STEP Young phase 3 trial - sema for kids

x3737

Explorer
Joined
Apr 9, 2026
Messages
41
Reaction score
18
Location
europe
a5a8b5c3556bd3770d78b9c0c4b0f6e9b6141b381b5a28c44637ff7d9c95df65.png




Novo Nordisk STEP Young phase 3 data: 40.4% of children living with obesity achieved a BMI below the obesity threshold with semaglutide and lifestyle modification





dcdb241c6c9d09125d4f842648049117e7c1c6f045b04865024c0e0ea81e9dc9.png



www.biospace.com

I found these result interesting and figured i'd share them šŸ™‚

Data highlights

  • The STEP Young phase 3 trial met its primary endpoint, demonstrating greater body mass index (BMI) reduction in children aged 6 to under 12 treated with once-weekly subcutaneous semaglutide compared with placebo
  • Both groups received lifestyle modification throughout the trial, including reduced-calorie diet and increased physical activity
  • 40.4%* of the children treated with semaglutide were no longer classified as having obesity** after 68 weeks compared with non (0%) treated with placebo
  • The overall safety and tolerability of semaglutide were consistent with those seen in adults and adolescents trials with semaglutide

Click to expand...
 
Interesting article.

I have real mixed feelings on this though.

I’m generally an advocate of GLP1's and think they can do a lot of good for people, not just in terms of weight loss but overall health benefits and in terms of quality of life too.

That being said, reading about them being trialled in children as young as 6 does make me extremely uncomfortable.

I know these aren’t just kids carrying abit of extra weight, and I understand some will suffer from severe obesity and genuine health risks. I also appreciate lifestyle support is part of the treatment, so it’s not simply a case of giving a child medication and ignoring everything else.

I think it’s purely the age that I struggle with. 6 years old is so young and at that stage kids minds and bodies are still in early development and they are still early stages in terms of forming relationship with food, exercise and their own body.

My instinct would be focusing as much as possible on dieting, being active, family habits and the wider environment firstly. But I also know obesity isn’t always as simple as ā€œeat better and move moreā€, so there will probably be cases where medication does have its place.

I suppose the bit I’m most unsure about is the long term side of it all. If a child starts at 6 or 7, how long do they stay on it? What happens through puberty and into adulthood? And what happens if they stop?

The part I am most interested in is what happens after their treatment. What does several years of GLP1 use look like through childhood and puberty? What happens to growth, lean mass, eating behaviour and psychological development? Its hard to imagine, and frankly frightening.

I’m not completely against it, I just think I’d want to see a lot more long-term evidence before feeling comfortable with it becoming common in very young children.

I have a child under 6 and thankfully they do not have any weight related issues. But if they did, I could not allow them as their guardian, to undertake this type of treatment. The thought alone chills me to my core.
 
boytres said:


I have real mixed feelings on this though.

Click to expand...

I understand why you feel torn. I do not have children, but I can appreciate why potentially administering semaglutide to a six-year-old feels extreme.

But these were not children carrying a little extra weight. More than 85% had class II or III severe obesity, a serious chronic disease with potentially lifelong consequences. Withholding treatment is not a risk-free choice either.

I think some discomfort comes back to how we frame obesity. If we accept it as a chronic medical condition rather than a failure of habits or willpower, medication becomes easier to understand. Lifestyle intervention should absolutely be part of treatment, as it was here, but it is often insufficient. Would we react the same way to long-term medication for diabetes or another chronic disease?

Your questions about growth, puberty, lean mass, eating behavior, and psychological development are valid. Novo reported no safety concerns involving growth or pubertal development during the trial, but 68 weeks cannot answer questions about decades of treatment. Honestly, we do not yet know what decades of semaglutide use will look like even in adults.

There may also be no clear ā€œafter treatment.ā€ Many of these children may require long-term or lifelong therapy. The real comparison is not semaglutide versus a risk-free childhood. It is the uncertain long-term risks of treatment versus the known risks of untreated severe obesity.

Speaking personally, I came out of the womb obese. I suspect my parents would have jumped at the chance if a safe and effective medication for childhood obesity had been available. At six, I am not sure. By ten, probably. It is hard to say, but my parents are medical junkies.
 
Yeah, it's certainly suboptimal, but we know that kids like 6 years old are getting type 2 diabetes. We need to address this issue and we need to do so by aggressive means.
 
boytres said:


My instinct would be focusing as much as possible on dieting, being active, family habits and the wider environment firstly.

Click to expand...
I agree. And even this is fraught with danger.

The number of stories of moms taking teen and tween girls to weight watcher or putting them on a different diet. It marks a young person for a long long time. Yes so does class 2/3 obesity.

Such a fine line to walk with young people.
 
Grogu said:


I understand why you feel torn. I do not have children, but I can appreciate why potentially administering semaglutide to a six-year-old feels extreme.

But these were not children carrying a little extra weight. More than 85% had class II or III severe obesity, a serious chronic disease with potentially lifelong consequences. Withholding treatment is not a risk-free choice either.

I think some discomfort comes back to how we frame obesity. If we accept it as a chronic medical condition rather than a failure of habits or willpower, medication becomes easier to understand. Lifestyle intervention should absolutely be part of treatment, as it was here, but it is often insufficient. Would we react the same way to long-term medication for diabetes or another chronic disease?

Your questions about growth, puberty, lean mass, eating behavior, and psychological development are valid. Novo reported no safety concerns involving growth or pubertal development during the trial, but 68 weeks cannot answer questions about decades of treatment. Honestly, we do not yet know what decades of semaglutide use will look like even in adults.

There may also be no clear ā€œafter treatment.ā€ Many of these children may require long-term or lifelong therapy. The real comparison is not semaglutide versus a risk-free childhood. It is the uncertain long-term risks of treatment versus the known risks of untreated severe obesity.

Speaking personally, I came out of the womb obese. I suspect my parents would have jumped at the chance if a safe and effective medication for childhood obesity had been available. At six, I am not sure. By ten, probably. It is hard to say, but my parents are medical junkies.

Click to expand...

I can sympathise with you and everything you have said to be honest. I completely understand that this isn't just kids with a little extra weight they need to shed, this is genuine, life threatening and quality of life situations that need to be addressed.

I know my own opinion is not correct nor is any one persons and there probably isn’t a simple right or wrong answer here. If the evidence eventually shows that this does more good than harm for the majority of these children, then maybe it is the right way to go. I still personally feel uncertain and uncomfortable about it though.

That being said, i can respect the feelings and sentiments of everyone else in this. None of us know what prolonged use will bring for children, let alone for adults. I think this is where the maturity factor resonates with me. A 6 year old cannot make an informed conscious decision regarding their wellbeing long term and even short term would be questionable. I think that uncertainty is probably what feeds my fear and comfortability.
 
ladyj779 said:


Yeah, it's certainly suboptimal, but we know that kids like 6 years old are getting type 2 diabetes. We need to address this issue and we need to do so by aggressive means.

Click to expand...
I agree, it is horrible and we need to take action. I do not question that, i just wonder which action is the correct one.

It is a horrible subject to have to deal with for anyone facing it.

Foggy-Hollow said:


I agree. And even this is fraught with danger.

The number of stories of moms taking teen and tween girls to weight watcher or putting them on a different diet. It marks a young person for a long long time. Yes so does class 2/3 obesity.

Such a fine line to walk with young people.

Click to expand...
I think the stigma is probably one of the biggest problems here.

The global companies of today spend years bombarding kids and families with advertising for fast food, ultra-processed convenience food, sugary drinks and everything else that contributes to poor health then we as a society act shocked when childhood obesity becomes a major public health problem. And after that, the burden seems to fall almost entirely on the individual child and their family to fix it.

That’s the part I struggle with. We can talk about education, personal responsibility and medication, and all of those things probably have a role, but the environment people are growing up in matters as well.

There’s something backwards about allowing huge companies to spend billions shaping food choices from such a young age, then treating the consequences further down the line without really addressing what helped create the problem in the first place.

I think that’s probably what I’m getting at here. Society is rather flawed in this area. Until there’s some wider responsibility taken by governments, food manufacturers, advertisers and the big brands influencing what people consume, I don’t think childhood obesity is ever going to disappear.

Programs like the Novo one in the article may end up being extremely valuable for the children who need them, but they’re still treating one part of a much bigger problem. And i will always be uncomfortable with this form of treatment despite knowing it is probably more valuable than not.
 
boytres said:


I can sympathise with you and everything you have said to be honest. I completely understand that this isn't just kids with a little extra weight they need to shed, this is genuine, life threatening and quality of life situations that need to be addressed.

I know my own opinion is not correct nor is any one persons and there probably isn’t a simple right or wrong answer here. If the evidence eventually shows that this does more good than harm for the majority of these children, then maybe it is the right way to go. I still personally feel uncertain and uncomfortable about it though.

That being said, i can respect the feelings and sentiments of everyone else in this. None of us know what prolonged use will bring for children, let alone for adults. I think this is where the maturity factor resonates with me. A 6 year old cannot make an informed conscious decision regarding their wellbeing long term and even short term would be questionable. I think that uncertainty is probably what feeds my fear and comfortability.

Click to expand...

100% agree with all of this. There is no simple universal right or wrong answer here, and I do not want you to think I took your concerns lightly. As much as my parents loved sending us to doctors growing up, I still have difficulty imagining they would have put me on a weight-loss medication at six. That is incredibly young, and depending on the severity, there may be several reasonable interventions to try before or alongside medication.

A decision to put a child of any age on obesity medication would require a great deal of context and careful consultation with medical professionals. The child’s age and maturity; the severity and trajectory of the obesity; related health risks; previous interventions; and family environment would all need to be considered. Parents routinely have to make medical decisions for children who cannot yet provide informed consent, but that only makes a careful, individualized risk-benefit analysis more important.
 
Grogu said:


100% agree with all of this. There is no simple universal right or wrong answer here, and I do not want you to think I took your concerns lightly. As much as my parents loved sending us to doctors growing up, I still have difficulty imagining they would have put me on a weight-loss medication at six. That is incredibly young, and depending on the severity, there may be several reasonable interventions to try before or alongside medication.

A decision to put a child of any age on obesity medication would require a great deal of context and careful consultation with medical professionals. The child’s age and maturity; the severity and trajectory of the obesity; related health risks; previous interventions; and family environment would all need to be considered. Parents routinely have to make medical decisions for children who cannot yet provide informed consent, but that only makes a careful, individualized risk-benefit analysis more important.

Click to expand...
Totally agree.

Its a horrible world we live in and one our children will inherit, that alone is a heartbreaking fact let alone the conditions which they shall receive it. I hope we haven't set them up for total failure.
 
I think these two datapoints make it clear willpower has little to do with it šŸ˜ž

  • Both groups received lifestyle modification throughout the trial, including reduced-calorie diet and increased physical activity
  • 40.4%* of the children treated with semaglutide were no longer classified as having obesity** after 68 weeks compared with non (0%) treated with placebo

Click to expand...
Imagine being a parent feeling like a failure and getting these results.

0 patiens with lifestyle modifications reached a normal bmi in 68 weeks.

It’s a decease.
 
I freak out and wanna put my dog on Tirz, to help with the last 2 lbs. We got 7lbs off of him, it took over a year. I feel bad for the old fella, I can't fathom having a child with these problems. but would probably be open to them trying it. I know how it's changed my life and others I care about.
 
I think it fairly safe to say that other methods of reducing obesity in these kids have already been tried at least to some extent and failed, or that the obesity generating environment generally or in that home in particular cannot be readily modified in a way that actually works and helps the kids to be less fat. And I think it is worth being realistic, not all kids or parents are going to be all that good at implementing diet and exercise changes at home, just like most adults are not that great at long tern behaviour change, and if the obesity is severe they are probably better off being treated despite this. At this point given peoples' natural reluctance to use GLP medications in young kids would tend to make them not the very first option ever tried. I think with kids, as with adults managing it like a chronic metabolic problem is more likely to work, and the less guilt and shame and attempts at control , the better. How possible it is to fully control food intake in kids , as a method of managing obesity in them, in an environment with food surpluses , and mostly unhealthy food choices, is not straightforward, and is likely a lot harder than it was 30 or 40 years ago.

I had the experience of suddenly becoming fat at age 7, more than doubling my weight in 2 years for no obvious reason, and I was actually taken to a doctor to get help, but the only advice given was not to eat extra desserts, which not surprisingly did not have any effect. Given the fairly severe social harms obesity as a child caused me , I certainly would have preferred to be treated with GLP drugs. Perhaps bullying of obese kids is not quite as bad now as it was in the 70's and 80's when severe obesity was less common, but I doubt the problem has vanished.

Not that surprisingly my daughter also became obese in primary school, at a somewhat similar age. I had limited control over her diet, as she was not living with me most of the time, but she experienced significant social adversity from obesity as well, to the point where she chose to lose the weight at about age 12, entirely through her own efforts, and has kept it off ever since. She is pretty single minded when needed though, and I do not think this is at all a common occurrence, to fix obesity solely through diet and exercise at that age, and probably even less likely if the impetus is from outside like parents rather than the person themselves. But I would have no issues with her using GLP drugs now ( 18yo ) if her obesity returned or then at age 10 or so when it became a significant issue, obviously 8 or so years ago GLP drugs were not really available.

The ethics of grey or black market GLP use in kids is a minefield. Obviously a majority of parents of obese kids are not going to have the money to afford prescribed GLP drugs. Using grey GLP drugs instead would carry risks , if significant medical harm was caused to the child because of them, it would almost certainly be a child protection issue, and the parents would be considered responsible for causing that harm. I am not really sure what I would do if I was in the situation from 6 or 8 years ago, with a daughter distressed about her obesity. I would have had no reason to believe she would be one of the rare cases where people lose a lot of weight and keep it off long term. And the cost of GLP drugs would definitely have been a problem.
 
lessthanhalf said:


The ethics of grey or black market GLP use in kids is a minefield. Obviously a majority of parents of obese kids are not going to have the money to afford prescribed GLP drugs. Using grey GLP drugs instead would carry risks , if significant medical harm was caused to the child because of them, it would almost certainly be a child protection issue, and the parents would be considered responsible for causing that harm.

Click to expand...
Although your opinion differs from mine, I can actually agree with pretty much everything you've said here. I still respect your view and think it's completely valid, even if it doesn't fully line up with my own. That's one of the things I really like about this forum, people can disagree on something and still have a sensible discussion about it.

The part I quoted is probably the bit that worries me most.

I do worry about the amount of harm that could potentially come from parents using grey market GLP1's to treat children, especially if they simply can't afford the prescribed route.

For my own recon I am probably obsessive when it comes to sterility. I take far more care than most people probably would, but I also know not everyone is going to approach it in the same way. There are plenty of opportunities during recon for something to go wrong, contamination, poor handling, incorrect preparation etc, and in the worst case that could obviously cause serious harm.

When I'm doing that for myself, that's on me. If I make a mistake and something happens to me then I've accepted that risk and I'm responsible for it.

When you're talking about a child though, I think that changes things completely.

If a child was seriously harmed because of contamination, a mistake during recon, or simply because the parent didn't really know what they were doing, I would find that incredibly difficult to accept. I honestly don't think I could live with myself if I was the one responsible for that.

This is probably where my opinion shifts. I would actually support GLP1 treatment for children who genuinely need it being state funded in the US, NHS funded in the UK, and similarly funded elsewhere. I'd happily contribute towards that through taxation if it meant children who genuinely needed treatment could get it safely, through proper medical supervision, rather than parents feeling pushed towards grey market alternatives because they can't afford anything else.

It feels a bit strange even writing that because I've wrote before that I'm really uncomfortable with the idea of GLP1 use in children, especially when we're talking about kids as young as 6.

That hasn't really changed. I still feel very uneasy about what the long term effects could be when these drugs are started at such a young age.

But at the same time I can also accept that there are children where severe obesity is already having a major impact on their health and quality of life, and doing nothing isn't harmless either.

So I suppose my position is still one of caution. I'm not all of a sudde n comfortable with GLP1's being used in children, because I'm not. But I can also accept that for some children, with proper medical oversight, they could make a huge difference not only to the child but to their family as well.

I don't think those two views necessarily have to contradict each other.
 
boytres said:


The part I quoted is probably the bit that worries me most.

I do worry about the amount of harm that could potentially come from parents using grey market GLP1's to treat children, especially if they simply can't afford the prescribed route.

Click to expand...

Yeah, I didn't even conceptualize that parents might extrapolate the results of this study and think it's okay for them to put their child on grey market peptides. That would be really bad. One study doesn't make a do-it-yourself medical protocol, especially for a minor.

And it's bigger than just the use of grey market peptides, because I think if sourced correctly and tested that that risk is low. To me the issue is putting a child on a medically unsupervised treatment plan, having no prior workup before starting treatment, providing no ongoing support, and failing to provide proper age-appropriate behavioral therapy.

Trust me, all my medical providers know that I'm on tirzepatide. It's in my medical records. Not sure who or where they think I'm getting the medication. Don't ask don't tell 🤣.
 
Thinking of a specific kid I know of locally, what about the harm from a 6 year old girl being 20-30lb beyond a z score of +2? The long term risk of grey market peptides doesn't matter if she doesn't have a "long term" horizon. Her height is "normal" and she's gotta be approaching 100lb.

Easily seems like there should have some variety of legal implications for the parents; endangerment, negligence, etc.
 
Back
Top