In a late-stage clinical trial, a drug similar to Ozempic was shown to reduce body mass index in kids ages 6 to 11 with obesity, according to results published Tuesday in the New England Journal of Medicine.
The findings bring the phenomenon — and the controversy — of the latest new and powerful weight loss drugs to the youngest age group yet. With the exception of drugs for rare genetic disorders that cause obesity, there are no pharmaceutical options for obesity in children under 12.
The new trial looked at liraglutide, the active ingredient used in two of Novo Nordisk’s older GLP-1 drugs: Saxenda, a weight loss drug, and Victoza, a diabetes drug. Semaglutide, another GLP-1 also from Novo Nordisk, is the drug in Ozempic and Wegovy.
All are intended for lifelong use.
Given that 6 to 11 are crucial ages for a child’s development, there are concerns about how the medications might impact their growth, said Dr. Roy Kim, a pediatric endocrinologist at Cleveland Clinic Children’s in Ohio.
“We do not know the long-term effectiveness and safety of these medicines in children,” Kim said. “While the medicine was well tolerated, there are concerns about this category of medicines and possible pancreas problems, thyroid cancer risk and bone health over the lifetime.”
A growing number of kids in the U.S. have obesity, including 1 in 5 kids ages 6 to 11, according to the Centers for Disease Control and Prevention.
How well the drug works
The trial included 82 children with an average BMI of 31 who either got a once-daily injection of liraglutide or a placebo for 56 weeks.
Every child and their parents in the study also met regularly with a lifestyle coach to discuss healthy eating and exercise before starting the injections, said lead study author Dr. Claudia Fox, an associate professor of pediatrics at the University of Minnesota. Fox serves as a principal investigator for clinical trials sponsored by both Novo Nordisk and Eli Lilly.
Once the kids began taking the medication, they met less often with the coaches — about once every one to two months, Fox said.
Figuring out how well the drug worked wasn’t as simple as measuring weight loss because the kids are still growing, and each child grows at different rates, Fox said. So instead of looking at overall weight loss like in adult studies, they decided to focus more on BMI, which takes into account both weight and height.
“A five-pound change for a 6-year-old is very different from a five-pound change for a 10-year-old,” she said.
After 56 weeks, kids who got liraglutide saw an average BMI reduction of 5.8%, while the kids who got a placebo saw a 1.6% increase. Nearly half of the kids on liraglutide saw their BMI go down by at least 5%, compared to just 9% in the placebo group.
“To me, this sort of suggests that perhaps it is better to intervene earlier rather than wait until a kid is an adolescent,” Fox said.
The medication was well tolerated — similar to the findings in the adult trials — although gastrointestinal side effects were more common in the kids who got liraglutide, she said. The most common side effect was vomiting, followed by nausea and diarrhea. Older kids, she added, were able to give themselves the injections, while younger kids needed their parents to do it.
A spokesperson for Novo Nordisk said that it has submitted an application to the Food and Drug Administration to expand the approval of liraglutide for weight loss in children ages 6 to 11.
Is 6 too young for a weight loss drug?
As childhood obesity rates rise, some doctors have advocated for more aggressive approaches and earlier treatments.
In 2023, the American Academy of Pediatrics released new guidelines for treating childhood obesity, recommending for the first time weight loss drugs and, in some cases, surgery for children ages 12 and up. For kids under 12, the guidelines endorsed working closely with pediatricians and other health care providers to focus on lifestyle changes.
Dr. Sarah Armstrong, a professor of pediatrics at Duke University and a co-author of the American Academy of Pediatrics guidelines, said that medication will probably be necessary for children with severe obesity; that is, a BMI of at least 35.
“It is pretty clear that without effective treatment, this does tend to get worse, not better, over time,” Armstrong said. “If a child has severe obesity and maybe has developed some early life comorbidities, it’s probably the right thing to do.”
Still, she has some concerns about use of medications in young kids because of the long-term nature of treatment.
“What happens to kids if you put them on medication that makes them less hungry while they’re still growing?” Armstrong said. “Are they going to have delayed puberty? Are they going to have delayed growth? Will it somehow affect their bone density? Will it create disordered eating patterns that are going to cause other problems later in life?”
Kim, of Cleveland Clinic Children’s, said the weight loss in the trial was “relatively small” but promising. He also noted shortcomings of the trial, including that the study group and duration was small, with only 82 children taking the drug or a placebo for 56 weeks.
He also noted that the ethnic and racial makeup of the children in the trial “does not reflect the populations most seriously impacted by the obesity epidemic.” More than two-thirds of the kids in the trial were white.
Despite the shortcomings, “it is exciting because it is a taste of what’s to come,” Kim said. “We know there are more potent medicines, given once a week, that are on the market and approved for adults and adolescents.”
Wegovy, approved for people ages 12 and up, is a weekly injection, as is Zepbound, from Eli Lilly. Zepbound is only approved for adults.
Dr. Shauna Levy, a specialist in obesity medicine and the medical director of the Tulane Bariatric Center in New Orleans, said that while diet and exercise must continue to be mainstays for treating children with obesity, some kids would benefit from the drug.
“In my practice, I have seen 18 year olds with BMI of 60+ that are already suffering from their disease,” Levy wrote in an email. “We have long thought that weight is something that kids grow out of as they age; now that we understand obesity better we know that not only do not grow out of obesity, but it needs to be actively treated.”
