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 |