A drug approved to treat obesity in adults and adolescents is safe and effective for use in children as young as 6 years old when combined with diet and exercise, a small new study shows.
Liraglutide reduced body mass, slowed weight gain and improved health markers in children aged 6 to 11 yearsaccording to research presented at a medical conference and published in the New England Journal of Medicine.
Based on the trial results, drugmaker Novo Nordisk has asked U.S. regulators to expand the drug’s use to children in that age group, a company spokesman said. If approved, the drug would be the first authorized to treat the most common type of obesity affecting more than 20% of American children between the ages of 6 and 11, according to the U.S. Centers for Disease Control and Prevention.
“To date, children have had virtually no options for treating obesity,” said Dr. Claudia Fox, a pediatric obesity expert at the University of Minnesota who led the study. “They have been told to ‘try harder’ with diet and exercise”.
Side effects were common among those who received the drug, particularly gastrointestinal effects such as nausea, vomiting and diarrhea. And experts said doctors and parents would need to carefully consider those risks and the lack of data on long-term use of such drugs in young children.
“If a drug is approved for that age group, it would be a very useful tool, but we’ll also have to be careful about how broadly we start using it,” said Dr. Melissa Crocker, a pediatric obesity specialist at Boston Children’s Hospital who was not involved in the study. “And I would answer that question differently at age 6 than I would at age 11.”
Liraglutide belongs to a class of drugs called GLP-1s, which include blockbuster drugs Wegovy and Mounjaro. These drugs mimic hormones that affect appetite, satiety, and digestion. It is given as a daily injection and is approved under the brand name Victoza to treat diabetes in adults and children aged 10 years and older, and as Saxenda to treat obesity in adults and children aged 12 to 17 years.
The new study, funded by Novo Nordisk, included 82 children with an average age of 10 years and a starting weight of about 155 pounds. The average starting BMI was 31, above the obesity threshold childish.
More than half of the children had obesity-related health problems, such as insulin resistance, asthma or early puberty. The results were presented at the annual meeting of the European Association for the Study of Diabetes in Madrid.
In the essay, 56 children received daily injections of up to 3 milligrams of liraglutide for almost 13 monthswhile 26 received dummy drugs. The children were followed for six months afterwards.
All children received individual counseling to help them follow a plan that included a healthy diet and 60 minutes a day of moderate- to high-intensity exercise.
Researchers found that children who took the drug for more than a year saw their body mass index (a measure of height and weight that can account for a child’s natural growth) drop by 5.8%. Children who received the dummy drug saw their BMI increase by 1.6%.
At the same time, children who received the drug slowed weight gain to 1.6% of their body weight over that period, compared with a 10% gain for those who received dummy drugs.
The study found that 46% of children who received the drug reduced their BMI by at least 5%, an amount that has been linked to improvements in obesity-related health problems. In children who received a placebo, 9% reached that mark. Lower blood pressure and blood sugar levels were detected in children who received the drug, the researchers said.
Side effects, mostly mild to moderate, were reported in almost 90% of both groups of participants. Side effects have been reported Gastrointestinal side effects, including nausea and vomiting, occurred in 80% of children given the drug, compared with 54% of those given dummy drugs. Serious side effects were reported in seven children taking liraglutide and two taking placebo. Six participants taking the drug dropped out of the trial because of side effects, while none taking placebo discontinued treatment.
At six-month follow-up, children in both groups who stopped treatment increased their BMI and gained weight, the study found. The trial has been expanded to include more treatment and follow-up, with results expected in 2027.
Fox receives research funding from Novo Nordisk and is paid directly by the drugmaker Eli Lilly. Those companies are also conducting trials of more potent weekly injections of Novo’s Wegovy and Lilly’s Zepbound in children as young as 6 years old.
Dr. Alaina Vidmar, a pediatric obesity specialist at Children’s Hospital Los Angeles who was not involved in the new study, said she has used liraglutide off-label to treat young children and would welcome drug approval to increase flexibility and access.
The drug treats the underlying physiology of obesity, which is a chronic and complex disease that can occur at any age.
Its early use can prevent obesity and other health problems potentially life-threatening diseases extend into adolescence and adulthood.
“We want these kids to live long, healthy lives,” Vidmar said. “The sooner we can start, the more likely we are to prevent them from developing early-onset diabetes, early-onset heart disease, sleep apnea and all those things. Doing nothing is not the right answer.”
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