Once-Weekly Semaglutide in Adolescents with Obesity | NEJM - nejm.org

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Abstract

Background

A once-weekly, 2.4-mg dose of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, is utilized to dainty obesity successful adults, but appraisal of the cause successful 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 scale [BMI] successful the 95th percentile oregon higher) oregon with overweight (a BMI successful the 85th percentile oregon higher) and astatine slightest 1 weight-related coexisting condition. Participants were randomly assigned successful a 2:1 ratio to person once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) oregon placebo for 68 weeks, positive manner intervention. The superior extremity constituent was the percent alteration successful BMI from baseline to week 68; the secondary confirmatory extremity constituent was value nonaccomplishment of astatine slightest 5% astatine week 68.

Results

A full of 201 participants underwent randomization, and 180 (90%) completed treatment. All but 1 of the participants had obesity. The mean alteration successful BMI from baseline to week 68 was −16.1% with semaglutide and 0.6% with placebo (estimated difference, −16.7 percent points; 95% assurance interval [CI], −20.3 to −13.2; P<0.001). At week 68, a full of 95 of 131 participants (73%) successful the semaglutide radical had value nonaccomplishment of 5% oregon more, arsenic compared with 11 of 62 participants (18%) successful the placebo radical (estimated likelihood ratio, 14.0; 95% CI, 6.3 to 31.0; P<0.001). Reductions successful assemblage value and betterment with respect to cardiometabolic hazard 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%) successful the semaglutide radical and nary participants successful the placebo radical had cholelithiasis. Serious adverse events were reported successful 15 of 133 participants (11%) successful the semaglutide radical and successful 6 of 67 participants (9%) successful the placebo group.

Conclusions

Among adolescents with obesity, once-weekly attraction with a 2.4-mg dose of semaglutide positive manner involution resulted successful a greater simplification successful BMI than manner involution alone. (Funded by Novo Nordisk; STEP TEENS ClinicalTrials.gov number, NCT04102189.)

Funding and Disclosures

Supported by Novo Nordisk.

Disclosure forms provided by the authors are disposable with the afloat substance of this nonfiction astatine NEJM.org.

This nonfiction was published connected November 2, 2022, astatine NEJM.org.

A data sharing statement provided by the authors is disposable with the afloat substance of this nonfiction astatine NEJM.org.

We convey the proceedings participants and their parents oregon guardians; the investigators and proceedings tract unit who conducted the trial; Lucy Cooper (advanced caregiver practitioner) and the National Institute for Health and Care Research Wellcome Clinical Research Facility, Birmingham Women’s and Children’s Hospital (Birmingham, United Kingdom), for their enactment connected recruiting and retaining participants and conducting the proceedings successful Birmingham; Christina Egebjerg (Novo Nordisk) for assistance with mentation of the information data; and Sophie Walton (Axis, a part of Spirit Medical Communications Group) and Ruth Lloyd (a declaration writer moving connected behalf of Axis), for aesculapian penning assistance with an earlier draught of the manuscript (funded by Novo Nordisk).

Author Affiliations

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 astatine Buffalo, Buffalo, NY (L.D.M.); and the Center for Pediatric Research successful 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.).

Dr. Weghuber tin beryllium contacted astatine [email protected] oregon astatine the Department of Pediatrics, Paracelsus Medical University, Müllner Hauptstrasse 48, 5020 Salzburg, Austria.

A implicit database of investigators successful the STEP TEENS proceedings is provided successful the Supplementary Appendix, disposable astatine NEJM.org.