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Once-Weekly Semaglutide in Adolescents with Obesity
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BACKGROUND: A once-weekly, 2.4-mg dose of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, is used to treat obesity in adults, but assessment of the drug in adolescents has been lacking. METHODS: In this double-blind, parallel-group, randomized, placebo-controlled trial, we enrolled adolescents (12 to <18 years of age) with obesity (a body-mass index [BMI] in the 95th percentile or higher) or with overweight (a BMI in the 85th percentile or higher) and at least one weight-related coexisting condition. Participants were randomly assigned in a 2:1 ratio to receive once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo for 68 weeks, plus lifestyle intervention. The primary end point was the percentage change in BMI from baseline to week 68; the secondary confirmatory end point was weight loss of at least 5% at week 68. RESULTS: A total of 201 participants underwent randomization, and 180 (90%) completed treatment. All but one of the participants had obesity. The mean change in BMI from baseline to week 68 was -16.1% with semaglutide and 0.6% with placebo (estimated difference, -16.7 percentage points; 95% confidence interval [CI], -20.3 to -13.2; P<0.001). At week 68, a total of 95 of 131 participants (73%) in the semaglutide group had weight loss of 5% or more, as compared with 11 of 62 participants (18%) in the placebo group (estimated odds ratio, 14.0; 95% CI, 6.3 to 31.0; P<0.001). Reductions in body weight and improvement with respect to cardiometabolic risk factors (waist circumference and levels of glycated hemoglobin, lipids [except high-density lipoprotein cholesterol], and alanine aminotransferase) were greater with semaglutide than with placebo. The incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%). Five participants (4%) in the semaglutide group and no participants in the placebo group had cholelithiasis. Serious adverse events were reported in 15 of 133 participants (11%) in the semaglutide group and in 6 of 67 participants (9%) in the placebo group. CONCLUSIONS: Among adolescents with obesity, once-weekly treatment with a 2.4-mg dose of semaglutide plus lifestyle intervention resulted in a greater reduction in BMI than lifestyle intervention alone. (Funded by Novo Nordisk; STEP TEENS ClinicalTrials.gov number, NCT04102189.).
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“Approved by FDA/EMA from age 12.”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [113]
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“73% achieved ≥ 5% weight loss and with significant amelioration of CVD factors (e.g. waist circumference, ALT and HbA1c) and no adverse impact on pubertal development and bone health [113].”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [113]
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“Similar efficacy was achieved with once-weekly subcutaneous injections of 2.4 mg semaglutide in the STEP Teens trial among adolescents aged 12–18 years [80]”
From New Developments in Pharmacological Treatment of Obesity and Type 2 Diabetes—Beyond and within GLP-1 Receptor Agonists (2024) · cites this paper as [80]
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“In the STEP TEENS trial, adolescents achieved a − 16.1% mean BMI reduction vs. + 0.6% in the placebo group.”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [113]
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“Similar efficacy was achieved with 2.4 mg once weekly injections in adolescents with comorbidities (STEP Teens) and with a high dose (50 mg once daily) of the oral formulation of semaglutide in adults (OASIS-1) [24, 25].”
From Recent advances in peptide-based therapies for obesity and type 2 diabetes (2024) · cites this paper as [24]
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“However, weight loss was less amongst obese individuals with T2DM (eg 9.6% weight loss with the 2.4 mg once weekly injected semaglutide in STEP-2) for likely reasons described above [17, 24, 25].”
From Recent advances in peptide-based therapies for obesity and type 2 diabetes (2024) · cites this paper as [24]
In the citing paper
“the main trials for which data have been published (STEP 1 through STEP 5, STEP 8, and STEP TEENS) did not include participants who reported having symptoms of major depressive disorder within 2 years before screening, which limits their ability to assess psychiatric adverse events in people with a recent history of depression [3,4,93,94,95,96,97].”
From What Is Food Noise? A Conceptual Model of Food Cue Reactivity (2023) · cites this paper as [97]
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“STEP TEENS studied semaglutide 2.4 mg in adolescents living with obesity and reported that semaglutide versus placebo resulted in a 17.7-kg weight loss over 68 weeks (Table 3B).76”
From Management of type 2 diabetes, obesity, or nonalcoholic steatohepatitis with high‐dose GLP‐1 receptor agonists and GLP‐1 receptor‐based co‐agonists (2024) · cites this paper as [76]
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Metadata
- Authors
- Weghuber, D., Barrett, T., Barrientos-Pérez, M., Gies, I., Hesse, D., Jeppesen, O. K., Kelly, A. S., Mastrandrea, L. D., Sørrig, R., & Arslanian, S.
- Affiliations
- University of Minnesota (US)
- From the Department of Pediatrics, Paracelsus Medical University, Salzburg, Austria (D.W.); the Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, United Kingdom (T.B.); the Division of Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Søborg, Denmark (D.H., O.K.J., R.S.); the Department of Pediatrics and the Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Diabetes, and Metabolism, University of Pittsburgh School of Medicine, and UPMC Children’s Hospital of Pittsburgh, Pittsburgh (S.A.).
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-12-15
- Volume
- 387
- Issue
- 24
- Pages
- 2245-2257
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC9997064
- OpenAlex
- W4308053954
- Cited by
- 730
- References
- 26
- Citations by year
- 2026: 217 · 2025: 199 · 2024: 189 · 2023: 120 · 2022: 5
- FWCI
- 76.74
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (publishedVersion)
- PubMed Central (acceptedVersion)
- Lirias (KU Leuven) (submittedVersion, other-oa)
- Digital Access to Libraries (submittedVersion, other-oa)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- Novo Nordisk A/S
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- semaglutide, adolescents, adolescent obesity, overweight, GLP-1 receptor agonists, weight loss, body mass index, cardiometabolic risk factors, lifestyle intervention, gastrointestinal adverse effects, gallstones, drug safety, weight-related comorbidities, HbA1c, alanine aminotransferase, waist circumference, serum lipids, serious adverse events
- MeSH terms
- Healthy Lifestyle, Glucagon-Like Peptide-1 Receptor Agonists, Semaglutide, Administration, Cutaneous, Adolescent, Child, Double-Blind Method, Humans, Weight Loss, Body Mass Index, Anti-Obesity Agents, Pediatric Obesity
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