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Data from the STEP TEENS trial indicate the weight loss benefits obtained with semaglutide 2.4 mg (Wegovy) in adults also translate to younger populations as well.
A randomized clinical trial assessing the effects of a once weekly, 2.4 mg dose of subcutaneous semaglutide in people with obesity or overweight aged 12 and older but younger than 18 years of age, results of the study indicate use of semaglutide was associated with a mean weight loss of 16.1% of body weight at 68 weeks among this patient population, with 73% of recipients losing 5% or more of their baseline body weight.
“Rates of obesity are increasing, not just in the U.S., but all over the world,” said senior investigator Silva Arslanian, MD, professor of pediatrics and clinical and translational science and the Richard L. Day Endowed Chair in Pediatrics at the University of Pittsburgh School of Medicine, in a statement from Novo Nordisk. “Typically, we make lifestyle recommendations: Eat more vegetables; don’t eat fried food; don’t drink soda. But unfortunately, we live in a very obesogenic environment, so it can be very hard to make those changes. There is a real need for safe and effective medications to treat obesity.”
With approval as an adjunct to diet and exercise for weight loss in adult populations with overweight or obesity, semaglutide 2.4 mg ushered in a new era for weight loss. With clinicians treating diabetes already familiar with injectable GLP-1 receptor agonists and the increased dosage formulation backed by data from the STEP program, which assessed the agent for weight loss in populations with and without diabetes, semaglutide 2.4 mg has been welcomed by clinicians and patients eager to reap the purported benefits of use.
Although a shortage has hampered uptake, it has not dampened the fervor and enthusiasm surrounding the potential impact of optimized uptake on a population level. This enthusiasm, combined with a growing obesity crisis among teens and adolescents in the US, have prompted questions related to potential use in younger populations. With this in mind, STEP TEENS was designed as a double-blind, parallel-group, randomized, placebo-controlled trial that enrolled individuals aged from 12 to less than 18 years of age with obesity or overweight with at least 1 other weight-related condition.
A total of 201 individuals from 37 sites were identified for inclusion from October 2019 through March 2022. These individuals were randomized in a 2:1 ratio to receive once-weekly, subcutaneous 2.4 mg semaglutide or placebo for 68 weeks as adjuncts to lifestyle intervention. The primary outcome of interest for the study was the percentage change in BMI from baseline to week 68. The secondary outcome of interest for the study was the proportion of participants with a weight loss of at least 5% at week 68.
The overall study cohort was 38% male, 36% were younger than 15 years of age, 64% were 15 years of age or older, and 79% were White. Investigators pointed out all but 1 participant had obesity. Investigators also noted baseline characteristics were similar between those randomized to semaglutide and placebo, except for body weight, BMI, and waist circumference, which were slightly greater among those randomized to semaglutide.
At the end of the 68-week study period, results indicated the mean change in BMI from baseline to week 68 was -16.1% among those receiving semaglutide 2.4 mg and 0.6% among those receiving placebo therapy (estimated difference, -16.7 percentage points [95% CI, -20.3 to -13.2]; P <.001). When assessing the secondary outcome of interest, investigators found 73% of those randomized to semaglutide experienced a weight loss of 5% or greater compared to just 18% of those randomized to placebo (OR, 14.0 [95% CI, 6.3 to 31.0]; P <.001). Further analysis of weight loss outcomes suggested a weight loss of 20% or greater occurred among 37% of adolescents receiving semaglutide compared with just 3% receiving placebo therapy. In additional analyses, investigators observed other apparent benefits of semaglutide use, such as reductions in body weight and improvement in cardiometabolic risk factors, including waist circumference, levels of glycated hemoglobin, lipids, and alanine aminotransferase, were greater with semaglutide than with placebo.
When assessing safety outcomes, results suggested the incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs 42%). Instances of cholelithiasis were observed among 4 randomized to semaglutide, with no instances reported among those receiving placebo therapy. Additionally, serious adverse events were reported among 11% of the semaglutide group and 9% of the placebo group.
“The results are amazing,” added Arslanian, who also serves as director of the Pediatric Clinical and Translational Research Center and scientific director of the Center for Pediatric Research in Obesity and Metabolism at Pitt and UPMC Children’s Hospital of Pittsburgh. “For a person who is 5 foot, 5 inches tall and weighs 240 pounds, the average reduction in BMI equates to shedding about 40 pounds.”
This study, “Once-Weekly Semaglutide in Adolescents with Obesity,” was published in the New England Journal of Medicine.