Weight loss products for children? Study results

Children who took the weight-loss drug liraglutide in a late-stage trial lost significantly more weight than children who received a placebo, according to a new study.

Doctors say it can be extremely difficult for people with obesity to lose weight, regardless of age. Most adults and children as young as 12 have access to highly effective new drugs called GLP-1 receptor agonists. But younger children must rely solely on lifestyle changes such as diet, exercise and counseling to lose weight. Even with more aggressive measures, children generally see only modest results, doctors say.

The first study on the effects of the GLP-1 drug liraglutide, sold under the brand names Saxenda and Victoza, on younger children found that the drug can have a significant impact on their body mass index (BMI), the measure doctors use to determine whether a person is obese.

Liraglutide was approved by the U.S. Food and Drug Administration in 2014 to support weight loss in adults. In 2020, that approval was expanded to include children ages 12 to 17.

The study was published Tuesday in the New England Journal of Medicine and presented at the annual conference of the European Association for the Study of Diabetes by its lead co-author, Dr. Claudia Fox, a pediatrician affiliated with the Center for Pediatric Obesity Medicine at the University of Minnesota Medical School in Minneapolis.

The researchers examined the drug's effects on children between the ages of 6 and 12 who had a BMI considered high. The average 10-year-old in the study weighed about 70 kilograms, according to Fox.

The study involved 82 children, 56 of whom received a once-daily injection of liraglutide. The rest received a placebo. All children also received counseling to encourage them to eat a healthier diet and do at least one hour of moderate to vigorous physical activity daily.

The results of the two groups differed significantly. In just over a year, the BMI of the children who received the drug fell by 7.4 percentage points more than that of the children in the placebo group. The BMI of the children in the liraglutide group fell by 5.8 percent. The BMI of those in the placebo group rose by 1.6 percent.

The study was funded by the drug manufacturer Novo Nordisk.

The results were consistent with other studies conducted with teenagers, Fox said, but the results were better in younger children.

“That's what surprised me the most and makes me think that maybe we should intervene at a younger age,” Fox said.

The study does not directly compare weight loss between different age groups, so more research is needed to determine whether their theory holds true.

Liraglutide was considered safe for the young children in the study, but participants in both the placebo and drug groups experienced some side effects.

Stomach problems such as nausea, diarrhea and vomiting were more common in the group that received the drug, but Fox said very few people dropped out of the study because of the side effects. Stomach problems usually occurred early in the study and subsided over time, she said.

The study also wasn't designed to look at how long the children had to take the drugs. When the trial period was over and the children stopped taking the drugs or receiving counseling, their BMI started to rise again. However, the increase in this younger age group was not as significant as it was in teenagers in previous studies, and this may mean that the drugs have a more robust effect in the long term when taken earlier.

“We know that obesity is a chronic disease,” Fox said. “Once the intervention is over, the disease can return, and that's true of any other chronic disease, whether it's diabetes, asthma, hypertension – any chronic disease that requires chronic treatment.”

Any drug that could help obese children could have a major impact on the health of the population. Obesity is considered the most common chronic health problem among children in the United States. Almost 20 percent of all children have what is known as a high BMI. And the number continues to rise. According to the U.S. Centers for Disease Control and Prevention, the prevalence has more than tripled since the 1970s.

Obesity is not just a short-term problem. Overweight children tend to grow into adults who may struggle with associated health problems throughout their lives, Dr Simon Cork, senior lecturer in physiology at Anglia Ruskin University, told the Science Media Centre.

“The evidence that liraglutide is both safe and effective in children is positive,” said Cork, who was not involved in the research.

Developing anti-obesity drugs for children is complicated because children are still growing, he said. More studies following children over longer periods will be needed to make sure appetite suppression doesn't have later developmental consequences. There was no evidence in the new study that liraglutide had a detrimental effect on children's height or puberty, but scientists need to make sure the drugs don't stunt growth.

Early puberty can be a problem for overweight children, as can type 2 diabetes, and later they can develop heart problems, liver and kidney disease, and cancer. But a weight-loss drug that proves effective in the long term could do much more for health than just help with weight loss. Studies show that overweight children can also face significant prejudice and stigma.

“As there may be longer lasting health benefits from treating children and young people with obesity, their value in reducing the risk of obesity-related diseases and improving long-term health needs to be considered, even if these drugs are currently expensive,” Dr. Nerys Astbury, associate professor of nutrition and obesity in the Nuffield Department of Primary Health Care Sciences at the University of Oxford, told the Science Media Centre. Astbury was not involved in the new study.

In December, a draft guideline from the U.S. Preventive Services Task Force – which influences whether health insurers cover medical treatment – recommended that doctors provide intensive behavioral interventions to help children lose weight, but did not recommend weight-loss drugs or surgery.

The American Academy of Pediatrics, which updated its own guidelines for treating patients with obesity in 2023, recommends both options for some people.

Although doctors — and even parents — don't always agree, Fox believes weight-loss medications and surgical procedures such as gastric bypass or sleeve gastrectomy should be an option for children.

“There is a feeling among patients' families that all they need to do is try harder to lose weight, but going to the park more often and eating better is not always enough,” she said. “We cannot rely solely on behavioral interventions for a biological disease and achieve significant improvement.”