Novo Nordisk PIONEER TEENS Phase 3a Trial: Oral Semaglutide Shows Superior HbA1c Reduction in Children and Adolescents with Type 2 Diabetes
Novo Nordisk announced April 23 positive topline results from the PIONEER TEENS trial: a 52-week, randomized, double-blind, placebo-controlled Phase 3a study of oral semaglutide (3, 7, or 14 mg once daily) in 132 children and adolescents aged 10-17 with type 2 diabetes. Oral semaglutide reduced HbA1c by 0.83 percentage points more than placebo at 26 weeks with a well-tolerated safety profile. Pending regulatory approvals, it would be the first oral GLP-1 RA for this pediatric population. Novo expects to file for label expansion in the US and EU in H2 2026.