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Table 6 Key information of the STEP 1–5 clinical trials with the GLP-1 receptor agonist semaglutide 2.4 mg

From: Report from the CVOT Summit 2021: new cardiovascular, renal, and glycemic outcomes

Study name Clinicaltrials.gov ID Study status n Participants Intervention Primary outcome Mean body weight at baseline (kg) Mean percentage change in body weight from baseline semaglutide 2.4 mg vs. placebo Percentage of patients who met a weight loss of ≥ 5% with semaglutide 2.4 mg vs. placebo
STEP 1 [43] NCT03548935 Completed 1961 With obesity or overweight, without T2D Semaglutide 2.4 mg once a week vs. placebo Percentage change in body weight and weight reduction of at least 5% at week 68 105.3 − 14.9% vs. − 2.4% 86.4% vs. 31.5%
STEP 2 [44] NCT03552757 Completed 1210 With obesity or overweight, with T2D Semaglutide 2.4 mg once a week vs. semaglutide 1.0 mg and placebo Percentage change in body weight and weight reduction of at least 5% at week 68 99.8 − 9.6% vs. − 3.4% 68.8% vs. 28.5%
STEP 3 [45] NCT03611582 Completed 611 With obesity or overweight, without T2D Semaglutide 2.4 mg once a week vs. placebo in addition to intensive behavioral therapy Percentage change in body weight and weight reduction of at least 5% at week 68 105.8 − 16.0% vs. − 5.7% 86.6% vs. 47.6%
STEP 4 [46] NCT03548987 Completed 902 With obesity or overweight, without T2D Semaglutide 2.4 mg once a week for the first 20 weeks, then random assignment: semaglutide 2.4 mg once a week vs. placebo for 48 weeks Percent change in body weight from week 20 to week 68 107.2 − 7.9% vs. + 6.9% Not applicable
STEP 5 [58] NCT03693430 Completed 304 With obesity or overweight, without T2D Semaglutide 2.4 mg once a week vs. placebo Percentage change in body weight and weight reduction of at least 5% at week 104 106.0 − 15.2% vs. − 2.6% 77.1% vs. 34.4