Semaglutide: Safety and Efficacy in Children Aged 6-12 for Weight Loss – University Hospitals Trial with Novo Nordisk

Is semaglutide, the active substance in the popular ‘weight loss injection’ Ozempic, also effective and safe for children between 6 and 12 years old? The university hospitals of Antwerp, Leuven and Brussels will help answer this question in the coming years. They started a trial together with producer Novo Nordisk, De Tijd reported this weekend.

The results of a study in adolescents, published in The New England Journal of Medicine, suggest the best. The impact on obese adolescents was greater than on adults. After 68 weeks, the BMI of the participants fell by an average of 16 percent.

1 Which children participate in the new study?

This concerns a select group, says Dr. Karolien Van De Maele, pediatric endocrinologist and coordinator of the obesity team at the UZA. The children are at the absolute top of the weight curve – think of a BMI above 35. ‘Moreover, they have been followed for a long period of time by a multidisciplinary team of doctors and dieticians. We often see physical consequences of obesity in these young children: diabetes, liver damage or high blood pressure.’

2 What is the goal and what are the possibilities?

The potential is enormous, Van De Maele emphasizes. ‘We know that two-thirds of children who are obese remain obese as adults. If we can eliminate that at a young age, the long-term benefit will be very significant.’ This is not about ‘being thin’, she emphasizes. ‘We want young people to start adult life as healthily as possible.’ This means that they have a lower risk of cardiovascular disease or diabetes, but also a better self-image.

3 What are the risks?

“The impression should not be given that Ozempic is a panacea,” says Van De Maele. ‘This is an addition, not a replacement. First of all, you have to adjust your lifestyle, eating habits and exercise pattern.’ She is already seeing the consequences of that assumption today. ‘People say at the first consultation: “I want that injection”. It doesn’t work that way. And it shouldn’t happen like that to children.’

As far as risks are concerned, many questions remain. ‘We know it is effective and safe. But that’s where it ends.’ With vomiting and nausea, side effects in adolescents appear relatively mild. Long-term effects are still a matter of speculation.

One of the crucial questions becomes what happens when the patient stops the injections. ‘In adults we saw that the weight was regained easily. The expectation is that the gains will be greater among children, partly because they adopt healthy habits more easily.’ In any case, we have to wait. ‘It will take another 5 years before we have a good view.’ The outcome of these and other studies may change the direction of the discussion: ‘What if it turns out that you have to take it for life? Who do you prescribe it to and do we pay it back?’

4 What about affordability and availability?

General practitioners are already allowed to prescribe Ozempic, but only diabetes patients receive reimbursement from the health insurance company. For other users, the cost per month is about 100 euros. There is currently no form of reimbursement for under-18 year olds. “We urgently need to think about the extent to which we will regulate semaglutide,” says Van De Maele. ‘Do we leave the market free or do we move towards more control? I am a big proponent of only using semaglutide for specialist use, especially in children and young people. Just like with growth hormones or medication for type 1 diabetes in young people, you can create a clear framework in this way.’

2023-09-24 20:10:41
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