Local obese teenagers experienced dramatic weight loss when they participated in the UB clinical trial

BUFFALO, NY – For teenagers struggling with obesity, it probably sounded too good to be true: a weekly injection that could help them control their eating and lead to weight loss.

But the results of the clinical trial of the drug semaglutide, published online ahead of print Nov. 3 in the New England Journal of Medicine and presented at the discipline’s major conference, Obesity Week, turned out to be better than anything participants — or even researchers — expected. .

Participants who received the weekly injection of the glucagon-like peptide-1 (GLP) receptor agonist semaglutide saw an average reduction in their body mass index (BMI) percentage of 16.1% compared to 0.6% with placebo, results to which the suppliers responded with surprise. and enthusiasm, and which the national media described as “amazing” and “amazing”.

University at Buffalo researchers who worked on the study chose more reserved language to describe the results, but were equally impressed.

“We knew it was an effective weight loss drug because of what we learned from using it in adult patients,” said Lucy Mastrandrea, MD, PhD, co-author of the NEJM study and chief of the Division of Pediatric Endocrinology in the Department of Pediatrics at UB Jacobs School of Medicine and Biomedical Sciences. “However, the weight loss I saw from the combination of this drug and lifestyle changes was so dramatic it was almost a little disturbing.

“This work is advancing the field of obesity management in pediatric patients, and we’re doing it here in Buffalo.”

Mastrandrea, who sees patients through UBMD Pediatrics, has led previous national trials of other drugs that have been approved by the FDA to help children and teens with type 1 and type 2 diabetes achieve better blood sugar control. She also led the study that led to another NEJM publication in 2020 that showed liraglutide, another GLP agonist, produced weight loss in children and adolescents.

The UB researchers’ success in recruiting and retaining participants for that study led to Mastrandrea’s participation in the adolescent semaglutide study.

A great research team

“We were one of the leading academic medicine groups in the semaglutide study to recruit and retain subjects,” she said. In total, the study included 37 sites nationwide with 229 participants. “Our success in recruiting and retaining participants is due to the experienced UBMD Pediatrics research team.”

Five Western New York adolescents between the ages of 13 and 17 were recruited, and four completed the trial. “We’ve had a tremendous retention rate, both here in Buffalo and nationally,” Mastrandrea said. “These teenagers stuck with it because they saw results.”

During the year the study was conducted, of the four patients in Buffalo who were randomized to receive the drug, all lost at least 5 percent of their body weight; In the overall study, 73% of study participants treated with semaglutide lost at least 5% of their body weight.

“These were people who worked hard, some of them for years, to try to manage their weight with just diet and exercise, which are the main tools we had,” Mastrandrea said.

“We usually say ‘try to lose a pound or two a week,'” she said, “so when patients were losing up to 20 pounds after 6-8 weeks, that was huge,” she said. “The patients were very happy. They would say things like, “It was so hard before and now it works. I feel better about myself. I’m buying new clothes.'”

Participants also showed improved levels of triglycerides and other cardiometabolic measures, as well as improved measures of quality of life.

While the previous study with liraglutide, another drug in the same class, also resulted in significant weight loss for teenagers, semaglutide’s results were dramatic, according to Mastrandrea. “We didn’t compare the two drugs, but in a population of similar age, with a similar degree of obesity, this study did show a better response in terms of weight loss,” she said.

Reducing hunger

Semaglutide works by binding to the glucagon peptide receptor, which delays gastric emptying. “We think this mechanism feeds into the brain’s appetite centers in the hypothalamus so that the person doesn’t feel as hungry,” explained Mastrandrea.

The study included a 12-week lifestyle intervention period that required participants to participate in moderate activity at least five times a week and follow healthy eating habits.

Mastrandrea believes that the results participants saw from the drug may have positively influenced their level of participation in the lifestyle intervention, leading to further weight loss.

“I think as people see success with weight loss, they start to change their behaviors,” she said. “They may have become more comfortable with incorporating exercise into their lives in a more consistent way, so the drug may have had a positive impact on their healthy behaviors.”

Mastrandrea sees patients at UBMD Pediatrics; her practice is affiliated with the Healthy Weigh Clinic at John R. Oishei Children’s Hospital.

The study was funded by Novo Nordisk, which makes semaglutide.

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