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Novo Nordisk’s Oral Semaglutide Lowers HbA1c in Teens in Pivotal Trial

The positive result sets up pediatric filings in both regions in the second half of 2026.

Overview

  • Novo Nordisk said Thursday that its PIONEER TEENS study showed a 0.83 percentage‑point greater drop in HbA1c versus placebo at 26 weeks.
  • The 52‑week, double‑blind trial enrolled 132 patients ages 10 to 17 who received once‑daily oral semaglutide or placebo while continuing metformin, basal insulin, or both.
  • The company reported a safety profile in youths that matched prior semaglutide studies in adults, and investigators described the pill as well tolerated.
  • Novo Nordisk plans to seek a pediatric label expansion in the U.S. and EU in the second half of 2026, and the medicine is not yet approved for children or adolescents.
  • If cleared, it would be the first oral GLP‑1 for young people with type 2 diabetes, adding a pill option where metformin often fails and insulin can cause low blood sugar and weight gain.