Semaglutide – the drug in blockbuster anti-obesity drug Wegovy – along with a lifestyle intervention led to a “substantial reduction” in the body mass index of obese adolescents after more than a year of weekly treatments, researchers reported Wednesday in the New England Journal of Medicine.
Wegovy is currently available by prescription only for adults in the United States. The new study looked at whether it can work in teenagers.
“Boy, does this happen,” said NBC News medical contributor Dr. Natalie Azar.
The study involved 201 obese participants in the United States and other countries between the ages of 12 and 17 and were randomly assigned to receive either a weekly injection of semaglutide or a placebo. The dose of the drug was the same as the dose approved for adults.
Both groups also received a lifestyle intervention consisting of nutrition and physical activity counseling for weight loss before and during the study.
After 16 months of this routine, teens in the semaglutide group lost an average of nearly 15 percent of their body weight, or about 34 pounds, while kids in the control group gained about 5 pounds.
“Not only did they lose weight, they had an improvement in their waistline, they had an improvement in cholesterol,” Azar said. It was also one of the first studies to examine how adolescents’ quality of life improved as they lost weight, “and it improved dramatically,” she noted. . “Having that extra weight can have a significant impact on their social development.”
The research was funded by Novo Nordisk, the pharmaceutical giant that makes Wegovy.
Emmalea Zummo, a 17-year-old from Jeannette, Pennsylvania, was one of the teens enrolled in the study who received semaglutide. She weighed 250 pounds at the start, weight gain linked to polycystic ovary syndrome, and lost more than 70 pounds during the trial.
“I felt better about myself than I had ever felt before,” she told NBC News.
The safety profile of semaglutide in obese adolescents in the trial was consistent with that seen in adults, the researchers wrote. The drug “does not appear to affect pubertal growth or development,” they noted.
“There are no developmental issues, but with any drug there are side effects. The main side effects of this class of drugs are GI (gastrointestinal) – nausea, vomiting, diarrhea,” said today Dr. Silva Arslanian, scientific director of the Center for Pediatric Obesity and Metabolism Research at Children’s Hospital of Pittsburgh, is a co-author of the study.
“None of our participants had disrupted school work. But of course it is very individual.
Almost two-thirds of teenagers taking semaglutide, 62%, experienced gastrointestinal side effects, compared to 42% of teenagers taking a placebo.
Semaglutide belongs to a class of drugs called GLP-1 receptor agonists and works by mimicking a natural hormone that the body releases when a person eats food. This hormone targets areas of the brain that regulate appetite and food intake. Researchers believe its action in the brain helps people feel full sooner, so they eat less than usual.
It works better for weight loss in obese adolescents than the lifestyle intervention alone for several reasons, including the fact that hunger and satiety are driven by the central nervous system, Arslanian said.
Additionally, “we live in an obesogenic environment where healthy lifestyle choices are not so easy to implement…(and) healthy daily physical activity has been replaced by non-screen-burning activities. calories,” she noted.
The teenagers had no difficulty injecting the drug, “but if you know or have teenagers, parents usually need to watch or remind them of whatever life tasks they are doing,” said noted Arslanian.
The drug costs about $1,300 a month, and health insurance often doesn’t cover obesity drugs. Patients must keep taking it for it to work, otherwise they may regain the weight they lost.
Asked if there were any concerns about young patients starting this drug so early in life and taking it indefinitely, Arslanian said: “It’s a really good question that’s on the radar. from everyone. I am sure that with new scientific advances, we will be able to find a solution.
Semaglutide has been in the news a lot lately. It is also the active ingredient in Ozempic, a prescription drug to treat type 2 diabetes and Wegovy’s sister drug. Ozempic has not been approved for weight loss, but many people who don’t have diabetes use it off-label – the practice of taking an approved drug for unapproved use – and credit it with their success. weightloss.
Demand for both drugs impacts supply. The United States Food and Drug Administration lists Wegovy and Ozempic as “currently in short supply” on its website.
Novo Nordisk is experiencing supply shortages from Wegovy due to “unprecedented product demand and near-term manufacturing issues,” the company noted on its website. He asked doctors to suspend treatment of new patients with the drug for now, but said he was on track to make all doses available in the United States by the end of this year.
FDA approval for using semaglutide for weight loss in obese teens could come in 2023, Azar said.
This article originally appeared on TODAY.com