Wilding, John PH 
ORCID: 0000-0003-2839-8404, Batterham, Rachel L, Davies, Melanie, Van Gaal, Luc F, Kandler, Kristian, Konakli, Katerina, Lingvay, Ildiko, McGowan, Barbara M, Oral, Tugce Kalayci, Rosenstock, Julio et al (show 4 more authors)
(2022)
Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension.
DIABETES OBESITY & METABOLISM, 24 (8).
pp. 1553-1564.
Abstract
<h4>Aim</h4>To explore changes in body weight and cardiometabolic risk factors after treatment withdrawal in the STEP 1 trial extension.<h4>Materials and methods</h4>STEP 1 (NCT03548935) randomized 1961 adults with a body mass index ≥ 30 kg/m<sup>2</sup> (or ≥ 27 kg/m<sup>2</sup> with ≥ 1 weight-related co-morbidity) without diabetes to 68 weeks of once-weekly subcutaneous semaglutide 2.4 mg (including 16 weeks of dose escalation) or placebo, as an adjunct to lifestyle intervention. At week 68, treatments (including lifestyle intervention) were discontinued. An off-treatment extension assessed for a further year a representative subset of participants who had completed 68 weeks of treatment. This subset comprised all eligible participants from any site in Canada, Germany and the UK, and sites in the United States and Japan with the highest main phase recruitment. All analyses in the extension were exploratory.<h4>Results</h4>Extension analyses included 327 participants. From week 0 to week 68, mean weight loss was 17.3% (SD: 9.3%) with semaglutide and 2.0% (SD: 6.1%) with placebo. Following treatment withdrawal, semaglutide and placebo participants regained 11.6 (SD: 7.7) and 1.9 (SD: 4.8) percentage points of lost weight, respectively, by week 120, resulting in net losses of 5.6% (SD: 8.9%) and 0.1% (SD: 5.8%), respectively, from week 0 to week 120. Cardiometabolic improvements seen from week 0 to week 68 with semaglutide reverted towards baseline at week 120 for most variables.<h4>Conclusions</h4>One year after withdrawal of once-weekly subcutaneous semaglutide 2.4 mg and lifestyle intervention, participants regained two-thirds of their prior weight loss, with similar changes in cardiometabolic variables. Findings confirm the chronicity of obesity and suggest ongoing treatment is required to maintain improvements in weight and health.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | antiobesity drug, clinical trial, GLP-1 analogue, obesity therapy, phase III study, weight control |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 13 May 2022 15:24 |
| Last Modified: | 18 Jan 2023 21:03 |
| DOI: | 10.1111/dom.14725 |
| Open Access URL: | https://dom-pubs.onlinelibrary.wiley.com/doi/10.11... |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3154777 |
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