Table 2.
Summary of treatment‐emergent adverse events (AEs)
| Preferred term | Placebo (N = 26) n (%) | TZP 12 mg (N = 29) n (%) | TZP 15 mg‐1 (N = 28) n (%) | TZP 15 mg‐2 (N = 28) n (%) |
|---|---|---|---|---|
| Deaths | 0 | 0 | 0 | 0 |
| Serious AEs | 0 | 1 (3.4) | 0 | 0 |
| Treatment‐emergent AEs | 13 (50.0) | 23 (79.3) | 19 (67.9) | 24 (85.7) |
| Discontinuations from study because of AEs | 0 | 0 | 0 | 0 |
| Discontinuation of study treatment drug because of AEs | 1 (3.8) | 1 (3.4) | 1 (3.6) | 0 |
| Patients with ≥1 treatment‐emergent AEs | ||||
| Mild | 8 (30.8) | 17 (58.6) | 12 (42.9) | 14 (50.0) |
| Moderate | 5 (19.2) | 6 (20.7) | 7 (25.0) | 9 (32.1) |
| Severe | 0 | 0 | 0 | 1 (3.6) |
| Treatment‐emergent AEs occurring in at least 5% of patients | ||||
| Nausea | 2 (7.7) | 7 (24.1) | 11 (39.3) | 10 (35.7) |
| Diarrhoea | 2 (7.7) | 9 (31.0) | 10 (35.7) | 9 (32.1) |
| Decreased appetite | 0 | 4 (13.8) | 6 (21.4) | 8 (28.6) |
| Vomiting | 1 (3.8) | 5 (17.2) | 5 (17.9) | 5 (17.9) |
| Headache | 2 (7.7) | 2 (6.9) | 6 (21.4) | 5 (17.9) |
| Dyspepsia | 0 | 5 (17.2) | 3 (10.7) | 3 (10.7) |
| Constipation | 0 | 1 (3.4) | 3 (10.7) | 5 (17.9) |
| Abdominal pain | 1 (3.8) | 1 (3.4) | 5 (17.9) | 1 (3.6) |
| Dizziness | 2 (7.7) | 0 | 1 (3.6) | 3 (10.7) |
| Other treatment‐emergent AEs | ||||
| Hypoglycaemia (plasma glucose ≤70 mg/dL) | 0 | 2 (6.9) | 5 (17.9) | 5 (17.9) |
| Hypoglycaemia (plasma glucose ≤54 mg/dL) | 0 | 0 | 0 | 0* |
| Severe hypoglycaemia | 0 | 0 | 0 | 0 |
| Cholecystitis | 0 | 0 | 0 | 0 |
| Acute pancreatitis | 0 | 0 | 0 | 0 |
| Injection site reaction | 0 | 2 (6.9) | 2 (7.1) | 0 |
| Hypersensitivity | 1 (3.8) | 0 | 0 | 0 |
Abbreviations: N, number of subjects in the analysis population; n, number of subjects with AEs; TZP, tirzepatide.
*
It cannot be ruled out that one patient had a hypoglycaemia event of plasma glucose ≤54 mg/dL because this patient reported hypoglycaemia but did not record a plasma glucose value.