Novo Nordisk STEP Young part 3 information: 40.4% of youngsters residing with weight problems achieved a BMI under the weight problems threshold with semaglutide and life-style modification

Data highlights

• The STEP Young part 3 trial met its major endpoint, demonstrating larger physique mass index (BMI) discount in kids aged 6 to underneath 12 handled with once-weekly subcutaneous semaglutide in contrast with placebo
• Both teams acquired life-style modification all through the trial, together with reduced-calorie weight-reduction plan and elevated bodily exercise
• 40.4%* of the kids handled with semaglutide had been now not categorized as having weight problems** after 68 weeks in contrast with non (0%) handled with placebo
• The general security and tolerability of semaglutide had been in keeping with these seen in adults and adolescents trials with semaglutide

Bagsværd, Denmark, 7 September 2026 – Novo Nordisk at this time introduced first outcomes from the STEP Young part 3 trial, evaluating once-weekly semaglutide together with a reduced-calorie weight-reduction plan and elevated bodily exercise in kids aged 6 to underneath 12 years outdated with weight problems. Obesity prevalence is rising on this age group, for whom there are restricted clinically examined and authorised therapies obtainable when life-style modifications will not be enough.

At baseline, greater than 85% of the kids had both class II or III extreme weight problems (equivalent to a BMI above or equal to 35 and 40 in adults, respectively). The trial met its major endpoint demonstrating superior BMI discount at week 68 within the group taking semaglutide in contrast with the placebo group. The outcomes confirmed that 40.4%* of these handled with semaglutide had been now not categorized as having weight problems** at week 68, in contrast with none of these handled with placebo. This signifies that semaglutide helped two out of 5 of the kids scale back their BMI to a standard weight or obese classification in contrast with not one of the kids within the placebo group. Both teams acquired life-style modification all through the trial, together with reduced-calorie weight-reduction plan and elevated bodily exercise.

“Childhood obesity is particularly concerning due to both immediate and enduring impacts on health, including a strong predilection to adult obesity and increased risk for the early emergence of obesity-related complications,” mentioned Ania M. Jastreboff, MD, PhD, Professor of Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology) on the Yale and Director of the Yale Obesity Research Center (Y-Weight). “Most of the children in the STEP Young trial were classified as having severe (class II or III) obesity at baseline, yet treatment with semaglutide resulted in a BMI percentile category below the obesity threshold in approximately 40% of the children within about a year of treatment,”

Children residing with weight problems expertise heart problems danger components, alongside melancholy, consuming problems, and bullying, with research exhibiting that their high quality of life is similar to kids present process most cancers remedy.^1-3 Without efficient intervention, childhood weight problems strongly tracks into maturity¹, the place obesity-related issues emerge earlier and extra severely,^1-3 considerably shortening life expectancy.⁴ An estimated 177 million kids aged 5 to 19 had been residing with weight problems in 2025, and this determine is projected to rise to 228 million by 2040.⁵

“For kids residing with weight problems and their households, well being challenges can start early and have an effect on wellbeing all through life,” mentioned Martin Holst Lange, govt vice chairman, chief scientific officer and head of Research & Development at Novo Nordisk. “As a pioneer in paediatric obesity medicine, we are encouraged by the positive STEP Young results and semaglutide’s potential to help children living with obesity who need medical treatment, alongside lifestyle changes, to better manage their obesity. This may prevent serious health risks later in life.”

The general security and tolerability of semaglutide noticed in STEP Young had been in keeping with earlier Novo Nordisk paediatric and grownup trials with semaglutide and liraglutide, and no new security considerations had been recognized. Furthermore, no security considerations had been recognized for progress or pubertal improvement.

Detailed STEP Young outcomes will likely be introduced at The Obesity Society’s annual assembly ObesityWeek 2026, 14-17 November in Washington DC, United States.

* Based on the trial product estimand: remedy impact if all kids adhered to remedy 
**Based on CDC.gov sex- and age-specific BMI progress charts. Using percentiles to outline BMI classes in kids is necessary as a result of they’re nonetheless rising. In kids, weight problems is outlined as a BMI at or above the ninety fifth percentile for age and intercourse. Obesity courses II and III in kids are outlined as a BMI ≥120% and ≥140% of the ninety fifth percentile, respectively.

About the STEP Young trial

The STEP Young trial is performed in line with regulatory authorities’ put up advertising necessities for the semaglutide scientific part 3 improvement program thus follows the part 3 outcomes of semaglutide 2.4 mg in adults and adolescents with weight problems.

The part 3 STEP Young is a randomised, double-blind, placebo-controlled, multinational trial investigating security and efficacy of semaglutide in contrast with placebo in 165 kids with weight problems aged 6 to <12 years, each together with reduced-calorie weight-reduction plan and elevated bodily exercise. The kids acquired a most dose of both 1.7 mg or 2.4 mg of semaglutide, primarily based on their weight at first of the trial.

Endpoint	Description	Population	Timepoint
Primary endpoint	Change in BMI (%) from baseline (week 0) to week 68	Children aged 6 to underneath 12 years	Week 68
Confirmatory secondary endpoint	Improvement in BMI classification** from baseline to week 68	Children aged 6 to underneath 12 years	Week 68
Supportive secondary endpoints	Changes in anthropometric measures, cardiovascular danger components, glucose metabolism, and physique composition (DXA subgroup)	Children aged 6 to underneath 12 years	Week 68 / Week 104

**Based on CDC.gov sex- and age-specific BMI progress charts. Using percentiles to outline BMI classes in kids is necessary as a result of they’re nonetheless rising. In kids, weight problems is outlined as a BMI at or above the ninety fifth percentile for age and intercourse. Obesity courses II and III in kids are outlined as a BMI ≥120% and ≥140% of the ninety fifth percentile, respectively.

About semaglutide
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that mimics the consequences of the naturally occurring hormone GLP-1, which regulates blood sugar and physique weight. Semaglutide has been examined in a number of strong scientific improvement programmes and consequence research in cardiometabolic illnesses, together with sort 2 diabetes, weight problems, heart problems, coronary heart failure, continual kidney illness, liver illness, and different associated cardiometabolic illnesses. Semaglutide is marketed underneath the model names Wegovy^® (injection or pill), Ozempic^® (injection or pill), and Rybelsus^® (pill).

About Novo Nordisk
Novo Nordisk is a number one world healthcare firm based in 1923 and headquartered in Denmark. Our objective is to drive change to defeat severe continual illnesses constructed upon our heritage in diabetes. We accomplish that by pioneering scientific breakthroughs, increasing entry to our medicines, and dealing to forestall and finally remedy illness. Novo Nordisk employs about 66,700 individuals in 80 international locations and markets its merchandise in round 170 international locations. For extra info, go to novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.  

Contacts for additional info

References

1. Hampl SE, Hassink SG, Skinner AC, et al. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics 2023; 151
2. Kumar S, Kelly AS. Review of Childhood Obesity: From Epidemiology, Etiology, and Comorbidities to Clinical Assessment and Treatment. Mayo Clin Proc 2017; 92: 251-65.
3. Schwimmer JB, Burwinkle TM, Varni JW. Health-related high quality of lifetime of severely overweight kids and adolescents. Jama 2003; 289: 1813-9.
4. Wiedemann UCH, van den Akker ELT, Barber TM, et al. Early-Onset of Obesity Model: Impact of Early-Onset Obesity on Comorbidity Risk and Life Expectancy. Obes Facts 2026; 19: 265-79.
5. World Obesity Federation. World Obesity Atlas 2026. Available at: (accessed August 2026)​

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