85-OR: Semaglutide 2.4 mg Improves Patient Reported Outcome Measures of Physical Functioning in Adults with Overweight/Obesity and Type 2 Diabetes in the STEP 2 Trial

Abstract

An analysis of the STEP 2 trial evaluated the effect of s.c. semaglutide 2.4 mg vs. placebo (PBO) on physical function (PF) in adults with overweight/obesity and type 2 diabetes (T2D). The STEP 2 trial was an RCT in adults with BMI ≥27 kg/m2 and T2D (NCT03552757). Patients were randomized 1:1:1 to 68 weeks’ once-weekly semaglutide 2.4 mg (N=404), 1.0 mg (N=403; data not shown), or PBO (N=403), plus lifestyle changes. Endpoints included change in PF (baseline-week 68) using the SF-36v2® Health Survey acute version (SF-36) and Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT), and achievement of meaningful within-person PF improvements (≥3.7 points [SF‑36]; ≥14.6 points [IWQoL-Lite-CT]). Patients were 51% female, with a mean age of 55 years, body weight 99.8 kg, and BMI 35.7 kg/m2. Body weight change at week 68 with semaglutide 2.4 mg vs. PBO was -9.6% vs. -3.4%. Semaglutide significantly improved PF vs. PBO on SF-36 and IWQoL‑Lite‑CT (Table). SF-36 and IWQoL-Lite-CT PF improvements correlated with weight loss during the trial. Proportions of patients with clinically meaningful PF improvements were greater with semaglutide vs. PBO (Table). In adults with overweight/obesity and T2D, semaglutide 2.4 mg improved PF vs. PBO, and led to greater proportions of patients with clinically meaningful PF changes in SF-36 and IWQoL-Lite-CT. Disclosure S. Wharton: Advisory Panel; Self; Novo Nordisk A/S, Novo Nordisk Canada Inc., Speaker’s Bureau; Self; AstraZeneca, Bausch Health, Canada, Novo Nordisk, Novo Nordisk Canada Inc. H. H. Meincke: Employee; Self; Novo Nordisk A/S. R. F. Kushner: Advisory Panel; Self; Novo Nordisk A/S. T. Kalayci oral: Employee; Self; Novo Nordisk A/S. S. Pedersen: Advisory Panel; Self; AstraZeneca, Bausch and Lomb Incorporated, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Global Services, LLC., Novo Nordisk, Consultant; Self; Abbott, Research Support; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Speaker’s Bureau; Self; Abbott Laboratories, AstraZeneca, Bausch and Lomb Incorporated, Bayer Inc., Boehringer Ingelheim (Canada) Ltd., Dexcom, Inc., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi. D. Rubino: Advisory Panel; Self; Novo Nordisk, Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Speaker’s Bureau; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. D. H. Ryan: Advisory Panel; Self; Alyvent, Naturally Slim, Epitommee,, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Global Services, LLC., Pfizer Inc., Redesign Health, Inc., Sanofi, Consultant; Self; Bausch Health, Canada, Phenomix, Xeno Bioscience, Gila Therapeutics, Scientific Intake, UnitedHealth Group, Other Relationship; Self; Novo Nordisk Inc. N. Zeuthen: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. R. Kolotkin: Consultant; Self; Novo Nordisk, Other Relationship; Self; Rhythm Pharmaceuticals, Inc. Funding Novo Nordisk A/S