干旱区生态环境知识资源中心(Arid): Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial

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DOI	10.1016/S0140-6736(23)01185-6
	Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial
	Knop, Filip K.; Aroda, Vanita R.; do Vale, Ruben D.; Holst-Hansen, Thomas; Laursen, Peter N.; Rosenstock, Julio; Rubino, Domenica M.; Garvey, W. Timothy
通讯作者	Knop, FK
来源期刊	LANCET
ISSN	0140-6736
EISSN	1474-547X
出版年	2023
卷号	402 期号:10403 页码:705-719
英文摘要	Background We assessed the efficacy and safety of the oral glucagon-like peptide-1 analogue, semaglutide 50 mg, taken once per day versus placebo for the treatment of overweight or obesity in adults without type 2 diabetes. Methods This randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m(2), or at least 27 kg/m(2) with bodyweight-related complications and comorbidities, without type 2 diabetes. The trial was done at 50 outpatient clinics in nine countries across Asia, Europe, and North America. Participants were randomly allocated (1:1) via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once per day for 68 weeks, plus lifestyle intervention. Group assignment was masked for participants, investigators, and those assessing outcomes. Coprimary endpoints were the percentage change in bodyweight and whether participants reached a bodyweight reduction of at least 5% at week 68 for oral semaglutide 50 mg versus placebo, assessed regardless of treatment discontinuation or use of other bodyweight-lowering therapies (an intention-to-treat analysis). Safety was assessed in participants who received at least one dose of trial drug. This trial, registered with ClinicalTrials.gov (NCT05035095), is now complete. Findings From Sept 13 to Nov 22, 2021, 709 participants were screened, of whom 667 were randomly assigned to oral semaglutide 50 mg (n=334) or placebo (n=333). The estimated mean bodyweight change from baseline to week 68 was -15 center dot 1% (SE 0 center dot 5) with oral semaglutide 50 mg versus -2 center dot 4% (0 center dot 5) with placebo (estimated treatment difference -12 center dot 7 percentage points, 95% CI -14 center dot 2 to -11 center dot 3; p<0 center dot 0001). More participants reached bodyweight reductions of at least 5% (269 [85%] of 317 vs 76 [26%] of 295; odds ratio [OR] 12 center dot 6, 95% CI 8 center dot 5 to 18 center dot 7; p<0 center dot 0001), 10% (220 [69%] vs 35 [12%]; OR 14 center dot 7, 9 center dot 6 to 22 center dot 6), 15% (170 [54%] vs 17 [6%]; OR 17 center dot 9, 10 center dot 4 to 30 center dot 7), and 20% (107 [34%] vs 8 [3%]; OR 18 center dot 5, 8 center dot 8 to 38 center dot 9) at week 68 with oral semaglutide 50 mg versus placebo. Adverse events were more frequent with oral semaglutide 50 mg (307 [92%] of 334) than with placebo (285 [86%] of 333). Gastrointestinal adverse events (mostly mild to moderate) were reported in 268 (80%) participants with oral semaglutide 50 mg and 154 (46%) with placebo. Interpretation In adults with overweight or obesity without type 2 diabetes, oral semaglutide 50 mg once per day led to a superior and clinically meaningful decrease in bodyweight compared with placebo. Funding Novo Nordisk. Copyright (c) 2023 Elsevier Ltd. All rights reserved.
类型	Article
语种	英语
收录类别	SCI-E
WOS记录号	WOS:001070196500001
WOS关键词	WEIGHT-LOSS ; ASSOCIATION
WOS类目	Medicine, General & Internal
WOS研究方向	General & Internal Medicine
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/397621
推荐引用方式 GB/T 7714	Knop, Filip K.,Aroda, Vanita R.,do Vale, Ruben D.,et al. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial[J],2023,402(10403):705-719.
APA	Knop, Filip K..,Aroda, Vanita R..,do Vale, Ruben D..,Holst-Hansen, Thomas.,Laursen, Peter N..,...&Garvey, W. Timothy.(2023).Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial.LANCET,402(10403),705-719.
MLA	Knop, Filip K.,et al."Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial".LANCET 402.10403(2023):705-719.