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Novo Nordisk's Semaglutide Meets Goal in Pediatric Obesity Study
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Key Takeaways
NVO's STEP Young study showed greater BMI reduction with semaglutide versus placebo at week 68.
40.4% of children on semaglutide were no longer classified as having obesity after week 68.
Semaglutide's safety profile was consistent with prior pediatric and adult studies, with no new concerns.
Novo Nordisk (NVO - Free Report) announced positive data from the phase III STEP Young study evaluating once-weekly subcutaneous semaglutide, in combination with a reduced-calorie diet and increased physical activity, in children with obesity aged six to under 12 years.
More on the STEP Young Study Data
The phase III STEP Young study met its primary endpoint by demonstrating a greater reduction in body mass index (BMI) at week 68 following treatment with semaglutide versus placebo. Both treatment groups received lifestyle modification, including a reduced-calorie diet and increased physical activity.
Importantly, 40.4% of children who were treated with once-weekly subcutaneous semaglutide were no longer classified as having obesity after week 68, compared with none in the placebo group. More than 85% of children had class II or III severe obesity at baseline.
Per the company, two out of five children treated with semaglutide reduced their BMI below the obesity threshold, reaching either a normal-weight or overweight classification, compared with none of the children receiving placebo.
The overall safety and tolerability profile of semaglutide seen in the STEP Young study was consistent with prior pediatric and adult studies, with no new safety concerns reported.
The company plans to present detailed data from the phase III STEP Young study at the Obesity Society’s annual meeting in November.
NVO’s Price Performance
Year to date, shares of Novo Nordisk have declined 5.3% against the industry’s rise of 16.4%.
Image Source: Zacks Investment Research
NVO Thrives on Semaglutide-Based Medicines
Novo Nordisk markets its semaglutide-based medicines under the brand names Ozempic (injection and oral pill) and Rybelsus (oral tablet) for type II diabetes (T2D), and Wegovy (injection and oral pill) for chronic weight management.
The company’s semaglutide-based medicines continue to demonstrate benefits beyond blood sugar control and weight loss, including reducing cardiovascular (CV) risk and improving kidney disease outcomes.
Novo Nordisk has been witnessing strong success with its GLP-1 medicines, Wegovy for obesity and Ozempic and Rybelsus for T2D.
In the first half of 2026, total reported Obesity care sales increased 20% year over year in DKK, or 24% at constant exchange rates, driven by higher sales across the Wegovy portfolio, including incremental sales from the newly launched Wegovy pill.
In late December, the FDA approved NVO’s 25 mg oral semaglutide (Wegovy pill) for obesity and CV disease, which was subsequently launched in early January. The Wegovy pill is also approved in the EU.
NVO Faces Rising Competitive Pressure
Novo Nordisk faces intense competition from Eli Lilly (LLY - Free Report) in the obesity market. Lilly's Mounjaro for T2D and Zepbound for obesity have earlier demonstrated superior weight-loss efficacy in clinical studies, allowing the company to gain market share steadily. Despite being on the market for a shorter duration, these drugs have become LLY’s key top-line drivers.
Lilly has also secured FDA approval for its oral GLP-1 drug, orforglipron, for adults with obesity or overweight with weight-related medical problems, marketed under the brand name Foundayo.
While Novo Nordisk and Eli Lilly currently dominate this space, smaller biotechs like Structure Therapeutics (GPCR - Free Report) and Viking Therapeutics (VKTX - Free Report) are also advancing GLP-1–based therapies for treating obesity.
Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist (RA), VK2735, is being developed in both oral and subcutaneous formulations for the treatment of obesity. VKTX plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026.
Structure Therapeutics’ phase II ACCESS program on its orally administered small molecule GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Based on such encouraging results, GPCR has initiated dosing patients in its late-stage ACCOMPLISH program to evaluate aleniglipron for chronic weight management.
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Novo Nordisk's Semaglutide Meets Goal in Pediatric Obesity Study
Key Takeaways
Novo Nordisk (NVO - Free Report) announced positive data from the phase III STEP Young study evaluating once-weekly subcutaneous semaglutide, in combination with a reduced-calorie diet and increased physical activity, in children with obesity aged six to under 12 years.
More on the STEP Young Study Data
The phase III STEP Young study met its primary endpoint by demonstrating a greater reduction in body mass index (BMI) at week 68 following treatment with semaglutide versus placebo. Both treatment groups received lifestyle modification, including a reduced-calorie diet and increased physical activity.
Importantly, 40.4% of children who were treated with once-weekly subcutaneous semaglutide were no longer classified as having obesity after week 68, compared with none in the placebo group. More than 85% of children had class II or III severe obesity at baseline.
Per the company, two out of five children treated with semaglutide reduced their BMI below the obesity threshold, reaching either a normal-weight or overweight classification, compared with none of the children receiving placebo.
The overall safety and tolerability profile of semaglutide seen in the STEP Young study was consistent with prior pediatric and adult studies, with no new safety concerns reported.
The company plans to present detailed data from the phase III STEP Young study at the Obesity Society’s annual meeting in November.
NVO’s Price Performance
Year to date, shares of Novo Nordisk have declined 5.3% against the industry’s rise of 16.4%.
Image Source: Zacks Investment Research
NVO Thrives on Semaglutide-Based Medicines
Novo Nordisk markets its semaglutide-based medicines under the brand names Ozempic (injection and oral pill) and Rybelsus (oral tablet) for type II diabetes (T2D), and Wegovy (injection and oral pill) for chronic weight management.
The company’s semaglutide-based medicines continue to demonstrate benefits beyond blood sugar control and weight loss, including reducing cardiovascular (CV) risk and improving kidney disease outcomes.
Novo Nordisk has been witnessing strong success with its GLP-1 medicines, Wegovy for obesity and Ozempic and Rybelsus for T2D.
In the first half of 2026, total reported Obesity care sales increased 20% year over year in DKK, or 24% at constant exchange rates, driven by higher sales across the Wegovy portfolio, including incremental sales from the newly launched Wegovy pill.
In late December, the FDA approved NVO’s 25 mg oral semaglutide (Wegovy pill) for obesity and CV disease, which was subsequently launched in early January. The Wegovy pill is also approved in the EU.
NVO Faces Rising Competitive Pressure
Novo Nordisk faces intense competition from Eli Lilly (LLY - Free Report) in the obesity market. Lilly's Mounjaro for T2D and Zepbound for obesity have earlier demonstrated superior weight-loss efficacy in clinical studies, allowing the company to gain market share steadily. Despite being on the market for a shorter duration, these drugs have become LLY’s key top-line drivers.
Lilly has also secured FDA approval for its oral GLP-1 drug, orforglipron, for adults with obesity or overweight with weight-related medical problems, marketed under the brand name Foundayo.
While Novo Nordisk and Eli Lilly currently dominate this space, smaller biotechs like Structure Therapeutics (GPCR - Free Report) and Viking Therapeutics (VKTX - Free Report) are also advancing GLP-1–based therapies for treating obesity.
Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist (RA), VK2735, is being developed in both oral and subcutaneous formulations for the treatment of obesity. VKTX plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026.
Structure Therapeutics’ phase II ACCESS program on its orally administered small molecule GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Based on such encouraging results, GPCR has initiated dosing patients in its late-stage ACCOMPLISH program to evaluate aleniglipron for chronic weight management.
NVO Zacks Rank
Novo Nordisk currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.