TY - JOUR
T1 - Semaglutide 2.4 mg for the Treatment of Obesity
T2 - Key Elements of the STEP Trials 1 to 5
AU - Kushner, Robert F.
AU - Calanna, Salvatore
AU - Davies, Melanie
AU - Dicker, Dror
AU - Garvey, W. Timothy
AU - Goldman, Bryan
AU - Lingvay, Ildiko
AU - Thomsen, Mette
AU - Wadden, Thomas A.
AU - Wharton, Sean
AU - Wilding, John P.H.
AU - Rubino, Domenica
N1 - Publisher Copyright:
© 2020 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS)
PY - 2020/6/1
Y1 - 2020/6/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85085156244&partnerID=8YFLogxK
U2 - 10.1002/oby.22794
DO - 10.1002/oby.22794
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C2 - 32441473
AN - SCOPUS:85085156244
SN - 1930-7381
VL - 28
SP - 1050
EP - 1061
JO - Obesity
JF - Obesity
IS - 6
ER -
