In a secondary evaluation of the STEP TEENS trial, semaglutide proved to be a big therapy for adolescent weight problems, with 45% of the semaglutide-treated individuals shedding sufficient weight to drop beneath the weight problems cutoff, and 74% moved down a minimum of one BMI class after 68 weeks.
Almost Half of Adolescents Utilizing Semaglutide in Trial Dropped Beneath the Medical Lower-Off for Weight problems
A secondary evaluation of the STEP TEENS trial, printed within the Weight problems journal and offered on the European Congress on Weight problems 2023, has discovered that semaglutide is efficient in treating weight problems in adolescents. Almost half (45%) of the individuals handled with semaglutide managed to lose sufficient weight to be categorised beneath the weight problems cutoff, and about three-quarters (74%) skilled a drop in a minimum of one physique mass index (BMI) class. The trial initially concerned 201 adolescents with excessive BMIs, who have been randomized into teams receiving both a placebo or weekly semaglutide injections alongside way of life 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 offered at this 12 months’s European Congress on Weight problems (ECO 2023, Dublin 17-20 Could) and printed within the journal Weight problems exhibits that nearly half (45%) of the adolescents assigned to semaglutide within the trial managed to lose sufficient weight to drop beneath the medical cutoff for weight problems.
The research, led by Aaron S. Kelly, PhD, co-director of the Heart for Pediatric Weight problems Drugs on the College of Minnesota, Minneapolis, and colleagues, additionally confirmed nearly three quarters (74%) moved down by a minimum of one weight class.
The complete STEP TEENS trial, printed in 2022 within the New England Journal of Drugs (NEJM), confirmed the efficacy of semaglutide in serving to adolescents drop some pounds. On this secondary evaluation of the STEP TEENS trial, the authors examined the impact of semaglutide therapy on enchancment in physique mass index (BMI) classes.
On June 4, 2021, the U.S. Meals and Drug Administration authorised Wegovy (semaglutide) injection (2.4 mg as soon as weekly) for persistent weight administration in adults with weight problems or obese with a minimum of one weight-related situation (akin to hypertension, kind 2 diabetes, or excessive ldl cholesterol), to be used along with a diminished calorie weight loss program and elevated bodily exercise.
Adolescents aged 12 to underneath 18 years with BMI within the highest 5% have been included on this evaluation. Individuals 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 way of life counseling. The proportion of individuals who achieved an enchancment in BMI class from baseline to week 68 was assessed utilizing on-treatment knowledge.
BMI classes, based mostly on Facilities for Illness Management and Prevention BMI charts, have been: regular weight (BMI ≥fifth to <eighty fifth percentile); obese (BMI ≥eighty fifth to <ninety fifth percentile); and weight problems class I (OCI; BMI ≥ninety fifth percentile). Extreme weight problems class II (OCII) and sophistication III (OCIII) are based mostly on a proportion above the ninety fifth 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 physique weight was 107.5 kg and imply BMI was 37.0 kg/m2 (OCII).
At week 68, 74% of individuals 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 individuals handled with semaglutide versus 3% with placebo. Total, therapy with semaglutide diminished the proportion of individuals with probably the most extreme diploma of weight problems (OCIII) from 37% to 14% after 68 weeks.
By week 68, a complete of 45% individuals within the semaglutide arm skilled a discount in BMI beneath the medical cutoff level for weight problems (i.e., reached regular weight or obese) versus 12% of individuals within the placebo arm.
The authors concluded, “As soon as-weekly semaglutide was related to clinically significant enhancements in BMI classes versus PBO throughout all BMI lessons in adolescents with weight problems.”
“These outcomes underscore the excessive diploma of medical effectiveness of semaglutide in adolescents with weight problems,” mentioned Kelly. “In a sensible sense, we see that semaglutide diminished weight to a stage beneath what’s outlined as medical weight problems in almost 50% of the kids in our trial, which is traditionally unprecedented with therapies aside from bariatric surgical procedure.”
Kelly offered this research at ECO 2023 on Wednesday, Could 17, 2023.
References:
“Decreasing BMI beneath the weight problems threshold in adolescents handled 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 Could 2023, Weight problems.
DOI: 10.1002/oby.23808
“As soon as-Weekly Semaglutide in Adolescents with Weight problems” by Daniel Weghuber, M.D., Timothy Barrett, Ph.D., Margarita Barrientos-Pérez, M.D., Inge Gies, Ph.D., Dan Hesse, Ph.D., Ole Okay. 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 Drugs.
DOI: 10.1056/NEJMoa2208601
