Novo Nordisk reports positive phase 3a PIONEER TEENS results, with oral semaglutide achieving a 0.83% HbA1c reduction in adolescents with type 2 diabetes.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Novo Nordisk has reported positive topline results from the phase 3a PIONEER TEENS trial (NCT04596631)evaluating oral semaglutide in children and adolescents aged 10–17 years with type 2 diabetes. The study marks the first clinical evaluation of an oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) in this population.
The 52-week, randomized, double-blind, placebo-controlled trial included 132 participants who received once-daily doses of 3 mg, 7 mg, or 14 mg alongside background therapy with metformin, basal insulin, or both.
The trial met its primary endpoint, demonstrating a statistically significant, superior reduction in HbA1c of 0.83% versus placebo at week 26.
The treatment was well tolerated, with an adverse-event profile consistent with prior semaglutide studies and no new safety signals identified. Gastrointestinal events were the most common side effects, in line with the known class profile of GLP-1 RAs, supporting the feasibility of oral GLP-1 therapy in a paediatric population.
Novo Nordisk noted that these findings address a substantial unmet need, as current therapies such as metformin and insulin often fail to achieve adequate glycaemic control and may lead to hypoglycaemia and weight gain.
Martin Holst Lange chief scientific officer and executive vice president, Research & Development, at Novo Nordisk highlighted that the increasing prevalence of type 2 diabetes in young people, combined with limited treatment options, represents a significant clinical challenge. He added that the established efficacy and safety of oral semaglutide in adults, together with the PIONEER TEENS results, support its potential as a new option for improving glycaemic control in children and adolescents.
Global estimates suggest 14.6 million adolescents were living with type 2 diabetes in 2021, a figure projected to reach 20.9 million by 2030.
Oral semaglutide is currently approved in the EU and US as Rybelsus for adults with type 2 diabetes and is expected to launch in the US as an oral version of Ozempic in 2026. In adults, it has demonstrated robust glucose lowering along with benefits including weight reduction, improved cardiometabolic risk factors, and reduced major adverse cardiovascular events.
Novo Nordisk plans to pursue regulatory submissions in the US and EU in the second half of 2026 to expand its use to paediatric patients.
Reference
Novo Nordisk’s oral semaglutide demonstrates potential to be the first oral GLP-1 RA therapy for children and adolescents with type 2 diabetes, 23 April 2026, News Details
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.