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A Novo Nordisk weight-loss drug is safe and effective in children as young as six, according to a new company-funded study, paving the way for liraglutide to become the first treatment for obesity to be made available to the age group.
Children aged 6 to 12 using the injectable pens for just over a year saw a 7.4 per cent reduction in their body-mass index compared with those on a placebo, according to the trial.
Liraglutide is a diabetes and weight-loss treatment in the same GLP-1 class of drugs as Novo Nordisk’s blockbuster Ozempic and Wegovy treatments.
The results in the study, which involved 82 children, come as Novo Nordisk of Denmark and US rival Eli Lilly seek to expand the use of GLP-1s by showing their benefits in also tackling diseases linked to obesity, such as heart disease, and developing pill versions of the products to be taken orally.
Martin Holst Lange, the company’s head of development, said the drugmaker will seek regulatory approval from the US Food and Drug Administration and from the European Medicines Agency to expand the use of liraglutide to under-12s.
“One in five children have obesity and one of the biggest predictors for adult obesity is childhood obesity so having this potential intervention for that age group is important,” Lange told the Financial Times.
Participants in the trial had previously undergone lifestyle treatment that had proved ineffective.
There are currently no pharmaceutical treatments approved for general obesity in under-12s — as opposed to that found with some rare genetic disorders — said Claudia Fox, a professor from University of Minnesota Medical School who led the study, which will also be published in the New England Journal of Medicine.
Novo Nordisk is also testing semaglutide — the active ingredient in Ozempic and Wegovy — for young children. The treatment is already approved for over-12s and delivers higher weight loss than liraglutide.
But as with adults, the drug did lead to side effects of nausea and vomiting, and those who stopped using it regained weight quickly, a sign of the limitations in treating obesity through drugs.
However, Fox said there were no differences between the control group on placebos and those on liraglutide in terms of growth, changes in bone age or issues with puberty.
“That does provide some comfort but . . . we need much longer-term data and much bigger numbers. We’ll see whether the FDA say if this is adequate for regulatory approval or not,” Fox said.
New analysis by data provider PitchBook suggests the obesity drug market will peak at $200bn in value, with Novo Nordisk and US company Eli Lilly set to continue to dominate the sector despite rivals such as Roche and Amgen launching challenger products.
The Danish drugmaker has invested heavily in research and development to come up with successor treatments to Ozempic and Wegovy.
One potential candidate watched closely by analysts is amycretin, a drug that combines the effects of GLP-1, a hormone found in the gut, with amylin, a hormone in the pancreas that also affects appetite regulation.
At a diabetes conference in Madrid, the Danish company also unveiled early data for a daily oral pill called amycretin. Users on a maximum dose lost 13 per cent of their body weight over three months, without the fall levelling off.
While stressing that the data was early, Lange said the drug “has potential that is on a par with CagriSema”, another Novo Nordisk product in later-stage trials it believes could provide 25 per cent weight loss, compared to around 15 per cent for Wegovy and around 20 per cent provided by Eli Lilly’s Mounjaro drug.
However, he said there was “no doubt” the pill would require higher amounts of active pharmaceutical ingredients compared to injectable pens, adding to pressure on the company’s supply chains. Wegovy and Ozempic have repeatedly suffered shortages due to high demand for the drugs.
Naveed Sattar, professor of metabolic medicine at Glasgow University, said the data on amycretin was “exciting given the speed of weight loss seen” but that “far larger-scale trials” would be needed to test the medicine’s potential.