Novo Nordisk’s GLP-1 Agonist Demonstrates Significant BMI Reduction in Children Aged 6-12 in Phase 3 Trial

Significant BMI Reduction:
Novo Nordisk's GLP-1 agonist, liraglutide, showed a 7.4% reduction in BMI in children aged 6-12 over approximately a year in a Phase 3 trial.

Clinical Trial Details:
The trial involved 82 children who received either liraglutide or a placebo for 56 weeks, with lifestyle coaching sessions to discuss nutrition and physical activity.

Efficacy and Safety:
The medication was generally well tolerated, with gastrointestinal side effects being more prevalent among those receiving liraglutide. Almost half of the participants on liraglutide achieved a BMI reduction of at least 5%, compared to only 9% in the placebo group.

Regulatory Status:
Novo Nordisk has submitted a request to the FDA to broaden the approval of liraglutide for weight management in children aged 6-11.

Context:
The trial's findings are significant given the rising rates of childhood obesity, with one in five children aged 6-11 in the U.S. being classified as obese. The American Academy of Pediatrics has recommended weight loss medications and, in some cases, surgery for children aged 12 and older with severe obesity.

Long-term Implications:
There are concerns about the long-term effects of these medications on children's physical development, including potential risks to thyroid health and bone health.

Broader Use of GLP-1 Agonists:
GLP-1 agonists have been shown to be effective in promoting weight loss in both diabetic and non-diabetic patients, with semaglutide 2.4 mg being approved for chronic weight management in adults with obesity or overweight in June 2021.