A late-stage clinical trial has found that Mounjaro (active ingredient: tirzepatide), a drug currently approved for adults, significantly improves blood sugar control and reduces body fat in children aged 10-17 years with type 2 diabetes. The findings, presented for the Study of Diabetes (EASD) meeting in Vienna, offer hope at a time when type 2 diabetes is rising sharply among young people.
Type 2 diabetes in children is no longer rare. According to health authorities, diagnosis rates among young people increased from around 9 per 100,000 in 2002 to about 18 per 100,000 in 2018. If current trends persist, estimates suggest the number of young Americans with the disease could rise from c. 28,000 in 2017 to over 220,000 by 2060.
Despite this rapidly increasing burden, treatment options for children are limited, usually restricted to metformin, basal insulin, or older GLP-1 drugs. There is a high unmet medical need for better therapies that both control glucose and reduce obesity, a major factor in disease progression.
In the trial, dubbed SURPASS-PEDS, 99 young people (aged 10-17) with type 2 diabetes whose blood sugar was insufficiently controlled using existing treatments were randomised to receive either 5 mg or 10 mg of tirzepatide once weekly, or a placebo, for 30 weeks, after which all continued on active treatment in a 22-week extension.
HbA1c (long-term blood sugar) reductions of around 2.2 % in those on tirzepatide, compared to very little change in the placebo group. Body Mass Index (BMI) dropped 7.4 % in the 5 mg group and 11.2 % in the 10 mg group by 30 weeks, compared to a drop of only about 0.4 % in the placebo group.
A high proportion of participants on tirzepatide achieved HbA1c levels considered below the diabetic or even pre-diabetic thresholds: 79 % of children got below 6.5 %, and 53 % had levels under 5.7 %. In contrast, far fewer in the placebo arm reached these benchmarks. These improvements were maintained through 52 weeks, with no evidence that effects had plateaued in the duration observed.
The safety profile in younger patients was broadly similar to what has been seen in adult trials. Most adverse events were gastrointestinal (nausea, diarrhoea, vomiting, abdominal pain), generally mild to moderate, and most pronounced early in treatment.
Discontinuations due to adverse effects were few. Importantly, there were no instances of severe hypoglycaemia in the study. Some mild low-blood-sugar events (below ~54 mg/dL) were more frequent among those on tirzepatide.
Although this trial was conducted, the implications are substantial. The National Health Service (NHS) already faces heavy strain from rising rates of obesity and diabetes, including among younger patients. More effective treatments that reduce both blood glucose and body weight could lessen long-term complications, reduce hospital admissions, and lower downstream health care costs.
Moreover, having a therapy that can safely achieve HbA1c reductions and BMI improvement might change guidelines and offer clinicians a more powerful option beyond metformin, insulin and existing GLP-1 drugs. For children who struggle with therapy adherence, weight gain, or poor control, tirzepatide could offer a more durable and effective alternative.
The trial included a relatively small sample (99 participants), and the demographic diversity, long-term safety beyond one year, and real-world effectiveness are still to be fully established. As with all medications, side effects must be weighed carefully, especially in a paediatric population with differing physiology, growth, and development.
Regulatory approval (MHRA), as well as guidance from NICE, would be needed before Mounjaro can be prescribed for children here. It’s not yet licensed for paediatric use. Costs, access, and monitoring will be important considerations, including ensuring equitable access across all regions.
The SURPASS-PEDS study provides compelling early evidence that Mounjaro could fill a significant gap in treatment for young people with type 2 diabetes. With substantial improvements in both HbA1c and BMI, sustained over a year, and an acceptable safety profile, it stands as one of the most promising developments in paediatric diabetes care in recent years.
If further follow-up confirms long-term safety and effectiveness, and regulators approve its use in children, Mounjaro may well become part of the standard toolkit in the fight against rising diabetes in young people. Until then, it remains an encouraging breakthrough, rather than a ready-to-use solution.
