Novo Nordisk Trial Shows Promising Weight Loss Results for Children Aged 6-12

Novo Nordisk has announced encouraging preliminary results from a Phase 3 clinical trial, STEP Young, investigating the use of semaglutide, the active ingredient in Wegovy and Ozempic, for weight loss in children aged 6 to 12. The study, which included 165 children with obesity, found that 40% of those who completed 68 weeks of treatment with semaglutide were no longer classified as obese, compared to none in the placebo group. Both groups also received lifestyle interventions, including diet and exercise.

While the results are promising, they come with caveats. The 40% figure assumes full treatment adherence, which may not reflect real-world outcomes. Over 85% of participants had severe obesity (BMI of 35 or higher) at the study's start. The trial met its primary endpoint, showing a statistically significant reduction in BMI for the semaglutide group compared to placebo. Novo Nordisk reported that the safety and tolerability profile of semaglutide in this trial was consistent with previous studies in adults and adolescents, with no new safety concerns identified, including those related to growth and sexual development.

The trial employed a rigorous double-blind, placebo-controlled design. In Israel, Wegovy is available for adolescents meeting specific criteria but is not approved for children under 12. This trial's findings reflect a broader trend of increasing prescriptions for GLP-1 drugs among younger age groups, even where not officially approved. A separate US study published in Pediatrics indicated a 310-fold increase in prescriptions for these drugs among children aged 8-11 since 2019, though the overall percentage remains low at about 0.6%.

Researchers analyzed data from over 3.5 million obese children aged 8-11 without diabetes. While not approved for those under 12, some clinical guidelines permit off-label use for children as young as eight in specific cases. The US study also noted that 94% of children prescribed GLP-1 drugs had severe obesity, and about 65% had at least one comorbidity like high cholesterol, high blood pressure, or sleep apnea. Experts emphasize the need for long-term monitoring of these drugs' safety and efficacy as their use expands.