Oral Semaglutide in an East Asian Population With Overweight or Obesity, With or Without Type 2 Diabetes
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Le résumé fourni par la source
Importance: The efficacy and safety of oral semaglutide, 50 mg, in an East Asian population that also includes individuals with type 2 diabetes (T2D), who are prone to weight-related complications at lower body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) thresholds than other ethnic groups, is currently unknown. Objective: To assess the efficacy and safety of once-daily oral semaglutide, 50 mg, for the treatment of overweight and obesity in East Asian individuals with or without T2D. Design, Setting, and Participants: The OASIS 2 trial was a 68-week (plus 7 weeks of follow-up) multicenter, double-blind, placebo-controlled phase 3a randomized clinical trial conducted from November 2021 to September 2023 in Japan and South Korea. Adults with a BMI of 27.0 or greater with 2 or more related complications or a BMI of 35.0 or greater with 1 or more related complications were enrolled. Approximately 25% of participants were planned to have T2D at screening. Data were analyzed from March 2022 to July 2025. Interventions: Participants were assigned 2:1 to once-daily oral semaglutide, 50 mg, or placebo, plus lifestyle recommendations, for 68 weeks. Main Outcomes and Measures: The coprimary end points were percentage change in body weight from baseline and the proportion of participants who achieved 5% or greater body weight reductions. Changes in physical function, cardiometabolic risk factors, and safety were also evaluated. Results: Overall, 201 participants (mean [SD] age, 49 [11] years; mean [SD] body weight, 91.9 [18.2] kg; 87 [43.3%] female; 51 [25.4%] with T2D) were randomized to semaglutide (n = 134) or placebo (n = 67). The mean (SEM) percentage change in body weight was -14.3% (0.8) with semaglutide vs -1.3% (1.1) with placebo (estimated treatment difference, -13.07 percentage points; 95% CI, -15.61 to -10.52; P < .001). More participants had 5% or greater body weight reductions with semaglutide vs placebo (107 of 127 [84.3%] vs 11 of 64 [17.2%]; odds ratio, 23.00; 95% CI, 10.28-51.42; P < .001). Gastrointestinal tract adverse events were reported by 85 of 134 participants (63.4%) with semaglutide and 23 of 66 with placebo (34.8%). Adverse events led to treatment discontinuation in 6 of 134 participants (4.5%) in the semaglutide arm. Conclusions and Relevance: In this randomized clinical trial, among East Asian adults with overweight or obesity, with or without T2D, oral semaglutide, 50 mg, led to a superior and clinically meaningful reduction in body weight compared with placebo, with a safety profile consistent with the glucagon-like peptide-1 receptor agonist class. Trial Registration: ClinicalTrials.gov Identifier: NCT05132088.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Oral Semaglutide in an East Asian Population With Overweight or Obesity, With or Without Type 2 Diabetes
- Date Crossref
- 01/10/2025
- Éditeur
- American Medical Association (AMA)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Oasis Hospital pays non établi dans la noticeÉtablissement de santé
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Toranomon Hospital pays non établi dans la noticeÉtablissement de santé
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Novo Nordisk (Denmark) pays non établi dans la noticeEntreprise
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Kyungpook National University Hospital pays non établi dans la noticeÉtablissement de santé
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The University of Osaka pays non établi dans la noticeUniversité ou école supérieure
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Novo Nordisk (India) pays non établi dans la noticeEntreprise
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Gachon University Gil Medical Center pays non établi dans la noticeÉtablissement de santé
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for the OASIS 2 Investigators pays non établi dans la noticeInstitution
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Kyungpook National University School of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Graduate School of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Gachon University College of Medicine pays non établi dans la noticeUniversité ou école supérieure
Oasis Hospital, Toranomon Hospital et Novo Nordisk (Denmark), avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.