Semaglutide — the treatment in the blockbuster anti-obesity drug Wegovy — plus way of life intervention led to a “substantial reduction” in the physique mass index of overweight youngsters after greater than a 12 months of weekly therapies, researchers reported Wednesday in The New England Journal of Medicine.
Wegovy is at present out there by prescription just for adults in the U.S. The new examine checked out whether or not it may possibly work in adolescents.
“Boy, does it ever,” stated NBC News medical contributor Dr. Natalie Azar.
The examine concerned 201 individuals with weight problems in the U.S. and different nations who have been 12 to 17 years previous and have been randomly assigned to obtain both a once-weekly injection of semaglutide or a placebo. The dose of the drug was the identical because the dose accredited for adults.
Both teams additionally acquired way of life intervention consisting of diet and bodily exercise counseling for weight reduction earlier than and throughout the examine.
After 16 months of this routine, the kids in the group taking semaglutide misplaced a median of virtually 15% of their physique weight, or about 34 kilos, whereas the children in the management group gained about 5 kilos.
“Not only did they lose the weight, they had an improvement in their waist circumference, they had an improvement in cholesterol,” Azar stated. It was additionally one of many first research to have a look at how the kids’ high quality of life improved as they misplaced weight, “and it improved dramatically,” she famous. “Having that extra weight can be a significant impact on their social development.”
The analysis was funded by Novo Nordisk, the pharmaceutical large that makes Wegovy.
Emmalea Zummo, a 17-year-old from Jeannette, Pennsylvania, was one of many teenagers enrolled in the examine who acquired semaglutide. She weighed 250 kilos firstly, a weight achieve that was associated to polycystic ovary syndrome, and misplaced greater than 70 kilos throughout the trial.
“I felt better within my own skin, which is something I never felt before,” she told NBC News.
The security profile of semaglutide amongst teenagers with weight problems in the trial was constant with that seen in adults, the researchers wrote. The drug “did not appear to affect growth or pubertal development,” they famous.
“There are no developmental concerns, but with any medication there are side effects. The main side effects of this class of medications is GI (gastrointestinal) — nausea, vomiting, diarrhea,” Dr. Silva Arslanian, scientific director of the Center for Pediatric Research in Obesity & Metabolism at Children’s Hospital of Pittsburgh, informed TODAY. She’s a co-author of the examine.
“None of our participants had schoolwork disrupted. But of course, it is very individual.”
Almost two-thirds of the kids taking semaglutide, 62%, skilled gastrointestinal antagonistic occasions, in contrast to 42% of teenagers taking a placebo.
Semaglutide is in a category of medication known as GLP-1 receptor agonists and works by mimicking a pure hormone the physique releases when an individual eats meals. This hormone targets areas of the mind that regulate urge for food and meals consumption. Researchers imagine its motion in the mind helps individuals really feel satiated earlier, in order that they eat lower than they normally would.
It works higher for weight reduction for teenagers with weight problems than way of life intervention alone for a number of causes, together with the truth that starvation and satiety are pushed by the central nervous system, Arslanian stated.
Also, “we live in an obesogenic environment where healthy lifestyle choices are not so easy to implement… (and) healthy routine daily physical activity has been replaced with screen activities that do not burn calories,” she famous.
The teenagers didn’t have any problem self-injecting the drug, “but if you know or have teens, parents typically have to monitor or remind them no matter what life-tasks they are performing,” Arslanian famous.
The drug is pricey at about $1,300 a month and medical insurance typically doesn’t cowl anti-obesity medicine. Patients have to preserve taking it for it to work, in any other case they’ll regain the burden the misplaced.
When requested if there have been any considerations about younger sufferers beginning this treatment so early in life and taking it indefinitely, Arslanian stated, “this is a very good question that is on everyone’s radar. I am sure with further scientific advancements we will be able to figure out a solution.”
Semaglutide has been in the information lots these days. It’s additionally the lively ingredient in Ozempic, a prescription treatment to deal with Type 2 diabetes and Wegovy’s sister drug. Ozempic has not been accredited for weight reduction, however many individuals who don’t have diabetes are utilizing it off-label — the observe of taking an accredited drug for unapproved use — and crediting it for his or her weight-loss success.
Novo Nordisk is experiencing Wegovy provide shortages due to “unprecedented product demand and short-term manufacturing issues,” the corporate famous on its website. It has requested docs to maintain off beginning new sufferers on the drug for now, however stated it’s on observe to make all dose strengths out there in the U.S. in the direction of the tip of this 12 months.
FDA approval for semaglutide use for weight reduction in teenagers with weight problems would possibly come in 2023, Azar stated.
This article was initially printed on TODAY.com