Once-Weekly Semaglutide in Adults with Overweight or Obesity.
By J. Wilding, R. Batterham, S. Calanna, M. Davies, L. V. Van Gaal, I. Lingvay, B. McGowan, J. Rosenstock, Marie T D Tran, T. Wadden and 4 more. New England Journal of Medicine, 2021
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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).
Subfields: Endocrinology, Diabetes and Metabolism, Molecular Biology, Surgery
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Citations in the corpus
- The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021, background): “However, given the clinical trial results in people without type 1 diabetes [260], these agents may have a role for those with type 1 diabetes who have concomitant obesity.”
- Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension (2022, positive): “4 mg (or placebo) and lifestyle intervention in participants who had completed 68 weeks of initial treatment in the randomized, placebo-controlled Semaglutide Treatment Effect in People with obesity (STEP) 1 trial.(16) Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue recently approved by th”
- Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022, neutral): “4% with placebo) seen in the STEP 1 trial in adults with overweight or obesity without diabetes [129].”
- Inflammation and atherosclerosis: signaling pathways and therapeutic intervention (2022, background): “A recent study indicates that semaglutide is associated with persistent, clinically relevant weight loss.(329) The dulaglutide and cardiovascular outcomes in T2DM study showed that dulaglutide reduced the composite cardiovascular outcomes during 5-year period.”