 (compared to 18.7% on placebo) and 26.1% had a 10%, or more, reduction (compared to 8.1% with placebo).
There were no new safety signals identified, and no severe hypoglycaemias were reported, and adverse events were similar to those observed in adults. During the 56-week treatment period, 64.8% of adolescents on Saxenda reported gastrointestinal adverse events, compared to 36.5% of those receiving placebo. Three adolescents on Saxenda reported serious adverse events, versus five in the placebo group. A greater number of adolescents discontinued treatment due to adverse events with Saxenda (10.4%) compared to placebo (0%), primarily related to gastrointestinal side effects.
Photo of Mads Krogsgaard Thomsen: Novo Nordisk
