Some experts favor lifestyle changes over medications to treat obesity in young children
Novo Nordisk’s Saxenda is already approved for children 12 and older who have a high body mass index.
Amid an ongoing debate over what role, if any, GLP-1 medications should play in treating children who struggle with excess weight while still in elementary school, researchers have concluded that a Novo Nordisk obesity drug may be safe and effective for kids as young as 6 years of age.
Liraglutide, a GLP-1 medication marketed by Novo Nordisk as the weight-loss drug Saxenda and the diabetes treatment Victoza, produced an average reduction in body mass index of 5.8% among 6- to 11-year-olds who took the drug for just over a year as part of a late-stage clinical trial, researchers found. That compares with an average BMI increase of 1.6% for trial participants taking a placebo, according to the study, which will be presented at the annual meeting of the European Association for the Study of Diabetes in Madrid this week and published in the New England Journal of Medicine.
Nearly half of the trial participants taking liraglutide achieved a BMI reduction of at least 5%, compared with about 9% of those taking placebo. As expected among growing children, both study groups gained some weight during the trial period. The children taking liraglutide gained an average 1.6% of body weight, while those taking placebo gained 10%.
The results “offer considerable promise to children living with obesity,” Claudia Fox, lead author of the study and co-director of the University of Minnesota Medical School’s Center for Pediatric Obesity Medicine, said in a statement. “To date, children have had virtually no options for treating obesity. They have been told to ‘try harder’ with diet and exercise.”
The prevalence of obesity among U.S. kids age 6 through 11 has grown over the past couple of decades, from 15.8% around the turn of the millennium to nearly 20%. The condition often persists into adulthood and is linked with serious complications, including Type 2 diabetes and some types of cancer.
But even as adults and their healthcare providers have quickly embraced newer obesity medications, there’s not yet a clear consensus on what role the drugs should play in treating younger children. The U.S. Preventive Services Task Force in June recommended that kids age 6 and older with a high BMI receive intensive, comprehensive behavioral interventions, such as education about healthy eating habits, counseling on goal-setting and problem-solving, and supervised exercise. As for weight-loss medications, the task force said that more research is needed to fully understand the long-term health outcomes, including possible harms. The task force is an independent panel of medical experts supported by the federal Agency for Healthcare Research and Quality.
The American Academy of Pediatrics, meanwhile, last year issued guidelines saying that there wasn’t enough evidence to recommend use of medications solely for obesity in kids younger than 12. Saxenda is currently approved by the Food and Drug Administration for children 12 and older who have a high BMI.
So far, no medications have been approved for the treatment of general obesity in kids younger than 12. And for some children, lifestyle changes such as adjustments in diet and physical activity may make a meaningful difference, Fox said at a press briefing Tuesday. “We have to be cautious and not imply that these medications are appropriate for every child,” Fox said. But children with more severe forms of obesity, she added, “are not seeing adequate results with lifestyle therapy alone.”
All of the participants in the new trial, which was funded by Novo Nordisk, also received counseling that encouraged sticking to a healthy diet and getting regular exercise. The study also found that kids taking liraglutide had more improvement in diastolic blood pressure and blood-sugar levels.
More than 12% of the children taking liraglutide, however, had serious side effects, compared with 7.7% of those on placebo. As has been seen with adults taking GLP-1 drugs, most of those negative effects were gastrointestinal. Among the children taking liraglutide, 11% stopped the treatment due to side effects, compared with none in the placebo group.
The study involved 82 children, and “with such a small sample, it’s hard to know, are there more rare side effects that could have emerged or will emerge” once more patients are exposed to the drug, Fox said to reporters Tuesday. “We need much longer-term data and much bigger numbers.”
As with adult patients, there are also concerns about what might happen after children stop taking the medications. Increases in BMI among trial participants after liraglutide treatment stopped are “worrisome,” researchers from the U.K.’s University of Birmingham and University of Bristol wrote in an editorial also published in the New England Journal of Medicine, because such increases imply an ongoing need for medications to prevent a rebound in BMI.
Kids participating in the trial have the option to restart the medication for another 56 weeks, followed by two years of observation after treatment stops, which will help gather longer-term data on the drug’s safety and efficacy, Fox said.
Novo Nordisk’s American depositary receipts have climbed 25% in the year to date, while the S&P 500 has gained 15%.