By Maggie Fick
LONDON (Reuters) - Novo Nordisk's older weight-loss drug Saxenda helped children between the ages of 6 and under 12 reduce their body mass index by 7.4% in a 56-week trial, according to results presented at a medical meeting on Wednesday.
The Novo-sponsored study was the first to examine the safety and efficacy of once daily injections of Saxenda, known chemically as liraglutide, in young children.
No medications are currently approved for the treatment of obesity in children under age 12, though Saxenda was approved for adolescents in 2020 and for adults in 2014. Novo said it has applied with U.S. and European regulators to expand the approval to include the ages involved in this study.
The trial of 92 children met its primary endpoint of BMI reduction for those on liraglutide, as well as secondary endpoints including weight loss, compared with a placebo. BMI is a measure of body fat based on height and weight that helps define if a person is overweight or obese.
Results were presented at the European Association for the Study of Diabetes meeting in Madrid and published in the New England Journal of Medicine.
“To date, children have had virtually no options for treating obesity. They have been told to ‘try harder’ with diet and exercise," said lead researcher Professor Claudia Fox, of the Center for Pediatric Obesity Medicine, University of Minnesota Medical School in Minneapolis.
"Now with the possibility of a medication that addresses the underlying physiology of obesity, there is hope that children living with obesity can live healthier, more productive lives.”
Children taking the medicine also experienced improvements in blood pressure and blood glucose control than those who got a placebo, researchers reported.
Liraglutide, also used to treat type 2 diabetes under the brand name Victoza, belongs to the first generation of drugs known as GLP-1 agonists, which curb appetite as well as help control blood sugar. It results in less weight loss on average than Novo's newer in-demand Wegovy, which launched in 2020 and was approved for adolescents ages 12 and older in 2022.
Booming sales of Wegovy (semaglutide) have propelled the Danish drugmaker's market value to the highest of all European companies.
Experts said liraglutide was likely chosen for the children study because it has been in use for many years with a well-established safety record.
Given that safe and effective treatments to help obese children are needed, "it seems likely that we see more trials in this age group, and that they will involve the use of increasingly more effective weight-loss drugs," said Stephen O'Rahilly, professor of clinical biochemistry and medicine at the University of Cambridge.
In the trial, gastrointestinal side effects - a known issue with GLP-1 drugs - were common and led to discontinuation of 10% of trial participants who were on the treatment before the end of the study.
During a follow-up period after the 56 weeks, BMI and body weight increased in both groups, researchers reported.
Both Novo and U.S. rival Eli Lilly, the only drugmakers with highly effective obesity medicines on the market, are testing their weight-loss treatments in children as young as 6.
(Reporting by Maggie Fick in London; Editing by Bill Berkrot)
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