Obesity drug liraglutide is safe and effective in children under 12, study finds

The anti-obesity drug liraglutide is safe and effective in children aged 6 to <12 years, new research is presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain (9 -13 September), and published. at the same time in New England Journal of Medicine (NEJM)you have found.

A six- to 12-year-old child who took liraglutide for more than a year had a 7.4% reduction in BMI compared to placebo and had improvements in blood pressure and blood sugar control.

The results of the SCALE Kids trial, the first study to examine the safety and efficacy of liraglutide in a pediatric population, offer hope that children living with obesity can lead healthier, more productive lives, say researchers.

Lead author Professor Claudia Fox, from the Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis, USA, says: “Obesity is the most common chronic disease of childhood. associated with serious illness, including diabetes and heart disease, and for some, early intervention is important.

“However, effective treatments so far are limited. The mainstay of obesity treatment is lifestyle therapy – changes in diet and exercise – but when used alone, the effect is moderate and, although Thus, there are no medications approved for the general treatment of obesity in children under 12 years of age.

“Liraglutide is approved as an adjunct to lifestyle therapy in adults and adolescents with obesity, and in this study, we evaluated its safety and efficacy in people under 12 years of age.”

Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It mimics the action of a hormone called GLP-1 to reduce appetite and feelings of hunger, delay the release of food from the stomach and increase the feeling of fullness after eating and is given daily another, as a vaccine.

A phase 3 study, funded by liraglutide manufacturer Novo Nordisk, included 82 children (53.7% male) aged 6 to <12 years. At baseline, the average age was 10 years, BMI was 31.0 kg/m² and weight was 70.2 kg (11st 1lb). 54.9% of children had ≥1 obesity-related problem, such as insulin resistance or puberty or early puberty.

56 children received daily injections of liraglutide (3mg or maximum tolerated dose) and 26 received weekly injections of placebo for 56 weeks. All participants received counseling each person on each trip to encourage adherence to a healthy diet and regular exercise (with a goal of 60 minutes a day of moderate to vigorous intensity exercise).

At the end of the treatment period, the mean change in BMI was -5.8% for liraglutide and +1.6% for placebo – a difference of 7.4%.

The mean change in body weight was +1.6% for liraglutide and +10% for placebo – a difference of 8.4%.

A reduction in BMI of at least 5% was seen in 46.2% of children receiving liraglutide and 8.7% receiving placebo.

Children of this age are constantly growing, so weight can be expected to increase during the year. BMI takes height into account, as well as weight, and is more informative, say the researchers.

Professor Fox says: “Although there is no consensus on the definition of a meaningful BMI reduction in children, a reduction of 5% has been shown to be associated with improvement in some obesity-related health conditions.

“In our study, diastolic blood pressure and hemoglobin A1c [HbA1c]A measure of blood sugar control was significantly better in children receiving liraglutide than in those receiving placebo.”

Side effects were common in both groups (89.3% of liraglutide recipients and 88.5% of placebo recipients). Gastrointestinal side effects (eg, nausea, vomiting, diarrhea) were the most common and occurred in 80.4% of children receiving liraglutide and 53.8% receiving placebo.

12.5% ​​of liraglutide recipients and 7.7% of placebo recipients had adverse effects. Four of the 7 adverse events in the liraglutide group were gastrointestinal and 10.7% of those in the liraglutide group discontinued treatment due to side effects, compared with the placebo group.

This is consistent with what has been seen in young adults and adults taking liraglutide.

BMI and body weight increased in both groups after treatment stopped.

The researchers concluded that liraglutide 3.0mg led to a greater reduction in BMI than placebo in six to 12-year-old children living with obesity. Liraglutide was well tolerated and there were no new safety concerns.

The results of this study offer great promise for children living with obesity.

Until now, there have been no methods to treat obesity. They are told to ‘try hard’ with diet and exercise.

Now with the availability of medications that address the underlying cause of obesity, there is hope that children living with obesity can live healthier and more productive lives.“

Professor Claudia Fox, Principal Secretary, Center for Pediatric Obesity Medicine, University of Minnesota School of Medicine, Minneapolis, USA