Key Highlights
- In the STEP Young clinical trial, 40.4% of children between 6 and 12 years old successfully reduced their BMI below obesity levels after 68 weeks of semaglutide treatment
- Not a single participant in the control group receiving placebo achieved similar BMI improvements
- The pharmaceutical company terminated two additional cardiovascular studies of ziltivekimab following recommendations from an independent monitoring board citing minimal chance of positive outcomes
- The drug candidate had previously failed to demonstrate efficacy in a pivotal late-stage cardiovascular study conducted in July
- Shares of NVO declined 1.92% during Monday’s trading session
Novo Nordisk presented contrasting updates on Monday, combining encouraging pediatric obesity trial outcomes with disappointing news regarding the termination of two additional cardiovascular drug studies.
The company’s stock traded down 1.92% to $46.60 as investors processed the implications of both announcements.
The phase 3 STEP Young clinical study evaluated weekly administration of semaglutide in 165 pediatric patients aged 6 to under 12 years who were classified as obese. Following 68 weeks of treatment, 40.4% of children receiving the active medication successfully reduced their BMI below the obesity classification threshold. By contrast, zero children in the control group achieved this milestone.
Every participant received comprehensive lifestyle intervention support, which encompassed guidance on calorie-restricted diets and recommendations for enhanced physical activity for the duration of the study.
The study successfully achieved its primary efficacy endpoint, demonstrating statistically significant BMI reduction in participants treated with semaglutide versus those receiving placebo. More than 85% of enrolled children presented with severe class II or III obesity at baseline.
Participants were administered either 1.7 mg or 2.4 mg doses of semaglutide on a weekly basis, with dosing determined by their initial body weight.
According to Ania M. Jastreboff, Professor of Medicine and Pediatrics at Yale University, the findings represent meaningful progress considering the advanced degree of obesity observed in the majority of study participants at enrollment.
The safety profile and tolerability observed in this pediatric population aligned with data from earlier studies conducted in adult and adolescent populations. Investigators identified no novel safety signals, and assessments revealed no adverse impacts on growth trajectories or pubertal maturation.
The company intends to unveil comprehensive study findings at ObesityWeek 2026, scheduled to take place in Washington DC from November 14 through 17.
Cardiovascular Drug Disappointment Weighs on Sentiment
The encouraging pediatric trial data was counterbalanced by the announcement that Novo discontinued two supplementary clinical trials evaluating its investigational cardiovascular therapy ziltivekimab.
Both studies were investigating the compound in heart failure populations and were terminated prematurely following a recommendation from an independent data monitoring committee, which determined there was minimal probability either trial would yield outcomes substantially different from a previous unsuccessful study.
During July, ziltivekimab had already demonstrated failure in reducing the incidence of major adverse cardiovascular eventsāencompassing death, non-fatal myocardial infarction, and non-fatal strokeācompared to placebo in a late-stage clinical trial.
These consecutive setbacks represent a significant obstacle to Novo’s strategic initiative to diversify its portfolio beyond its core obesity and diabetes franchise.
This disappointment compounds recent cardiovascular trial failures from Novartis, whose investigational compound was similarly predicated on the inflammatory disease hypothesis that formed the scientific foundation for both therapeutic candidates.
Looking Forward
A single remaining ziltivekimab clinical trial continues to enroll and follow patients, focusing on individuals recovering from acute myocardial infarction. Top-line data from this study is anticipated during the first half of 2027.
According to research published Friday, prescriptions for GLP-1 receptor agonist medications in U.S. children under 12 years of age have surged more than 300-fold since 2019, despite the absence of regulatory approval for semaglutide in this pediatric demographic.
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