LONDON, Sept 11 (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 ( LLY ), the only
drugmakers with highly effective obesity medicines on the
market, are testing their weight-loss treatments in children as
young as 6.