Novo Nordisk A/S, Søborg, Denmark.
Parexel International GmbH, Berlin, Germany.
Diabetes Obes Metab. 2024 Oct;26(10):4480-4489. doi: 10.1111/dom.15802. Epub 2024 Jul 31.
To investigate the effects of once-daily oral semaglutide 50 mg on energy intake, appetite, control of eating and gastric emptying.
A clinical pharmacology, double-blind study was conducted in 61 adults with obesity randomized to once-daily oral semaglutide (dose-escalated to 50 mg) or placebo for 20 weeks. Energy intake was measured during an ad libitum lunch, and participant-reported appetite ratings and Control of Eating Questionnaire responses were assessed. Gastric emptying was measured using paracetamol absorption following a standardized breakfast.
The relative change from baseline in ad libitum energy intake at week 20 (primary endpoint) was -39.2% points (95% confidence interval -59.0%, -19.4%) with semaglutide compared with placebo. Body weight was reduced by 9.8% with semaglutide and by 1.5% with placebo. Semaglutide reduced hunger, increased fullness and satiety, and was associated with fewer food cravings and better control of eating versus placebo. No statistically significant difference in gastric emptying was observed at week 20.
In participants with obesity, once-daily oral semaglutide 50 mg reduced energy intake, body weight and appetite, and improved control of eating. There was no evidence of delayed gastric emptying at week 20, as measured through paracetamol absorption.
研究每日口服司美格鲁肽 50mg 对能量摄入、食欲、摄食控制和胃排空的影响。
在 61 名肥胖成年人中进行了一项临床药理学、双盲研究，他们被随机分为每日口服司美格鲁肽（剂量递增至 50mg）或安慰剂组，治疗 20 周。在自由进食午餐期间测量能量摄入，评估参与者报告的食欲评分和摄食控制问卷的反应。使用标准化早餐后对乙酰氨基酚吸收来测量胃排空。
与安慰剂相比，第 20 周时（主要终点）司美格鲁肽治疗组的自由进食能量摄入的相对基线变化为-39.2 个点（95%置信区间-59.0%，-19.4%）。司美格鲁肽组体重减轻了 9.8%，安慰剂组体重减轻了 1.5%。司美格鲁肽降低了饥饿感，增加了饱腹感和满足感，与安慰剂相比，减少了食物渴望，更好地控制了饮食。在第 20 周时，胃排空没有观察到统计学上的显著差异。
在肥胖参与者中，每日口服司美格鲁肽 50mg 可减少能量摄入、体重和食欲，并改善摄食控制。通过对乙酰氨基酚吸收测量，在第 20 周时没有证据表明胃排空延迟。
