Table 4.
Adverse events in the SURPASS and SURMOUNT-1 studies
| Trial | Treatment arm | Any AEs (%) | SAEs (%) | AEs leading to trial product discontinuation (%) | Acute pancreatitis (%) | Cholelithiasis (%) | Hypoglycemia (< 54 mg/dL) (%) | Diarrhea (%) | Nausea (%) | Vomiting (%) | Constipation (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| SURPASS-1 | Tirzepatide 5 mg (n = 121) | 69 | 4 | 3 | 0 | 1 | 0 | 12 | 12 | 3 | 6 |
| Tirzepatide 10 mg (n = 121) | 67 | 2 | 5 | 0 | 0 | 0 | 14 | 13 | 2 | 5 | |
| Tirzepatide 15 mg (n = 121) | 64 | 1 | 7 | 0 | 0 | 0 | 12 | 18 | 6 | 7 | |
| Placebo (n = 115) | 66 | 3 | 3 | 0 | 0 | 1 | 8 | 6 | 2 | 1 | |
| SURPASS-2 | Tirzepatide 5 mg (n = 470) | 64 | 7 | 5 | 0 | 0.2 | 0.6 | 13 | 17 | 6 | 7 |
| Tirzepatide 10 mg (n = 469) | 69 | 5 | 8 | 0.4 | 0.4 | 0.2 | 16 | 19 | 9 | 5 | |
| Tirzepatide 15 mg (n = 470) | 69 | 6 | 8 | 0.4 | 0.4 | 2 | 14 | 22 | 10 | 5 | |
| Semaglutide 1 mg (n = 469) | 64 | 3 | 4 | 0.6 | 0 | 0.4 | 12 | 18 | 8 | 6 | |
| SURPASS-3 | Tirzepatide 5 mg (n = 358) | 61 | 8 | 7 | 0 | 1 | 1 | 15 | 12 | 6 | NR |
| Tirzepatide 10 mg (n = 360) | 69 | 6 | 10 | 0 | <1 | 1 | 17 | 23 | 9 | NR | |
| Tirzepatide 15 mg (n = 359) | 73 | 7 | 11 | 0 | <1 | 2 | 16 | 24 | 10 | NR | |
| Insulin degludec (n = 360) | 54 | 6 | 1 | 0 | 0 | 7 | 4 | 2 | 1 | NR | |
| SURPASS-4 | Tirzepatide 5 mg (n = 329) | 71 | 15 | 11 | <1 | <1 | 9 | 13 | 12 | 5 | 5 |
| Tirzepatide 10 mg (n = 328) | 74 | 17 | 9 | <1 | <1 | 6 | 20 | 16 | 8 | 4 | |
| Tirzepatide 15 mg (n = 338) | 77 | 12 | 11 | <1 | <1 | 8 | 22 | 23 | 9 | 4 | |
| Insulin lantus (n = 1,000) | 68 | 19 | 5 | <1 | <1 | 19 | 4 | 2 | 2 | <1 | |
| SURPASS-5 | Tirzepatide 5 mg (n = 116) | 73 | 8 | 6 | 0 | 0.9 | 16 | 12 | 13 | 7 | 6 |
| Tirzepatide 10 mg (n = 119) | 68 | 11 | 8 | 0 | 0 | 19 | 13 | 18 | 8 | 7 | |
| Tirzepatide 15 mg (n = 120) | 78 | 8 | 11 | 0 | 0 | 14 | 21 | 18 | 13 | 7 | |
| Placebo (n = 120) | 68 | 8 | 3 | 0 | 0 | 13 | 10 | 3 | 3 | 2 | |
| SURPASS J-mono | Tirzepatide 5 mg (n = 159) | 82 | 5 | 8 | 0 | 1 | 0 | 17 | 12 | 8 | 15 |
| Tirzepatide 10 mg (n = 158) | 77 | 6 | 10 | 0 | 0 | 0 | 9 | 20 | 5 | 18 | |
| Tirzepatide 15 mg (n = 160) | 84 | 4 | 10 | 1 | 1 | 1 | 11 | 20 | 12 | 14 | |
| Dulaglutide 0.75 mg (n = 159) | 77 | 9 | 6 | 0 | 0 | 0 | 7 | 8 | 1 | 11 | |
| SURPASS J-combo | Tirzepatide 5 mg (n = 148) | 74 | 1 | 5 | 0 | 1 | 1 | 7 | 9 | 3 | 8 |
| Tirzepatide 10 mg (n = 147) | 74 | 7 | 5 | 0 | 1 | 1 | 14 | 14 | 7 | 14 | |
| Tirzepatide 15 mg (n = 148) | 84 | 7 | 11 | 0 | 1 | 2 | 14 | 27 | 10 | 15 | |
| SURMOUNT-1 | Tirzepatide 5 mg (n = 630) | 81 | 6 | 1 | 0.2 | 1 | 1 | 19 | 25 | 8 | 17 |
| Tirzepatide 10 mg (n = 636) | 82 | 7 | 3 | 0.2 | 1 | 2 | 21 | 33 | 11 | 17 | |
| Tirzepatide 15 mg (n = 630) | 79 | 5 | 3 | 0.2 | 0.6 | 2 | 23 | 31 | 12 | 12 | |
| Placebo (n = 643) | 72 | 7 | <1 | 0.2 | 0.9 | 0.2 | 7 | 10 | 2 | 6 |
AE, adverse event; SAE, serious adverse event; NR, not reported.