FDA Greenlights Diabetes Drug to Treat Teens With Obesity

The U.S. Food and Drug Administration (FDA) has approved semaglutide, a type 2 diabetes drug that recently gained social media fame, for weight loss for teenagers with obesity.

The drug, approved under the brand name Wegovy, is so far the only prescription anti-obesity medicine for children as young as 12 with once-a-week injection, according to Novo Nordisk, the company that produces Wegovy. It is also sold under other names such as Ozempic and Rybelsus.

The recommended dose of Wegovy in children is 2.4 mg, and it should be used with a reduced calorie meal plan and increased physical activity to lose weight and keep it off, Novo Nordisk said.

The most common side effects of Wegovy include nausea, vomiting, diarrhea, headache, and abdominal pain, the company noted. Adolescents treated with Wegovy saw an increased incidence of gallbladder problems compared to adults, including gallstones, low blood pressure, rash, and itching.

Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake, according to FDA, which in 2021 approved Wegovy injection for weight loss in adults with obesity or overweight.

The FDA decision to approve Wegovy for use in teenagers came after a Novo Nordisk-funded study found semaglutide to be as effective in adolescents with obesity as it is in adults with obesity.

For the study, published in December 2022 in The New England Journal of Medicine, an international team of scientists conducted a double-blind, randomized, placebo-controlled trial on 201 adolescents ranging from 12 to 18 years old. The participants, who all have obesity or are overweight with at least one weight-related condition, received either semaglutide or placebo once a week for a span of 68 weeks, during which they also practiced lifestyle interventions.

At week 68, according to the study, a total of 95 of 131 participants (73 percent) in the semaglutide group had weight loss of 5 percent or more, as compared with 11 of 62 participants (18 percent) in the placebo group. Overall, participants who received semaglutide lost an average of 16.1 percent of their initial body weight compared to a 0.6 percent increase in individuals who received placebo.

When it comes to adverse reactions, the incidence of gastrointestinal adverse events was greater with semaglutide (62 percent) than with placebo (42 percent). Five participants in the semaglutide group and no participants in the placebo group had cholelithiasis, or gallstones. Serious adverse events were reported in 15 participants in the semaglutide group and in 6 of the placebo group.

About 4.5 million children and adolescents in the United States have obesity, according to the U.S. Centers for Disease Control and Prevention (CDC).

In December 2022, the CDC updated the Body Mass Index (BMI) chart that doctors have been using to estimate whether a child’s body mass composition is considered healthy compared to the broader population. For instance, a 16-year-old boy who is 5 feet, 8 inches tall and weighs 240 pounds would have a BMI of 36.5 and be described as severely obese.

The previous BMI chart for children, published in 2000, stopped at a BMI of 37. The new chart has been extended to BMI measurements of up to 60 to reflect the increasing number of children with severe obesity.