Summary of STEP safety outcomes11–15
| Trial (n) | Doses and comparators | Duration in weeks | AE (%) | GI AE (%) | Discontinuation due to GI AE (%) | Severe or BG-confirmed hypoglycemia |
| STEP 1 (n=1961)11 | SC semaglutide 2.4 mg Placebo | 68 | 86.7 86.4 | 74.2 47.9 | 4.5 0.8 | 0.6 0.8 |
| STEP 2 (n=1210)12 | SC semaglutide 2.4 mg SC semaglutide 1.0 mg Placebo | 68 | 97.6 81.8 76.9 | 63.5 57.5 34.3 | 4.2 3.5 1.0 | 5.7 5.5 3.0 |
| STEP 3 (n=611)13 | SC semaglutide 2.4 mg Placebo (+intensive behavioral therapy) | 68 | 95.8 96.1 | 82.8 63.2 | 3.4 0 | 0.5 0 |
| STEP 4 (n=902)14 | SC semaglutide (68 total weeks) SC semaglutide (20 weeks), then Placebo (48 weeks) | 68 | 81.3 75 | 49.1 26.1 | 2.4 2.2 | 0.6 1.1 |
| STEP 5 (n=304)15 | SC semaglutide 2.4 mg Placebo | Results Pending | Results Pending | Results Pending | Results Pending |
Results for STEP 515 are pending at the time of writing this review.
AE, adverse events; BG, blood glucose; GI, gastrointestinal; SC, subcutaneous; STEP, Semaglutide Treatment Effect in People with Obesity.