Study Shows Saxenda Weight-Loss Drug Effective for Kids Aged 6 and Up

A recent study has shown that a medication designed for treating obesity in adults and teenagers is also effective and safe for young children as young as six years old, particularly when paired with diet and exercise.

The drug, liraglutide, demonstrated a decrease in body mass, a slowdown in weight gain, and marked improvements in various health indicators for children aged 6 to 11. These findings were presented at a medical conference and published in the New England Journal of Medicine.

In light of these promising results, the drug’s manufacturer, Novo Nordisk, has approached U.S. regulatory authorities to consider expanding the drug’s approval for this younger demographic. If sanctioned, liraglutide would become the first medication authorized for the treatment of the most prevalent type of obesity affecting over 20% of American children aged between 6 and 11, as reported by the U.S. Centers for Disease Control and Prevention.

Dr. Claudia Fox, a pediatric obesity specialist at the University of Minnesota and the study’s lead researcher, noted that options for children suffering from obesity have been severely limited. Historically, such children have simply been advised to adopt stricter dietary habits and increase their physical activity.

While encouraging, the study also highlighted some concerns. Side effects, especially gastrointestinal issues such as nausea, vomiting, and diarrhea, were reported frequently among the participants receiving liraglutide. Medical professionals and parents must weigh these potential adverse effects against the limited data regarding the long-term implications of using such medications in younger populations.

Dr. Melissa Crocker, a pediatric obesity expert at Boston Children’s Hospital who was not involved in the research, expressed cautious optimism. “Having a medication for that age group, if approved, would be a really nice tool to have, but we’re also going to have to be careful about how widely we start using it,” she said, suggesting a different approach may be necessary for children aged 6 compared to those who are 11.

Liraglutide belongs to a category of drugs known as GLP-1 receptor agonists, which also includes popular medications like Wegovy and Mounjaro. These drugs mimic hormones that regulate appetite, fullness, and digestion. Liraglutide is administered as a daily injection and is already approved under the brand Victoza for diabetes treatment in adults and children aged 10 and older, as well as as Saxenda for obesity treatment in individuals aged 12 to 17.

The new study, funded by Novo Nordisk, involved 82 pediatric participants with an average age of 10 years and a starting weight of approximately 155 pounds. Their average body mass index (BMI) was 31, indicating they were classified as obese. More than half of these children had obesity-related health issues, such as insulin resistance and asthma. The findings were presented at an annual meeting of the European Association for the Study of Diabetes held in Madrid.

During the study, 56 children received daily injections of up to 3 milligrams of liraglutide for nearly 13 months, while 26 received a placebo. Following the treatment, the children were observed for an additional six months.

All participating children received personalized counseling to encourage adherence to a healthy diet and to engage in at least 60 minutes of physical activity daily.

As a result, children who received liraglutide for over a year saw their BMI decrease by 5.8%, while those on the placebo experienced a 1.6% increase. The liraglutide group also moderated their weight gain to just 1.6% of their body weight during the study, compared to a 10% increase for the placebo group.

Notably, 46% of those receiving the liraglutide treatment achieved a BMI reduction of at least 5%, a significant benchmark associated with health improvements related to obesity. Conversely, only 9% of the placebo group managed this outcome. Additionally, measurements indicated lower blood pressure and blood sugar levels in the liraglutide group.

Side effects were reported in nearly 90% of participants across both groups, with gastrointestinal issues affecting around 80% of those on the drug compared to 54% of placebo recipients. Serious side effects occurred in seven children receiving liraglutide and in two from the placebo group. Notably, six participants on the drug discontinued their participation due to side effects, while no one in the placebo group did.

The study also tracked BMI changes during the six-month follow-up post-treatment. Both groups who halted treatment saw an increase in BMI and weight regain. The trial has been prolonged to encompass further treatment periods and follow-up assessments, with anticipated results expected in 2027.

Dr. Alaina Vidmar, a pediatric obesity specialist from Children’s Hospital Los Angeles who was not part of the study, has previously utilized liraglutide off-label for young children and expressed support for formal approval to enhance treatment options and accessibility.

By addressing the physiological aspects of obesity, a complicated chronic disease that can manifest at any age, the earlier intervention can help prevent obesity and associated serious health issues in adolescence and adulthood.

Dr. Vidmar emphasized the importance of prompt action and stated, “We want these kids to have long, healthy lives. The sooner that we can start, the more likely we can stop them from getting early onset diabetes, early onset heart disease, sleep apnea—all of those things. Doing nothing is not the right answer.”

Source: AP News