Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity

• DOI: 10.1001/jama.2021.3224
• Publication Date: 2021-03-23T18:30:26Z
• Authors: Domenica Rubino; Niclas Abrahamsson; Melanie Davies; Dan Hesse; Frank L. Greenway; Camilla Jensen; Ildiko Lingvay; Ofri Mosenzon; Julio Rosenstock; Miguel A. Rubio; Gottfried Rudofsky; Sayeh Tadayon; Thomas A. Wadden; Dror Dicker; ; Mette Friberg; Anders Sjödin; Dror Dicker; Gabriella Segal; Ofri Mosenzon; Muhammad Sabbah; Yael Sofer; Victor Vishlitzky; Eelco W. Meesters; Mirelle Serlie; Arianne van Bon; Helena Cardoso; Paula Freitas; Pedro Carneiro de...; Margarida Monteiro; Mariana Monteiro; Dírcea Rodrigues; Aysha Badat; Pankaj Joshi; Gulam Latiff; Essack A. Mitha; Hans H. Snyman; Elane van Nieuwen...; Olga González Alb...; Assumpta Caixas; Carmen de al Cuesta; Pedro Pablo Garci...; Cristobal Morales...; Pedro Mezquita Raya; Miguel Angel Rubio; Niclas Abrahamsson; Johan Hoffstedt; Fredrik von Wowern; Erik Uddman; Birgit Bach-Kliegel; Felix Beuschlein; Stefan Bilz; Alain Golay; Gottfried Rudofsky; Christopher Strey; Galyna Fadieienko; Nataliia Kosei; Tetiana Tatarchuk; Valentyna Velychko; Olesya Zinych; Stephen L. Aronoff; Harold E. Bays; Andrew P. Brockmyre; Robert S. Call; Charles Crump; Cyrus V. Desouza; Valerie Espinosa; Almena L. Free; Winston H. Gandy; Steven A. Geller; Gregory M. Gottsc...; Frank L. Greenway; Laurie Han-Conrad; Wayne Harper; Lee Herman; Mitzie Hewitt; Priscilla Hollander; Steven R. Kaster; Anastasios Manessis; Frederick A. Martin; Robert E. McNeill; Alexander V. Murray; Paul C. Norwood; John C.H. Reed; Julio Rosenstock; Domenica M. Rubino; Martin J. Schear; Mark L. Warren
• Keywords: Semaglutide; Subcutaneous injection

The effect of continuing vs withdrawing treatment with semaglutide, a glucagon-like peptide 1 receptor agonist, on weight loss maintenance in people overweight or obesity is unknown.To compare continued once-weekly subcutaneous 2.4 mg, switch to placebo for (both lifestyle intervention) adults after 20-week run-in semaglutide titrated mg weekly.Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites 10 countries from June 2018 March 2020 body mass index least 30 (or ≥27 ≥1 weight-related comorbidity) and without diabetes.A total 902 participants received during run-in. After 20 weeks (16 dose escalation; 4 dose), 803 (89.0%) who reached the 2.4-mg/wk were randomized (2:1) 48 (n = 535) switched 268), plus intervention both groups.The primary end point was percent change week 68; confirmatory secondary points changes waist circumference, systolic blood pressure, physical functioning (assessed using Short Form 36 Version 2 Health Survey, Acute [SF-36]).Among completed period (with mean 10.6%) (mean age, 46 [SD, 12] years; 634 [79%] women; weight, 107.2 kg 22.7 kg]), 787 (98.0%) trial 741 (92.3%) treatment. With 68 -7.9% +6.9% (difference, -14.8 [95% CI, -16.0 -13.5] percentage points; P < .001). Waist circumference (-9.7 cm -10.9 -8.5 cm]), pressure (-3.9 mm Hg -5.8 -2.0 Hg]), SF-36 score (2.5 1.6-3.3]) also improved (all Gastrointestinal events reported 49.1% 26.1% placebo; similar proportions discontinued because adverse (2.4%) (2.2%).Among once weekly, maintaining compared switching resulted over following weeks.ClinicalTrials.gov Identifier: NCT03548987.