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New study shows that semaglutide helped 40% of obese children to reduce BMI
09/30/2026 | Priscila Torres | BioRed Brasil
- The phase 3 STEP Young study investigated its primary disability, demonstrating a greater reduction in body mass index (BMI) in children from 6 to 12 years of age treated with subcutaneous semaglutide once a week compared to placebo.
- 40.4%* of the children treated with semaglutide were classified as obese** after 68 weeks, in comparison with non-human (0%) children treated with placebo.
- Both groups received lifestyle interventions throughout the study, including a calorie-reduced diet and increased physical activity.
- The general safety and tolerability profile of semaglutide was consistent as observed in studies with adults and adolescents treated with semaglutide.
- In Brazil, Wegovy® (semaglutide 2.4 mg weekly) and Saxenda® (liraglutide) are the only medications approved for the treatment of obesity in adolescents from 12 years of age, associated with lifestyle changes.
We recently announced the first results of the STEP Young phase 3 study, which evaluated semaglutide administered once a week in combination with a low-calorie diet and increased physical activity in children from 6 to under 12 years of age with obesity. The prevalence of obesity is increasing in age and there are few clinically validated and approved treatment options when lifestyle changes are not sufficient.
At the beginning of the study, more than 85% of children present severe obesity of class II or III (corresponding, respectively, to a BMI greater than or equal to 35 and 40 in adults). The study investigated its primary defect to demonstrate a superior reduction in BMI at week 68 in the semaglutide-treated group in comparison to the placebo group.
The results will show that 40.4%* of children treated with semaglutide were classified as obese** at week 68, in comparison with children treated with placebo. This means that semaglutide helped every five children to reduce their BMI for a classification of normal weight or overweight, while in children in the placebo group they achieved this result. Both groups received lifestyle interventions throughout the study, including a calorie-reduced diet and increased physical activity.
“Childhood obesity is particularly worrisome due to its immediate and long-term impacts on health, including a strong tendency toward obesity persistence in adulthood and the increased risk of early emergence of obesity-related complications,” said Ania M. Jastreboff, MD, PhD, Professor of Medicine (Endocrinology) and Pediatrics. (Pediatric Endocrinology) at Yale University and director of the Yale Obesity Research Center (Y-Weight). "The majority of the children participating in the STEP Young study presented severe obesity (class II or III) at the beginning of the study. Thus, the treatment with semaglutide resulted in a BMI percentile category below the limit of obesity in approximately 40% of the children after approximately one year of treatment."
Children who live with obesity present risk factors for cardiovascular diseases, as well as depression, eating disorders and episodes of bullying. Studies show that their quality of life is comparable to that of children in cancer treatment.¹⁻³ Without an effective intervention, childhood obesity tends strongly to persist in adult life¹, a period in which complications related to obesity arise earlier and more seriously,¹⁻³ substantially reducing life expectancy.⁴ It is estimated that 177 million children between 5 and 19 years old will live with obesity in 2025, and this number should increase to 228 million by 2040.⁵
“For children who live with obesity and their families, health challenges can begin to impact and last a lifetime,” said Martin Holst Lange, executive vice president, scientific director and responsible for New Research and Development. "As a pioneer in pediatric obesity medicine, we are encouraged by the positive results of STEP Young and the potential of semaglutide to help children who live with obesity and need medication treatment, combined with lifestyle changes, to better control their condition. This can contribute to preventing serious risks to health later in life."
The general safety and tolerability profile of semaglutide observed in STEP Young was consistent with the pediatric and adult studies previously carried out for new semaglutide and liraglutide, without identification of new safety signs. Also, there are no observed concerns related to growth or pubertal development.
The detailed results of STEP Young will be presented during ObesityWeek 2026, annual meeting of The Obesity Society, held from November 14 to 17, 2026, in Washington, D.C., United States.
* Based on the estimation of the product in research: treatment effect considering that all children are subject to treatment.
**Based on the CDC's sex- and city-specific BMI growth charts. The use of percentis to define BMI categories in children is important because they are still in the growth phase. In children, obesity is defined as BMI equal to or greater than the 95th percentile for age and sex. Classes II and III of obesity in children are defined as BMI ≥120% and ≥140% of the 95th percentile, respectively.
About the STEP Young study
The STEP Young study was conducted in attention to the post-commercialization requirements of the regulatory authorities for the phase 3 clinical development program of semaglutide and the results of phase 3 of semaglutide 2.4 mg in adults and adolescents with obesity.
STEP Young is a multinational phase 3, randomized, double-blind and placebo-controlled study that supports the safety and effectiveness of semaglutide in comparison with placebo in 165 obese children, from 6 to under 12 years of age, both associated with a diet with caloric reduction and increased physical activity. Children will receive a maximum dose of 1.7 mg or 2.4 mg of semaglutide, determined according to their weight at the beginning of the study.
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**Based on the CDC's sex- and city-specific BMI growth charts. The use of percentis to define BMI categories in children is important because they are still in the growth phase. In children, obesity is defined as BMI equal to or greater than the 95th percentile for age and sex. Classes II and III of obesity in children are defined as BMI ≥120% and ≥140% of the 95th percentile, respectively.
About semaglutide
Semaglutide is a glucagon-like peptide receptor agonist (GLP-1) that reproduces the effects of the natural hormone GLP-1, responsible for regulating blood glucose and body weight. Semaglutide has been evaluated in several robust clinical development programs and studies of defects in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease, and other related cardiometabolic conditions.
Semaglutide is marketed under the brands Wegovy® (injetável), Ozempic® (injetável) and Rybelsus® (tablet).
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