@article{977c07bdcca3495c9810c1cd8605d263,
title = "Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5",
abstract = "Objective: The obesity epidemic is a public health concern, warranting further research into pharmacological treatments for weight management (WM) as an adjunct to lifestyle interventions. The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight. Methods: Across five phase 3 trials (NCT03548935, WM; NCT03552757, WM in type 2 diabetes; NCT03611582, WM with intensive behavioral therapy; NCT03548987, sustained WM; and NCT03693430, long-term WM), ~5,000 participants are being randomly assigned to receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results will be available in 2020/2021. For all trials, the primary end point is change from baseline to end of treatment in body weight. Results: Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m2 and a mean waist circumference of 113.0 to 115.7 cm. Conclusions: The STEP program evaluates the efficacy and safety of semaglutide 2.4 mg subcutaneously once weekly in a broad population. The trials will provide insights on WM in people with obesity with and without type 2 diabetes and on long-term follow-up.",
author = "Kushner, {Robert F.} and Salvatore Calanna and Melanie Davies and Dror Dicker and Garvey, {W. Timothy} and Bryan Goldman and Ildiko Lingvay and Mette Thomsen and Wadden, {Thomas A.} and Sean Wharton and Wilding, {John P.H.} and Domenica Rubino",
note = "Funding Information: We acknowledge the trial participants and all personnel involved in these trials. We thank Lisa von Huth Smith for her contribution to the clinical outcome assessment section. This research was supported by the National Institute for Health Research Leicester Biomedical Research Centre. Medical editorial assistance was provided by Anna Bacon and Sara Shaw, PhD, of Articulate Science Ltd. (London, UK). Funding Information: We acknowledge the trial participants and all personnel involved in these trials. We thank Lisa von Huth Smith for her contribution to the clinical outcome assessment section. This research was supported by the National Institute for Health Research Leicester Biomedical Research Centre. Medical editorial assistance was provided by Anna Bacon and Sara Shaw, PhD, of Articulate Science Ltd. (London, UK). Deidentified participant data are available for this article on a specialized SAS data platform (SAS Institute, Cary, NC). Data sets from Novo Nordisk will be available permanently after research completion and approval of product and product use in both the European Union and United States. The study protocol and redacted clinical study report will be available according to Novo Nordisk data-sharing commitments. Access to data can be granted through a request proposal form, and the access criteria can be found online. Data will be shared with bona fide researchers submitting a research proposal requesting access to data. Data use is subject to approval by the independent review board according to the Institutional Review Board Charter (see novonordisk-trials.com). Funding Information: These trials are funded by Novo Nordisk A/S, which also provided financial support for medical editorial assistance. Publisher Copyright: {\textcopyright} 2020 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS)",
year = "2020",
month = jun,
day = "1",
doi = "10.1002/oby.22794",
language = "English (US)",
volume = "28",
pages = "1050--1061",
journal = "Obesity",
issn = "1930-7381",
publisher = "Wiley-Blackwell",
number = "6",
}