Semaglutide — the medication in the blockbuster anti-obesity drug Wegovy — plus lifestyle intervention led to a “substantial reduction” in the body mass index of obese teenagers 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 U.S. The new study looked at whether it can work in adolescents.
“Boy, does it ever,” said NBC News medical contributor Dr. Natalie Azar.
The study involved 201 participants with obesity in the U.S. and other countries who were 12 to 17 years old and were randomly assigned to receive either a once-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 lifestyle intervention consisting of nutrition and physical activity counseling for weight loss before and during the study.
After 16 months of this routine, the teens in the group taking semaglutide lost an average of almost 15% of their body weight, or about 34 pounds, while the kids in the control group gained about 5 pounds.
“Not only did they lose the weight, they had an improvement in their waist circumference, they had an improvement in cholesterol,” Azar said. It was also one of the first studies to look at how the teens’ quality of life improved as they lost weight, “and it improved dramatically,” she noted. “Having that extra weight can be 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, a weight gain that was related to polycystic ovary syndrome, and lost more than 70 pounds during the trial.
“I felt better within my own skin, which is something I never felt before,” she told NBC News.
The safety profile of semaglutide among teens with obesity in the trial was consistent with that seen in adults, the researchers wrote. The drug “did not appear to affect growth or pubertal development,” they noted.
“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, told TODAY. She’s a co-author of the study.
“None of our participants had schoolwork disrupted. But of course, it is very individual.”
Almost two-thirds of the teens taking semaglutide, 62%, experienced gastrointestinal adverse events, compared to 42% of teens taking a placebo.
Semaglutide is in a class of drugs called GLP-1 receptor agonists and works by mimicking a natural hormone 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 satiated earlier, so they eat less than they usually would.
It works better for weight loss for teens with obesity than lifestyle intervention alone for several reasons, including the fact that hunger and satiety are driven by the central nervous system, Arslanian said.
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 noted.
The teens didn’t have any difficulty 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 noted.
The drug is expensive at about $1,300 a month and health insurance often doesn’t cover anti-obesity drugs. Patients have to keep taking it for it to work, otherwise they can regain the weight the lost.
When asked if there were any concerns about young patients starting this medication so early in life and taking it indefinitely, Arslanian said, “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 news a lot lately. It’s also the active ingredient in Ozempic, a prescription medication 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 are using it off-label — the practice of taking an approved drug for unapproved use — and crediting it for their weight-loss success.
The demand for both drugs is impacting supply. The U.S. Food and Drug Administration lists Wegovy and Ozempic as “currently in shortage” on its website.
Novo Nordisk is experiencing Wegovy supply shortages due to “unprecedented product demand and short-term manufacturing issues,” the company noted on its website. It has asked doctors to hold off starting new patients on the drug for now, but said it’s on track to make all dose strengths available in the U.S. towards the end of this year.
FDA approval for semaglutide use for weight loss in teens with obesity might come in 2023, Azar said.