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John P.H. Wilding, Rachel Louise Batterham, Salvatore Calanna, Melanie Jane Davies, Luc F. Van Gaal, Ildiko Lingvay, Barbara M. McGowan, Julio Rosenstock, Marie Thi Dao Tran, Thomas A. Wadden and 4 more
BACKGROUND: Obesity is a global health challenge with few pharmacologic options. Whether adults with obesity can achieve weight loss with once-weekly semaglutide at a dose of 2.4 mg as an adjunct to lifestyle intervention has not been confirmed. METHODS: In this double-blind trial, we enrolled 1961 adults with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or greater (≥27 in persons with ≥1 weight-related coexisting condition), who did not have diabetes, and randomly assigned them, in a 2:1 ratio, to 68 weeks of treatment with once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo, plus lifestyle intervention. The coprimary end points were the percentage change in body weight and weight reduction of at least 5%. The primary estimand (a precise description of the treatment effect reflecting the objective of the clinical trial) assessed effects regardless of treatment discontinuation or rescue interventions. RESULTS: The mean change in body weight from baseline to week 68 was -14.9% in the semaglutide group as compared with -2.4% with placebo, for an estimated treatment difference of -12.4 percentage points (95% confidence interval [CI], -13.4 to -11.5; P<0.001). More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (1047 participants [86.4%] vs. 182 [31.5%]), 10% or more (838 [69.1%] vs. 69 [12.0%]), and 15% or more (612 [50.5%] vs. 28 [4.9%]) at week 68 (P<0.001 for all three comparisons of odds). The change in body weight from baseline to week 68 was -15.3 kg in the semaglutide group as compared with -2.6 kg in the placebo group (estimated treatment difference, -12.7 kg; 95% CI, -13.7 to -11.7). Participants who received semaglutide had a greater improvement with respect to cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo. Nausea and diarrhea were the most common adverse events with semaglutide; they were typically transient and mild-to-moderate in severity and subsided with time. More participants in the semaglutide group than in the placebo group discontinued treatment owing to gastrointestinal events (59 [4.5%] vs. 5 [0.8%]). CONCLUSIONS: In participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight. (Funded by Novo Nordisk; STEP 1 ClinicalTrials.gov number, NCT03548935).
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Wilding, J. P., Batterham, R. L., Calanna, S., Davies, M. J., Gaal, L. F. V., Lingvay, I., McGowan, B. M., Rosenstock, J., Tran, M. T. D., Wadden, T. A., Wharton, S., Yokote, K., Zeuthen, N., & Kushner, R. F. (2021). Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine, 384(11), 989–1002. https://doi.org/10.1056/nejmoa2032183
Wilding, John P.H., et al. "Once-Weekly Semaglutide in Adults with Overweight or Obesity." New England Journal of Medicine, vol. 384, no. 11, 2021, pp. 989–1002, https://doi.org/10.1056/nejmoa2032183.
Wilding, John P.H., Rachel Louise Batterham, Salvatore Calanna, Melanie Jane Davies, Luc F. Van Gaal, Ildiko Lingvay, Barbara M. McGowan, et al. "Once-Weekly Semaglutide in Adults with Overweight or Obesity." New England Journal of Medicine 384, no. 11 (2021): 989–1002. https://doi.org/10.1056/nejmoa2032183.
Wilding J. P., Batterham R. L., Calanna S. [и др.] Once-Weekly Semaglutide in Adults with Overweight or Obesity // New England Journal of Medicine. — 2021. — Vol. 384, № 11. — P. 989–1002. — URL: https://doi.org/10.1056/nejmoa2032183
@article{wilding2021onceweekly,
title = {{Once-Weekly Semaglutide in Adults with Overweight or Obesity}},
author = {John P.H. Wilding and Rachel Louise Batterham and Salvatore Calanna and Melanie Jane Davies and Luc F. Van Gaal and Ildiko Lingvay and Barbara M. McGowan and Julio Rosenstock and Marie Thi Dao Tran and Thomas A. Wadden and Sean Wharton and Koutaro Yokote and Niels Zeuthen and Robert F. Kushner},
journal = {New England Journal of Medicine},
year = {2021},
volume = {384},
number = {11},
pages = {989--1002},
doi = {10.1056/nejmoa2032183},
url = {https://doi.org/10.1056/nejmoa2032183}
}TY - JOUR AU - Wilding, John P.H. AU - Batterham, Rachel Louise AU - Calanna, Salvatore AU - Davies, Melanie Jane AU - Gaal, Luc F. Van AU - Lingvay, Ildiko AU - McGowan, Barbara M. AU - Rosenstock, Julio AU - Tran, Marie Thi Dao AU - Wadden, Thomas A. AU - Wharton, Sean AU - Yokote, Koutaro AU - Zeuthen, Niels AU - Kushner, Robert F. TI - Once-Weekly Semaglutide in Adults with Overweight or Obesity JO - New England Journal of Medicine VL - 384 IS - 11 SP - 989 EP - 1002 PY - 2021 DA - 2021/02/10 DO - 10.1056/nejmoa2032183 UR - https://doi.org/10.1056/nejmoa2032183 ER -
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