Childhood Obesity Treatment Gap

Childhood obesity continues to rise at an alarming rate in the United States, mirroring trends seen in adults but with even more concerning long-term implications. Today, more than 150 million Americans are living with obesity, including roughly 15 million children. While most people recognize that obesity is linked to serious conditions such as Type 2 diabetes, heart disease, and sleep apnea, fewer realize that these illnesses are increasingly affecting younger populations.
One of the most troubling aspects of obesity is that its impact compounds over time. The longer the body carries excess weight, the greater the cumulative stress placed on organs, metabolism, and overall health. When obesity begins in childhood, that timeline of exposure becomes significantly longer — often leading to more severe complications in adulthood.
Evan P. Nadler, M.D., the founder of ProCare Consultants and ProCare TeleHealth, penned an article for Clinical Leader, providing his take on why excluding children from clinical trials might present obstacles in the proper treatment of childhood obesity with weight loss drugs.
He wrote:
With most diseases, the longer you have it, the worse it gets. Obesity is no different. The damage is cumulative. It’s not just about how much you weigh — it’s about how long your body has been exposed to that weight. So one would think that the imperative to find solutions for childhood obesity would be front and center for those who are involved in clinical research involving the next generation of anti-obesity medicines. Unfortunately, that isn’t the case.
Despite this urgency, children remain largely underrepresented in the rapidly advancing field of anti-obesity drug development.
The landscape of obesity treatment has changed dramatically in recent years. Breakthrough medications have transformed how clinicians approach weight management, offering new hope for patients who previously had limited options.
Recent approvals from the U.S. Food and Drug Administration have brought injectable treatments such as semaglutide and tirzepatide into mainstream medical practice, with studies showing substantial weight loss outcomes. Researchers are also developing oral versions of these medications, along with next-generation therapies like orforglipron, maritide, and retatrutide.
Some of these emerging treatments target multiple metabolic pathways at once. In clinical trials, triple-receptor therapies have demonstrated weight-loss results comparable to bariatric surgery — an outcome that was nearly unimaginable just a decade ago.
However, most of these advancements are focused on adult populations. Currently, only a limited number of GLP-1–based medications are approved for adolescents ages 12 and older. Even then, options remain restricted, and some require daily injections, which can be difficult for younger patients to maintain. Meanwhile, several promising drugs remain years away from pediatric approval.
Why children are often left out of clinical trials
A major reason for the treatment gap lies in how clinical trials are structured. Pharmaceutical companies typically complete adult trials first before expanding research into pediatric populations. While safety considerations play a role, regulatory frameworks also contribute to delays.
In the United States, pediatric studies are encouraged but not always required early in the drug development process. Companies may postpone these trials until adult approvals are secured, which often results in multi-year delays before children gain access to new therapies.
This delay can create arbitrary access gaps. For example, a medication approved for an 18-year-old may not be available for a 17-year-old — even though the medical condition is essentially identical.
Because adult markets are larger and more profitable, pediatric studies are often deprioritized. Unfortunately, this approach overlooks the long-term health benefits of early intervention.
How Europe takes a different approach
Regulatory policies differ internationally. Within the European Union, pharmaceutical companies must submit a Pediatric Investigation Plan before completing adult trials for new medications. While the pediatric studies themselves may still occur later, the requirement ensures that children are part of the development strategy from the beginning. This structured planning process has resulted in more consistent pediatric drug research compared to the U.S., where early inclusion is often optional.
Despite groundbreaking progress in obesity pharmacotherapy, many of the newest medications still lack clear pediatric development timelines. Public regulatory databases show limited planning for children in several ongoing drug pipelines, reinforcing concerns that young patients may wait years before benefiting from new therapies.
The contrast is striking. Innovation is accelerating, yet access remains uneven.
The growing childhood obesity crisis highlights the need for a shift in how treatments are developed and approved. Early intervention — whether through lifestyle programs, behavioral care, or medical therapy — can dramatically change long-term health outcomes.
As new anti-obesity medications continue to reshape treatment possibilities, experts increasingly call for regulatory reforms that prioritize pediatric inclusion from the start. Without that change, millions of children may remain on the sidelines of one of the most significant medical advancements in metabolic health.
Dr. Nadler wrote:
So what does this all mean for children with obesity in the U.S.? Despite all the GLP-1- development, children are not part of the gameplan… The time has come for the FDA to rethink how it approaches clinical trials in children for the sake of the 15 million children with obesity…
Your responses and feedback are welcome!
Source: “The Problem With Excluding Children From GLP-1 Trials In The U.S.,” Clinical Leader, 2/19/26
Source: “Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction,” FDA, January 2025
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