POS-336 SEMAGLUTIDE 2.4 MG AND 1.0 MG IMPROVED ALBUMINURIA IN ADULTS WITH OVERWEIGHT/OBESITY AND TYPE 2 DIABETES IN STEP 2

Abstract

This post-hoc exploratory analysis of data from the STEP 2 trial assessed the effect of a higher dose of the glucagon-like peptide-1 analog semaglutide (up to 2.4 mg) vs placebo on albuminuria in adults with overweight or obesity (body mass index ≥27 kg/m2) and type 2 diabetes. Patients were randomized to once-weekly subcutaneous semaglutide 1.0 mg (N=403), 2.4 mg (N=404), or placebo (N=403), plus lifestyle changes for 68 weeks. Albuminuria was assessed using observed on-treatment data. Normal, micro- and macroalbuminuria were defined as urine albumin-to-creatinine ratio (UACR) <30, ≥30–<300, and ≥300 mg/g, respectively. Changes in UACR from baseline (week 0) to week 68 were estimated on the logarithmic scale using a mixed model for repeated measures for the trial product estimand, then transformed back to the original scale. Changes in UACR data are expressed as estimated relative percentage changes within groups and as estimated relative percentage points treatment difference between groups. Proportions of participants with improved UACR status were compared between treatment arms using a Chi-square test. In total, 1189 patients had UACR data at baseline: the observed geometric mean UACR was 13.7, 12.5, and 13.2 mg/g with semaglutide 1.0 mg, 2.4 mg, and placebo, respectively. After 68 weeks, the estimated mean UACR decreased from baseline by 14.8% and 20.6% with semaglutide 1.0 and 2.4 mg, respectively, and increased by 18.3% with placebo (Figure A ). The estimated treatment difference [95% confidence interval] vs placebo was −28.0 %-points [−37.3, −17.3] for semaglutide 1.0 mg (p<0.0001) and −32.9 %-points [−41.6, −23.0] for semaglutide 2.4 mg (p<0.0001). From baseline to week 68, albuminuria prevalence decreased with semaglutide 1.0 and 2.4 mg and increased with placebo (Figure B ). A greater proportion of patients who received semaglutide 1.0 and 2.4 mg had improved UACR status (macro to micro/normal; micro to normal) from baseline to week 68 vs placebo (p=0.0004 and p=0.0014, respectively; Figure C ). In adults with overweight or obesity and type 2 diabetes, both semaglutide 1.0 and 2.4 mg improved UACR status in patients with baseline albuminuria.