Novo Nordisk's Wegovy Shows Promise in Young Children — But Investors Should Wait Before Celebrating

 Novo Nordisk's Wegovy Shows Promise in Young Children — But Investors Should Wait Before Celebrating

**A late-stage trial found that 40.4% of children aged 6 to under 12 treated with semaglutide were no longer classified as having obesity after 68 weeks, compared with none in the placebo group . The results expand the potential market for Novo's blockbuster weight-loss drug — but regulatory approval for this younger demographic is still years away.**

## The Numbers That Matter

The data from the STEP Young phase 3 trial is encouraging:

| Metric | Semaglutide Group | Placebo Group |

|--------|-------------------|---------------|

| **No longer classified as having obesity** | 40.4% | 0%  |

| **Trial duration** | 68 weeks | 68 weeks |

| **Lifestyle modification** | Both groups received reduced-calorie diet and increased physical activity | Same |

| **Severe obesity at baseline** | >85% had class II or III severe obesity  | Same |

"The results showed that 40.4%* of those treated with semaglutide were no longer classified as having obesity** at week 68, compared with none of those treated with placebo," Novo Nordisk said in its official announcement .

The trial, called STEP Young, enrolled 165 children aged 6 to under 12 with obesity . More than 85% of participants had severe class II or III obesity at baseline — corresponding to a BMI above or equal to 35 and 40 in adults, respectively .

## What the Experts Are Saying

"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," said Ania M. Jastreboff, MD, PhD, Professor of Medicine and Pediatrics at Yale and Director of the Yale Obesity Research Center .

"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," she added .

Martin Holst Lange, Novo's Chief Scientific Officer, framed the results as a broader health opportunity: "For children living with obesity and their families, health challenges can begin early and affect wellbeing throughout life. 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 Market Context: Off-Label Demand Is Already Surging

The trial comes at a time when prescriptions for GLP-1 weight-loss drugs among U.S. children under 12 have already skyrocketed — despite the drugs not being approved for that age group.

A study published in the journal *Pediatrics* on September 4 found that prescriptions for GLP-1 weight-loss drugs among children aged 8 to 11 with obesity rose from 0.03% in 2019 to **9.3% as of June 2026** — a more than 300‑fold increase .

The study, which included more than 3.5 million children, found that 94% of those prescribed GLP-1s had severe obesity, and about 65% had at least one related condition such as high cholesterol, high blood pressure, or sleep apnea .

Overall, 20,282 children received GLP-1 drugs during the study period — most often Novo Nordisk's Wegovy, though doctors also prescribed Novo's Saxenda and Eli Lilly's Zepbound .

**Children living in higher-income communities were 55% more likely to be prescribed the medicines**, suggesting emerging disparities in access .

"Physicians and health policymakers alike have a responsibility to ensure … these valuable and sometimes costly treatments become available to more than those who have access to health insurance and can afford to visit pediatric clinics," said Allan Massie, co-author of the study .

## What This Means for Investors

### The Bull Case

The STEP Young results are **clearly positive** for Novo Nordisk . They validate semaglutide's efficacy in a younger population and could open a significant new growth opportunity.

**Expanding the addressable market** is the key takeaway. If regulators ultimately approve Wegovy for children aged 6 to under 12, Novo could gain access to patients earlier in the obesity disease cycle, potentially creating a longer duration of treatment and a broader addressable market .

**Competitive positioning** is another factor. This is the first trial examining Wegovy's effect specifically in young children, and Eli Lilly has yet to demonstrate similar results in this age group .

### The Bear Case

**Regulatory approval is still years away.** The trial does not immediately translate into a new revenue stream. Novo will need to seek regulatory approval before Wegovy can be broadly marketed for children in this age group .

**Long-term safety data is still pending.** Treating young children for obesity raises particularly important questions around long-term safety, growth, development, and how long patients would need to remain on therapy . Novo's study is scheduled to evaluate additional outcomes through week 104 .

**The headline result assumes adherence to treatment.** The 40.4% figure represents the treatment effect if children remain on therapy, rather than necessarily reflecting what will happen across a real-world population where adherence, discontinuation, and access can be less consistent .

**Novo's reliance on obesity is becoming a concern.** The company faces pressure to sustain growth from its obesity franchise, and recent setbacks outside obesity highlight why investors remain focused on whether the company can build growth beyond its existing GLP-1 franchise .

## Frequently Asked Questions (FAQs)

### 1. What did the STEP Young trial find?

The trial found that 40.4% of children aged 6 to under 12 treated with semaglutide were no longer classified as having obesity after 68 weeks, compared with none in the placebo group . Both groups received lifestyle modification, including a reduced-calorie diet and increased physical activity .

### 2. How many children were in the trial?

The trial enrolled 165 children aged 6 to under 12 with obesity . More than 85% had severe class II or III obesity at baseline .

### 3. What is semaglutide?

Semaglutide is the active ingredient in Novo Nordisk's blockbuster weight-loss drug Wegovy. It is a GLP-1 receptor agonist that helps regulate appetite and food intake .

### 4. Is Wegovy already approved for children under 12?

**No.** Wegovy is not currently approved for children under 12 in the U.S. However, clinical guidelines allow the medications to be used for obesity in children as young as eight years old in certain cases .

### 5. Why are children already being prescribed Wegovy off-label?

Prescriptions for GLP-1 weight-loss drugs among U.S. children under 12 have risen more than 300-fold since 2019, despite the drugs not being approved for that age group . Doctors are seeking new, effective treatments for younger patients with severe obesity .

### 6. What were the side effects?

The overall safety and tolerability of semaglutide observed in STEP Young were consistent with previous Novo Nordisk pediatric and adult trials, and no new safety concerns were identified. No safety concerns were identified for growth or pubertal development .

### 7. When will the full results be presented?

Detailed STEP Young results will be presented at The Obesity Society's annual meeting, ObesityWeek 2026, from November 14-17 in Washington DC .

## The Bottom Line

The STEP Young results are clearly positive for Novo Nordisk, but they are more of a **long-term growth catalyst** than an immediate earnings driver . Showing that semaglutide helped 40.4% of severely obese children move below the obesity threshold gives Novo a strong clinical foundation for potentially expanding Wegovy into the 6‑to‑under‑12 population.

However, the investment case still depends on regulatory approval, longer-term pediatric safety data, and sustained treatment adherence . At the same time, Novo's recent setbacks outside obesity highlight why investors remain focused on whether the company can build growth beyond its existing GLP-1 franchise.

Overall, the news tilts bullish for Novo Nordisk: it reinforces the durability and breadth of the Wegovy franchise, but the commercial impact is likely to materialize gradually rather than immediately .

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## Disclaimer

*This article is for informational and educational purposes only and does not constitute financial, investment, tax, or legal advice. All views expressed are based on publicly available information as of September 7, 2026. Clinical trial results, regulatory approvals, and market conditions are subject to change. Past performance is not indicative of future results. Before making any financial or investment decisions based on the content of this article, please consult with qualified professionals who can evaluate your specific situation.*