Findings from a part 3 trial evaluating semaglutide in adolescents with weight problems confirmed that therapy with the glucagon-like peptide-1 receptor agonist resulted in important reductions in physique mass index (BMI) vs way of life intervention alone.
The STEP TEENS research (ClinicalTrials.gov Identifier: NCT04102189) included 201 members 12 to lower than 18 years of age with weight problems or who had been chubby with no less than 1 weight-related comorbidity (eg, hypertension, dyslipidemia, obstructive sleep apnea, or sort 2 diabetes). Sufferers had been randomly assigned 2:1 to obtain semaglutide 2.4mg administered once-weekly by subcutaneous injection or placebo for 68 weeks, along with way of life intervention. The first endpoint of the research was the share change in BMI from baseline to week 68.
A complete of 180 adolescents (179 of whom had been labeled as overweight) accomplished therapy. At week 68, the imply change in BMI from baseline within the semaglutide group was -16.1%, whereas within the placebo group, it was 0.6% (estimated distinction, -16.7 proportion factors; 95% CI, -20.3, -13.2; P <.001). Moreover, extra sufferers handled with semaglutide skilled weight lack of 5% or extra (secondary endpoint; 73% vs 18% for placebo; estimated odds ratio, 14.0; 95% CI, 6.3-31.0; P <.001).
Enhancements in waist circumference, HbA1c, lipids (apart from high-density lipoprotein ldl cholesterol), and liver enzymes had been additionally noticed with semaglutide in contrast with placebo.
Within the semaglutide group, 62% of sufferers reported gastrointestinal adversarial occasions and 4% had cholelithiasis, in contrast with 42% and 0% of sufferers within the placebo arm, respectively.
“The outcomes are wonderful,” stated senior creator Silva Arslanian, MD, professor of pediatrics and scientific and translational science and who holds the Richard L. Day Endowed Chair in Pediatrics on the College of Pittsburgh Faculty of Medication. “For an individual who’s 5 foot, 5 inches tall and weighs 240 kilos, the common discount in BMI equates to shedding about 40 kilos.”
Semaglutide is at the moment authorized by the Meals and Drug Administration (FDA) underneath the model identify Wegovy as an adjunct to a lowered calorie weight-reduction plan and elevated bodily exercise for persistent weight administration in grownup sufferers with an preliminary BMI of 30kg/m2 or larger (weight problems) or 27kg/m2 or larger (chubby) within the presence of no less than 1 weight-related comorbid situation (eg, hypertension, sort 2 diabetes mellitus, or dyslipidemia).
Wegovy, which is manufactured by Novo Nordisk, is at the moment in short supply. Based on the Firm, further manufacturing of Wegovy is predicted in 2023. The scarcity has additionally resulted in supply constraints of one other Novo Nordisk product, Ozempic. The sort 2 diabetes therapy additionally comprises semaglutide.
References
- Weghuber D, Barrett T, Barrientos-Pérez M, et al. Once-weekly semaglutide in adolescents with obesity. N Engl J Med. Revealed on-line November 2, 2022. doi:10.1056/NEJMoa2208601
- Weight problems drug helps teenagers drop some weight, research finds. Information launch. November 2, 2022. Accessed November 3, 2022. https://www.eurekalert.org/news-releases/970040
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