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Efficacy and safety of once weekly semaglutide 2·4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial
Abstract
Background Data on the benefits of the once weekly GLP-1 receptor agonist semaglutide 2·4 mg for weight management in people from east Asia are insufficient. The objective of this study was to determine the efficacy and safety of once weekly semaglutide 2·4 mg versus placebo for weight management in a predominantly east Asian adult population. Methods This randomised phase 3a, double-blind multicentre controlled trial (STEP 7) recruited participants from 23 hospitals and trial centres in China, Hong Kong, Brazil, and South Korea. Adults with overweight or obesity, with or without type 2 diabetes, were randomly assigned (2:1) to receive a subcutaneous injection of either semaglutide 2·4 mg or placebo once a week for 44 weeks, plus a diet and physical activity intervention. Randomisation was done in blocks of six with an interactive web response system and was stratified by diagnosis of type 2 diabetes. Participants, investigators, and the trial sponsor were masked to treatment allocation until after database lock. Primary endpoints were percentage change in mean bodyweight and proportion of participants having reached a weight reduction of at least 5% of bodyweight from baseline to week 44. Safety was assessed in all participants who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT04251156, and is now complete. Findings From Dec 8, 2020, to Aug 23, 2022, 448 participants were screened, of whom 375 were randomly assigned to either…
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“Seven of the 10 RCTs were judged to have a low risk of bias based on the RoB 2 tool [5, 6, 13, 14, 26, 28, 29].”
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Metadata
- Authors
- Mu, Y., Bao, X., Eliaschewitz, F. G., Hansen, M. R., Kim, B. T., Koroleva, A., Ma, R. C. W., Yang, T., Zu, N., & Liu, M.
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2024-03
- Volume
- 12
- Issue
- 3
- Pages
- 184-195
- ISSN
- 2213-8587
- Cited by
- 133
- References
- 10
- Language
- en
- Licence
- Funders
- Novo Nordisk (NCT04251156)
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