Wilding, John PH 
ORCID: 0000-0003-2839-8404, Batterham, Rachel L, Calanna, Salvatore, Davies, Melanie, Van Gaal, Luc F, Lingvay, Ildiko, McGowan, Barbara M, Rosenstock, Julio, Tran, Marie TD, Wadden, Thomas A et al (show 4 more authors)
(2021)
Once-Weekly Semaglutide in Adults with Overweight or Obesity.
NEW ENGLAND JOURNAL OF MEDICINE, 384 (11).
pp. 989-1002.
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Abstract
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%]).<h4>Conclusions</h4>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).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | STEP 1 Study Group, Humans, Cholelithiasis, Prediabetic State, Obesity, Weight Loss, Diarrhea, Nausea, Lipids, Anti-Obesity Agents, Body Mass Index, Injections, Subcutaneous, Double-Blind Method, Body Composition, Adult, Middle Aged, Female, Male, Glucagon-Like Peptide 1, Glucagon-Like Peptides, Healthy Lifestyle |
| 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: | 22 Apr 2021 09:09 |
| Last Modified: | 20 Feb 2023 22:50 |
| DOI: | 10.1056/NEJMoa2032183 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3120145 |
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