Findings from a phase 3 trial evaluating semaglutide in adolescents with obesity showed that treatment with the glucagon-like peptide-1 receptor agonist resulted in significant reductions in body mass index (BMI) vs lifestyle intervention alone.

The STEP TEENS study (ClinicalTrials.gov Identifier: NCT04102189) included 201 participants 12 to less than 18 years of age with obesity or who were overweight with at least 1 weight-related comorbidity (eg, hypertension, dyslipidemia, obstructive sleep apnea, or type 2 diabetes). Patients were randomly assigned 2:1 to receive semaglutide 2.4mg administered once-weekly by subcutaneous injection or placebo for 68 weeks, in addition to lifestyle intervention. The primary endpoint of the study was the percentage change in BMI from baseline to week 68.

A total of 180 adolescents (179 of whom were classified as obese) completed treatment. At week 68, the mean change in BMI from baseline in the semaglutide group was -16.1%, while in the placebo group, it was 0.6% (estimated difference, -16.7 percentage points; 95% CI, -20.3, -13.2; P <.001). Additionally, more patients treated with semaglutide experienced weight loss of 5% or more (secondary endpoint; 73% vs 18% for placebo; estimated odds ratio, 14.0; 95% CI, 6.3-31.0; P <.001).

Improvements in waist circumference, HbA1c, lipids (except for high-density lipoprotein cholesterol), and liver enzymes were also observed with semaglutide compared with placebo.

In the semaglutide group, 62% of patients reported gastrointestinal adverse events and 4% had cholelithiasis, compared with 42% and 0% of patients in the placebo arm, respectively.

“The results are amazing,” said senior author Silva Arslanian, MD, professor of pediatrics and clinical and translational science and who holds the Richard L. Day Endowed Chair in Pediatrics at the University of Pittsburgh School of Medicine. “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.”

Semaglutide is currently approved by the Food and Drug Administration (FDA) under the brand name Wegovy as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30kg/m2 or greater (obesity) or 27kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).

Wegovy, which is manufactured by Novo Nordisk, is currently in short supply. According to the Company, additional production of Wegovy is expected in 2023. The shortage has also resulted in supply constraints of another Novo Nordisk product, Ozempic. The type 2 diabetes treatment also contains semaglutide.

References

  1. Weghuber D, Barrett T, Barrientos-Pérez M, et al. Once-weekly semaglutide in adolescents with obesity. N Engl J Med. Published online November 2, 2022. doi:10.1056/NEJMoa2208601
  2. Obesity drug helps teens lose weight, study finds. News release. November 2, 2022. Accessed November 3, 2022. https://www.eurekalert.org/news-releases/970040