Novo Nordisk reports positive STEP Young results in children aged 6 to under 12

Novo Nordisk announced first STEP Young Phase 3 results on 7 September 2026.

Trial design and outcome

The randomised, double-blind study involved 165 children aged 6 to under 12, comparing weekly semaglutide with placebo. Both groups received diet and physical-activity support.

The trial met its primary endpoint of superior BMI reduction after 68 weeks. The company reports that 40.4% of semaglutide-treated participants fell below the childhood-obesity threshold, compared with 0% on placebo.

That percentage uses the trial-product estimand, estimating the effect if participants adhered to treatment. It should not be interpreted as an unconditional real-world success rate.

Safety and next evidence

Novo reports no new safety concerns, including for growth or pubertal development. A study of this size and duration cannot resolve every longer-term question.

Detailed results are planned for ObesityWeek, 14–17 November. Today's release does not give the numerical primary-endpoint BMI difference or announce a new approval for this age group.

The commercial significance depends on the full data, regulatory decisions and subsequent access, rather than the topline result alone.

Source: Company announcement, 7 September 2026.