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Novo's older obesity drug is safe and effective for children, study finds
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Novo's older obesity drug is safe and effective for children, study finds
Sep 11, 2024 4:28 AM

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.

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