Semaglutide significantly effective for weight loss in teenagers too: NEJM Study
Austria: Semaglutide is an obesity drug that mimics a hormone called glucagon-like peptide-1 to target areas of the brain that decrease appetite and help control eating. Semaglutide was approved for chronic weight management in adults with obesity or overweight in 2021.
A recent study has found that once-weekly treatment with a 2.4-mg dose of semaglutide combined with lifestyle intervention led to a more significant reduction in BMI than lifestyle intervention alone among adolescents with obesity. According to top-line results presented at ObesityWeek 2022, Once-weekly semaglutide alongside lifestyle intervention resulted in a body mass index (BMI) reduction of 16.1% from baseline at 68 weeks among adolescents with obesity.
The study has been published in the New England Journal of Medicine.
Once-weekly 2.4-mg dose of a glucagon-like peptide-1 receptor agonist, subcutaneous semaglutide, is used for obesity treatment in adults, but there is a lack of drug assessment in adolescents. Considering this, Daniel Weghuber, Paracelsus Medical University in Salzburg, Austria, and colleagues conducted a double-blind, parallel-group, randomized, placebo-controlled trial.
Adolescents aged 12 to <18 years with obesity having a BMI in the 95th percentile or higher or with overweight having a BMI in the 85th percentile or higher and the presence of at least one weight-related coexisting condition were enrolled in the study. Participants were randomly assigned in a ratio of 2:1 to receive once-weekly subcutaneous semaglutide at a 2.4 mg dose or placebo for 68 weeks, combined with lifestyle intervention.
The percentage endpoint was the percentage BMI change from baseline to week 68, and weight loss of at least 5% at week 68 was the secondary confirmatory endpoint.
The study led to the following findings:
- Two hundred-one participants underwent randomization, and the treatment was completed by 90%. All but one of the adolescents had obesity.
- The mean BMI change from baseline to week 68 was −16.1% with semaglutide, and with placebo, it was 0.6% (estimated difference, −16.7 percentage points).
- 73% in the semaglutide group had a weight loss of 5% or more at week 68, compared with 18% in the placebo group (estimated odds ratio, 14.0).
- The researchers observed more significant reductions in body weight and improvement regarding cardiometabolic risk factors (levels of glycated hemoglobin and waist circumference, lipids, and alanine aminotransferase) with semaglutide compared to placebo.
- With semaglutide, a greater incidence of gastrointestinal adverse events was seen than with a placebo (62% vs. 42%).
- 4% in the semaglutide group had cholelithiasis, and none of the participants in the placebo group had it.
- Serious adverse events were reported in 11% of the semaglutide group and 9% of the placebo group.
"In obese adolescents, once-weekly treatment with a 2.4-mg dose of semaglutide combined with lifestyle intervention led to a greater reduction in BMI than lifestyle intervention alone," researchers wrote in their conclusion.
The limitations included the low proportions of ethnic minorities, a high number of female participants, and the small number of participants with type 2 diabetes.
Reference:
Weghuber D, Barrett T, Barrientos-Pérez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sørrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Nov 2. doi: 10.1056/NEJMoa2208601. Epub ahead of print. PMID: 36322838.
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