Subcutaneous semaglutide, at a 2.4 mg once-weekly maintenance dose, is approved in the United States for weight management in individuals with a body mass index (BMI) of 30 kg/m² or higher, or with a BMI of 27 kg/m² or higher and at least one obesity-related co-morbidity. To investigate the usability of the semaglutide pen-injector in individuals who met these criteria, we report post hoc analysis of the summative (human factors validation) usability testing and safety analysis involving patients with type 2 diabetes (an obesity-related co-morbidity) with the same pen-injector, limited to the 26 out of 30 patients with a BMI of 27 kg/m² or higher (11 pen-injector–naïve, 15 pen-injector–experienced) and 15 non-pharmacist healthcare professionals (HCPs). Participants performed two simulated injections into an injection pad. No potentially serious use errors occurred. Mean subjective ease-of-use rating on a seven-point scale, where 1 = difficult and 7 = easy, was 6.9 for the second injection in all three groups. These results suggest that the semaglutide pen-injector is easy to use and not associated with serious use errors when used by pen-injector–naïve or pen-injector–experienced patients meeting the requirement for weight management with semaglutide treatment, and by non-pharmacist HCPs.

中文翻译：

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索马鲁肽单剂量笔式注射器：体重管理总结性可用性测试的事后分析

皮下注射 semaglutide，每周一次 2.4 mg 维持剂量，在美国被批准用于体重指数 (BMI) 为 30 kg/m ²或更高或 BMI 为 27 kg/m 的个体的体重管理^{2 项}或以上和至少一种肥胖相关的合并症。为了调查符合这些标准的个人使用 semaglutide 笔式注射器的可用性，我们报告了对 2 型糖尿病患者（肥胖相关的合并症）的总结性（人为因素验证）可用性测试和安全性分析的事后分析使用相同的笔式注射器，仅限于 30 名 BMI 为 27 kg/m ^{2 的}患者中的 26^名或更高（11 名笔式注射器新手，15 名笔式注射器经验丰富）和 15 名非药剂师医疗保健专业人员 (HCP)。参与者对注射垫进行了两次模拟注射。没有发生潜在的严重使用错误。在所有三组中，第二次注射的七分制的平均主观易用性评分，其中 1 = 困难，7 = 容易，均为 6.9。这些结果表明，当满足使用司美鲁肽治疗体重管理要求的笔式注射器 - 未使用或有笔式注射器经验的患者以及非药剂师使用时，司美鲁肽笔式注射器易于使用且不会出现严重的使用错误医护人员。