Repurposing of Endoscopic Injection of Botulinum Toxin A for Obesity Treatment in Adolescents

According to the AMA and the WHO, obesity can be considered a chronic disease and also leads to the development of other chronic diseases including diabetes. Obesity in adolescents is often difficult to treat by diet, physical activity and behavioural therapy. Gastric bypass surgery is very effective among adults, but is highly invasive and not recommended for children, leaving many obese adolescents without treatment options. Food intake is controlled by the brain. We have found that blocking neural communication between the stomach and brain, i.e. vagus nerve, by injecting Botulinum toxin A (Botox) into the stomach wall reduces food intake and results in weight loss in animals. Moreover, in a clinical trial of 20 obese adults, we found that this treatment was safe and led to clinically meaningful weight loss. We propose to perform a multi-national, randomised, double-blind, placebo-controlled phase II clinical trial to determine whether this treatment is also effective for obesity in adolescents. The overall objective of this project is to achieve clinical meaningful body weight loss in obese adolescents who show an inadequate response or are intolerant to lifestyle modification. With this trial, we hope to fill the treatment gap for the obese adolescents, thus protecting the health of our next generation. This project will be developed to respond to the Horizon 2020 call H2020-SC1-PM-09 'New therapies for chronic diseases'. At this stage of the project, the greatest challenge is to have sufficient time/capacity to 1) inform potential clinical partners and to get them on board with the project, 2) exploit available scientific expertise to ensure that the trial is properly designed and executed, and 3) write the application.