Home » News » Drugs in the Pipeline Publish Date November 3, 2022 Semaglutide Reduces BMI Extra Than Way of life Adjustments in Teenagers With Weight problems Diana Ernst, RPh Share on Facebook Share on Twitter Share on LinkedIn Share on Reddit Print Share by Email Semaglutide is at present authorised by the FDA to be used in adults with weight problems beneath the model title Wegovy.
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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 life-style intervention alone.
The STEP TEENS examine (ClinicalTrials.gov Identifier: NCT04102189 ) included 201 members 12 to lower than 18 years of age with weight problems or who had been obese with no less than 1 weight-related comorbidity (eg, hypertension, dyslipidemia, obstructive sleep apnea, or kind 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 life-style intervention.
The first endpoint of the examine was the share change in BMI from baseline to week 68.
A complete of 180 adolescents (179 of whom had been categorised 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 share 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 (aside 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 hostile 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 present authorised by the Meals and Drug Administration (FDA) beneath the model title Wegovy as an adjunct to a diminished calorie food regimen and elevated bodily exercise for persistent weight administration in grownup sufferers with an preliminary BMI of 30kg/m 2 or better (weight problems) or 27kg/m 2 or better (obese) within the presence of no less than 1 weight-related comorbid situation (eg, hypertension, kind 2 diabetes mellitus, or dyslipidemia).
Wegovy, which is manufactured by Novo Nordisk, is at present 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 kind 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 .
Printed on-line November 2, 2022. doi:10.1056/NEJMoa2208601 Weight problems drug helps teenagers drop pounds, examine finds.
Information launch.
November 2, 2022.
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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 life-style intervention alone.
The STEP TEENS examine (ClinicalTrials.gov Identifier: NCT04102189 ) included 201 members 12 to lower than 18 years of age with weight problems or who had been obese with no less than 1 weight-related comorbidity (eg, hypertension, dyslipidemia, obstructive sleep apnea, or kind 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 life-style intervention.
The first endpoint of the examine was the share change in BMI from baseline to week 68.
A complete of 180 adolescents (179 of whom had been categorised 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 share 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 (aside 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 hostile 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 present authorised by the Meals and Drug Administration (FDA) beneath the model title Wegovy as an adjunct to a diminished calorie food regimen and elevated bodily exercise for persistent weight administration in grownup sufferers with an preliminary BMI of 30kg/m 2 or better (weight problems) or 27kg/m 2 or better (obese) within the presence of no less than 1 weight-related comorbid situation (eg, hypertension, kind 2 diabetes mellitus, or dyslipidemia).
Wegovy, which is manufactured by Novo Nordisk, is at present 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 kind 2 diabetes therapy additionally comprises semaglutide.
References Please login or register first to view this content material.
Login Register Copyright © 2022 Haymarket Media, Inc.
All Rights Reserved This materials is probably not printed, broadcast, rewritten or redistributed in any type with out prior authorization.
Your use of this web site constitutes acceptance of Haymarket Media’s Privacy Policy and Terms & Conditions . source