Nearly Half of Adolescents Using Semaglutide in Trial Dropped Below the Clinical Cut-Off for Obesity
A secondary evaluation of the STEP TEENS trial, revealed in the Obesity journal and introduced at the European Congress on Obesity 2023, has discovered that semaglutide is efficient in treating weight problems in adolescents. Nearly half (45%) of the contributors handled with semaglutide managed to lose sufficient weight to be labeled under the weight problems cutoff, and about three-quarters (74%) skilled a drop in a minimum of one body mass index (BMI) class. The trial initially concerned 201 adolescents with high BMIs, who have been randomized into teams receiving both a placebo or weekly semaglutide injections alongside life-style counseling for 68 weeks. After this era, the semaglutide group demonstrated important enhancements in BMI classes in comparison with the placebo group, with a marked discount in these with extreme weight problems.
A brand new secondary evaluation of the STEP TEENS trial introduced at this yr’s European Congress on Obesity (ECO 2023, Dublin 17-20 May) and revealed in the journal Obesity reveals that nearly half (45%) of the adolescents assigned to semaglutide in the trial managed to lose sufficient weight to drop under the scientific cutoff for weight problems.
The research, led by Aaron S. Kelly, PhD, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis, and colleagues, additionally confirmed virtually three quarters (74%) moved down by a minimum of one weight class.
The full STEP TEENS trial, revealed in 2022 in the New England Journal of Medicine (NEJM), confirmed the efficacy of semaglutide in serving to adolescents lose weight. In this secondary evaluation of the STEP TEENS trial, the authors examined the impact of semaglutide therapy on enchancment in body mass index (BMI) classes.
On June 4, 2021, the U.S. Food and Drug Administration authorized Wegovy (semaglutide) injection (2.4 mg as soon as weekly) for continual weight administration in adults with weight problems or obese with a minimum of one weight-related situation (corresponding to high blood pressure, kind 2 diabetes, or high ldl cholesterol), to be used along with a lowered calorie eating regimen and elevated bodily exercise.
Adolescents aged 12 to underneath 18 years with BMI in the highest 5% have been included on this evaluation. Participants have been randomized 2:1 to once-weekly subcutaneous semaglutide 2.4 mg (n=134) or placebo (n=67) for 68 weeks; each teams acquired matching life-style counseling. The proportion of contributors who achieved an enchancment in BMI class from baseline to week 68 was assessed utilizing on-treatment knowledge.
BMI classes, primarily based on Centers for Disease Control and Prevention BMI charts, have been: regular weight (BMI ≥fifth to <85th percentile); obese (BMI ≥85th to <95th percentile); and weight problems class I (OCI; BMI ≥95th percentile). Severe weight problems class II (OCII) and sophistication III (OCIII) are primarily based on a share above the 95th percentile cutoff for weight problems – OCII is outlined as ≥20% above this cutoff and OCIII is outlined as ≥40% above this cutoff.
Of 201 adolescents randomized, 62 (31%), 69 (34%) and 69 (34%) have been in OCIII, OCII and OCI, respectively; just one participant (0.5%) had obese and was excluded from this secondary evaluation. At randomization, imply body weight was 107.5 kg and imply BMI was 37.0 kg/m2 (OCII).
At week 68, 74% of contributors on semaglutide had an enchancment of a number of BMI classes versus 19% on placebo. An enchancment of ≥2 BMI classes occurred in 45% of contributors handled with semaglutide versus 3% with placebo. Overall, therapy with semaglutide lowered the proportion of contributors with the most extreme diploma of weight problems (OCIII) from 37% to 14% after 68 weeks.
By week 68, a complete of 45% contributors in the semaglutide arm skilled a discount in BMI under the scientific cutoff level for weight problems (i.e., reached regular weight or obese) versus 12% of contributors in the placebo arm.
The authors concluded, “Once-weekly semaglutide was associated with clinically meaningful improvements in BMI categories versus PBO across all BMI classes in adolescents with obesity.”
“These results underscore the high degree of clinical effectiveness of semaglutide in adolescents with obesity,” stated Kelly. “In a practical sense, we see that semaglutide reduced weight to a level below what is defined as clinical obesity in nearly 50% of the teens in our trial, which is historically unprecedented with treatments other than bariatric surgery.”
Kelly introduced this research at ECO 2023 on Wednesday, May 17, 2023.
“Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg” by Aaron S. Kelly, Silva Arslanian, Dan Hesse, Aske Thorn Iversen, Antje Körner, Signe Schmidt, Rasmus Sørrig, Daniel Weghuber and Ania M. Jastreboff, 17 May 2023, Obesity.
“Once-Weekly Semaglutide in Adolescents with Obesity” by Daniel Weghuber, M.D., Timothy Barrett, Ph.D., Margarita Barrientos-Pérez, M.D., Inge Gies, Ph.D., Dan Hesse, Ph.D., Ole Ok. Jeppesen, M.Sc., Aaron S. Kelly, Ph.D., Lucy D. Mastrandrea, M.D., Rasmus Sørrig, Ph.D., and Silva Arslanian, M.D. for the STEP TEENS Investigators, 15 December 2022, The New England Journal of Medicine.