Novo Nordisk A/S, Søborg, Denmark.
Parexel International GmbH, Berlin, Germany.
Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3.
To investigate the effects of once-weekly subcutaneous (s.c.) semaglutide 2.4 mg on gastric emptying, appetite, and energy intake in adults with obesity.
A double-blind, parallel-group trial was conducted in 72 adults with obesity, randomized to once-weekly s.c. semaglutide (dose-escalated to 2.4 mg) or placebo for 20 weeks. Gastric emptying was assessed using paracetamol absorption following a standardized breakfast. Participant-reported appetite ratings and Control of Eating Questionnaire (CoEQ) responses were assessed, and energy intake was measured during ad libitum lunch.
The area under the concentration-time curve (AUC) for paracetamol 0 to 5 hours after a standardized meal (AUC ; primary endpoint) was increased by 8% (P = 0.005) with semaglutide 2.4 mg versus placebo at week 20 (non-significant when corrected for week 20 body weight; P = 0.12). No effect was seen on AUC , maximum observed paracetamol concentration, or time to maximum observed paracetamol concentration. Ad libitum energy intake was 35% lower with semaglutide versus placebo (1736 versus 2676 kJ; estimated treatment difference -940 kJ; P <0.0001). Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety when compared with placebo (all P <0.02). The CoEQ indicated better control of eating and fewer/weaker food cravings with semaglutide versus placebo (P <0.05). Body weight was reduced by 9.9% with semaglutide and 0.4% with placebo. Safety was consistent with the known profile of semaglutide.
In adults with obesity, once-weekly s.c. semaglutide 2.4 mg suppressed appetite, improved control of eating, and reduced food cravings, ad libitum energy intake and body weight versus placebo. There was no evidence of delayed gastric emptying at week 20, assessed indirectly via paracetamol absorption.
研究每周一次皮下注射司美格鲁肽 2.4mg 对肥胖成年人胃排空、食欲和能量摄入的影响。
这是一项在 72 名肥胖成年人中进行的双盲、平行组试验,他们被随机分为每周一次皮下注射司美格鲁肽(剂量递增至 2.4mg)或安慰剂组,治疗 20 周。通过标准化早餐后对扑热息痛的吸收来评估胃排空。评估了参与者报告的食欲评分和饮食控制问卷(CoEQ)的反应,并在自由进食午餐期间测量了能量摄入。
与安慰剂相比,标准化餐食后 0 至 5 小时的扑热息痛浓度-时间曲线下面积(AUC;主要终点)增加了 8%(P=0.005),但在第 20 周时,校正体重后无显著差异(P=0.12)。扑热息痛 AUC、最大观察浓度或最大观察浓度时间无影响。与安慰剂相比,司美格鲁肽组的自由进食能量摄入降低了 35%(1736 与 2676kJ;估计治疗差异-940kJ;P<0.0001)。与安慰剂相比,司美格鲁肽降低了饥饿感和预期食物摄入量,增加了饱腹感和满足感(均 P<0.02)。与安慰剂相比,CoEQ 显示司美格鲁肽在饮食控制方面更好,食物渴望更少/更弱(P<0.05)。与安慰剂相比,司美格鲁肽降低了 9.9%的体重,而安慰剂降低了 0.4%的体重。安全性与司美格鲁肽的已知特征一致。
在肥胖成年人中,每周一次皮下注射司美格鲁肽 2.4mg 可抑制食欲,改善饮食控制,减少食物渴望,与安慰剂相比,自由进食能量摄入和体重降低。在第 20 周时,通过扑热息痛吸收间接评估,没有证据表明胃排空延迟。