On 7 September 2026, Novo Nordisk reported first results from the STEP Young phase 3 Kids cohort. The company said once-weekly subcutaneous semaglutide produced a greater percent BMI reduction at week 68 than placebo in children aged 6 to under 12 years with obesity. Both arms also received lifestyle modification: a reduced-calorie diet and increased physical activity.
The headline secondary figure is 40.4% of semaglutide-treated children no longer classified as having obesity at week 68, versus 0% on placebo. That 40.4% is the trial-product estimand: the treatment effect if all children adhered. It is a company topline, not a peer-reviewed manuscript and not an FDA approval for ages 6 to 11.
Wegovy (semaglutide) is already labeled in the United States for chronic weight management in adults and in pediatric patients aged 12 years and older, with diet and activity. The same label says safety and effectiveness have not been established for long-term weight reduction in patients younger than 12 years. STEP Young does not change that sentence.
What happened
The 7 September 2026 Novo Nordisk release, carried through GlobeNewswire and Ritzau, is the source for the Kids topline. The same release PDF is the attachment. Novo's homepage teaser used the same 7 September 2026 headline.
Company facts from that release:
- The phase 3 trial met its primary endpoint: greater percent BMI reduction from baseline to week 68 versus placebo.
- The reported Kids cohort is 165 children aged 6 to under 12 years with obesity.
- More than 85% had class II or class III severe obesity at baseline (BMI at or above 120% or 140% of the 95th percentile).
- Children received a maximum of 1.7 mg or 2.4 mg once weekly, assigned by weight at the start of the trial.
- 40.4% of children on semaglutide were no longer classified as having obesity at week 68, versus none (0%) on placebo. The company reads that as about two in five moving to a normal-weight or overweight classification.
- Obesity in children is defined as BMI at or above the 95th percentile for age and sex on CDC charts.
- Overall safety and tolerability were described as consistent with prior paediatric and adult semaglutide and liraglutide trials. The company said no new safety concerns were identified, including for growth or pubertal development.
- Detailed results are planned for ObesityWeek 2026, 14 to 17 November, in Washington, DC.
- The program is framed as a post-marketing requirement after the adult and adolescent 2.4 mg phase 3 work.
The release does not publish the primary percent-BMI-change numbers, p-values, per-arm counts, or a gastrointestinal adverse-event table. Those details are reserved for the November meeting.
Why it matters
Approved pharmacologic options for obesity in children under 12 are limited. The current U.S. Wegovy label covers ages 12 and older for weight reduction. A positive Kids phase 3 topline is the first company readout that semaglutide, with lifestyle, moved BMI class in a randomized 6-to-under-12 cohort of this size.
That is a development signal, not a prescribing change. Pediatric obesity still tracks into adulthood. The release cites that context. Tracking is not a claim that this trial already proved adult-complication prevention. Week-68 BMI class is the measured claim.
For PeptidePrices readers, the molecule is the same weekly GLP-1 receptor agonist already compared on the semaglutide listings and research profile. A pediatric Kids topline does not turn a research-vendor vial into Wegovy, and it does not extend the U.S. label below age 12.
Trial design and who was enrolled
ClinicalTrials.gov NCT05726227 is protocol NN9536-4512, acronym STEP Young. Novo Nordisk A/S is the sponsor. The study is interventional phase 3, randomized, parallel-group, and quadruple-masked (participant, care provider, investigator, and outcomes assessor). The official title covers children and adolescents aged 6 to under 18 years with obesity or overweight.
The trial has two groups. This article is about the Kids topline Novo announced on 7 September 2026. Group Teens (12 to under 18) is registered on the same protocol. The company release did not publish a Teens efficacy package.
| Item | Company press (7 Sep 2026) | Registries (NCT05726227 and CTIS) |
|---|---|---|
| Population announced | Children 6 to under 12 with obesity | Group Kids: 6 to under 12, BMI at or above the 95th percentile. Group Teens: 12 to under 18 |
| N | 165 children in the reported Kids cohort | Estimated or planned enrollment 210 for the whole trial (Kids plus Teens). Not listed as actual 165 |
| Design | Randomized, double-blind, placebo-controlled, multinational | Same, plus quadruple masking on ClinicalTrials.gov |
| Lifestyle | Reduced-calorie diet and increased physical activity in both arms | Same adjunct in both Groups |
| Primary (Kids) | Change in BMI (%) from week 0 to week 68 | Same Kids primary |
| Key secondary published | 40.4% vs 0% no longer classified as having obesity at week 68 (trial-product estimand) | Confirmatory secondary: improvement in CDC weight category, week 0 to week 68 |
| Status | First Kids results announced | ACTIVE_NOT_RECRUITING. Primary completion 15 October 2025 (actual). Completion estimated 7 December 2026. No results posted |
EU CTIS 2022-502922-41-00 matches the protocol number and lists 210 participants planned. Status there is ongoing, recruitment ended. ClinicalTrials.gov last updated the record on 7 August 2026, before this topline.
Kids inclusion on the registry also requires body weight above 45 kg and at least one unsuccessful structured lifestyle program of at least three months. Those criteria are protocol facts. They are not extra efficacy numbers.
Company topline versus the registries
The 165 figure and the 40.4% versus 0% pair come from the company. The 210 figure comes from the live registries as estimated or planned total enrollment for Kids plus Teens. This article does not collapse 165 and 210 into one N. If later papers report a different Kids randomized count, use that paper.
Dose language also splits by source. Prefer the press for the topline statement: a maximum of 1.7 mg or 2.4 mg once weekly based on weight at baseline. ClinicalTrials.gov describes Group Kids dose escalation toward maintenance: 0.25 mg (weeks 0 to 4), 0.5 mg (weeks 5 to 8), 1.0 mg (weeks 9 to 12), and 1.7 mg (weeks 13 to 16), then 2.4 mg as the listed maintenance for 88 weeks, as an adjunct to diet and activity. That is the registered escalation schedule. It is not a consumer schedule, and it is not the press's weight-banded maximum.
Supportive secondaries on both the press table and the registry include anthropometric measures, cardiovascular risk factors, glucose metabolism, and DXA body composition in a subgroup, at week 68 and week 104. None of those supportive numbers were in the 7 September release.
| Endpoint class | What was disclosed on 7 September 2026 | What was not |
|---|---|---|
| Primary | Met. Greater percent BMI reduction at week 68 vs placebo | The actual percent-BMI-change figures |
| Confirmatory secondary | 40.4% vs 0% below the obesity threshold (trial-product estimand) | Treatment-regimen or ITT pair, if one exists |
| Safety | Class-consistent language. No new concerns named, including growth and puberty | Event counts, discontinuations, hypoglycemia table |
| Teens | Not in this release | Any 12-to-under-18 efficacy package |
| Manuscript | Planned for ObesityWeek, 14 to 17 November 2026 | A DOI or peer-reviewed table |
The trial-product estimand is an adherence assumption. It answers a different question than a treatment-regimen analysis that keeps discontinuations in the estimate. The release does not publish that second estimand. Do not treat 40.4% as a real-world share of clinic patients.
What the current Wegovy label already says
The FDA Wegovy label (NDA 215256, supplement 024, revised August 2025) already lists semaglutide, with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults and in pediatric patients aged 12 years and older with obesity. Adults with overweight plus a weight-related comorbid condition are also on that indication.
Section 8.4 states that safety and effectiveness have not been established to reduce excess body weight and maintain weight reduction long term in pediatric patients less than 12 years of age. The Medication Guide repeats that it is not known whether Wegovy is safe and effective for long-term weight loss in children under 12 years.
STEP Young is the post-marketing Kids study Novo said regulators required after the adult and adolescent 2.4 mg phase 3 program. A required study can read out positive and still leave the under-12 indication unestablished until FDA reviews a complete package. This topline is not that review.
The labeled pediatric evidence that already exists is a different trial: a 68-week study in 201 pubertal patients aged 12 years and older. Do not merge STEP TEENS, STEP Young Kids, and that labeled 12-and-older trial into one N.
Limitations
This is a sponsor topline. There is no peer-reviewed Kids manuscript in this source set. ObesityWeek is a planned presentation, not a published paper.
The primary percent BMI change is not in the release. Readers who need the magnitude, confidence intervals, and the analysis set should wait for the November data or a journal article.
The 40.4% figure is one estimand. Adherence-as-if-all-completed is not the same as the share of children who would stay on weekly injections in ordinary care. Lifestyle ran in both arms, so the contrast is semaglutide plus lifestyle versus placebo plus lifestyle.
Enrollment bookkeeping is incomplete on the public registries. ClinicalTrials.gov still shows 210 estimated. CTIS still shows 210 planned. The press's 165 is the Kids figure Novo chose to announce. Actual randomized Kids and Teens splits are not posted as results.
Safety language is qualitative. "Consistent with prior trials" and "no new safety concerns" are company statements. They are not a substitute for the adverse-event tables that usually accompany a full pediatric obesity readout.
Growth and puberty were called out as having no identified safety concerns. That is still a company sentence. Height velocity, Tanner staging, and bone-density tables were not published on 7 September.
What this does not mean
- It is not FDA approval for children under 12. Wegovy's U.S. weight-reduction indication remains ages 12 and older. The label still says safety and effectiveness are not established under age 12.
- It is not a peer-reviewed full manuscript. The 7 September text is a company topline. Novo pointed to ObesityWeek 2026 for detail.
- It is not a consumer dosing protocol for kids. The 1.7 mg and 2.4 mg maxima, and the registry escalation steps, are trial-design facts. Nothing here is a schedule to copy.
- 40.4% is not a real-world guarantee. It is the trial-product estimand (the effect if all children adhered). The release does not publish a treatment-regimen pair.
- Lifestyle was in both arms. The control is not "no intervention."
- It does not change current U.S. Wegovy labeling for ages 12 and older. Adult, adolescent, cardiovascular, and MASH indications on the August 2025 label are separate from this Kids topline.
- It is not a Teens readout. Group Teens remains on the same protocol. Those results were not in this announcement.
- It is not a research-vendor product story. STEP Young used a controlled investigational or labeled-product supply in a randomized trial. Catalog semaglutide is a different market.
- This is not medical advice.
What to watch
- ObesityWeek 2026 (14 to 17 November, Washington, DC). The missing primary BMI-change figures, estimand pair, safety tables, and growth or puberty detail should appear there if Novo follows the release.
- A peer-reviewed Kids paper. A DOI would let readers check analysis sets against the 165 and 40.4% claims.
- Whether FDA opens or updates an under-12 review. Topline is not a label supplement.
- Registry cleanup. Watch whether NCT05726227 and CTIS replace 210 estimated or planned with actual Kids and Teens counts, and whether results post after the remaining 104-week and safety follow-up.
- The Teens package. Same protocol, different age band, already on the U.S. label for a different trial.
- How the 40.4% is restated. If a later paper reports a treatment-regimen percentage, that number will not replace the trial-product headline unless the paper says so.
Related incretin coverage on this site stays on its own molecules and trials: the ADA 2026 GLP-1 pipeline roundup, GLP-1s beyond weight loss, and survodutide SYNCHRONIZE. Those pages are not STEP Young.
FAQs
Did FDA approve Wegovy for children aged 6 to 11?
No. The August 2025 Wegovy label covers weight reduction in patients aged 12 years and older. It states that safety and effectiveness have not been established under age 12. STEP Young is a company phase 3 topline, not that approval.
What did STEP Young show?
Novo said the Kids cohort met the primary endpoint of greater percent BMI reduction at week 68 versus placebo, with lifestyle in both arms. 40.4% of children on semaglutide were no longer classified as having obesity, versus 0% on placebo, on the trial-product estimand. The primary percent-change numbers were not published.
How many children were in the trial?
The company reported 165 children aged 6 to under 12. ClinicalTrials.gov and CTIS still list about 210 as estimated or planned enrollment for the whole trial, which also includes Group Teens. Those figures are not the same N.
What dose was studied?
The press said the maximum was 1.7 mg or 2.4 mg once weekly, based on baseline weight. ClinicalTrials.gov describes a 16-week escalation toward a listed 2.4 mg maintenance. Those are protocol and topline statements, not a consumer protocol.
Is this a published paper?
No. It is a 7 September 2026 company announcement. Detailed results are planned for ObesityWeek 2026.
This article is for general informational purposes only and is not medical advice. Talk to a licensed clinician about personal medical decisions. Semaglutide products have specific labeled uses. Nothing here is a dosing protocol, an availability claim, or a recommendation to use an approved or unapproved product in a child.
Continue your research
- Semaglutide price comparison
- Semaglutide research profile
- What the GLP-1 pipeline showed at ADA 2026
- GLP-1s beyond weight loss
- Survodutide SYNCHRONIZE Phase 3
Sources
- Novo Nordisk. STEP Young phase 3 data: 40.4% of children living with obesity achieved a BMI below the obesity threshold with semaglutide and lifestyle modification. Ritzau / GlobeNewswire. 7 September 2026
- Novo Nordisk STEP Young press-release PDF attachment. GlobeNewswire. 7 September 2026
- ClinicalTrials.gov NCT05726227. STEP Young / NN9536-4512
- EU CTIS 2022-502922-41-00. STEP Young
- FDA. Wegovy (semaglutide) injection prescribing information. NDA 215256/S-024. Revised August 2025
- Novo Nordisk homepage teaser for the 7 September 2026 STEP Young headline