Table 3.
Selected safety assessments (safety set)
| Placebo n = 60 | Efpeglenatide 4 mg once weekly n = 59 | Efpeglenatide 6 mg once weekly n = 59 | Efpeglenatide 6 mg once every 2 wk n = 59 | Efpeglenatide 8 mg once every 2 wk n = 58 | |
|---|---|---|---|---|---|
| Any TEAEa | 48 (80.0) | 51 (86.4) | 54 (91.5) | 51 (86.4) | 51 (87.9) |
| GI disorders | 28 (46.7) | 43 (72.9) | 49 (83.1) | 38 (64.4) | 44 (75.9) |
| Nausea | 11 (18.3) | 32 (54.2) | 35 (59.3) | 28 (47.5) | 36 (62.1) |
| Vomiting | 4 (6.7) | 13 (22.0) | 13 (22.0) | 10 (16.9) | 19 (32.8) |
| Diarrhoea | 12 (20.0) | 14 (23.7) | 12 (20.3) | 15 (25.4) | 16 (27.6) |
| Dyspepsia | 2 (3.3) | 12 (20.3) | 16 (27.1) | 9 (15.3) | 15 (25.9) |
| Constipation | 5 (8.3) | 10 (16.9) | 12 (20.3) | 9 (15.3) | 12 (20.7) |
| Severe GI‐related TEAEs | 0 | 2 (3.4) | 2 (3.4) | 1 (1.7) | 3 (5.2) |
| Vomiting | 0 | 2 (3.4) | 1 (1.7) | 0 | 2 (3.4) |
| Upper abdominal pain | 0 | 1 (1.7) | 1 (1.7) | 1 (1.7) | 1 (1.7) |
| Nausea | 0 | 1 (1.7) | 1 (1.7) | 0 | 2 (3.4) |
| Diarrhoea | 0 | 0 | 0 | 0 | 1 (1.7) |
| Dyspepsia | 0 | 0 | 0 | 0 | 1 (1.7) |
| Symptomatic hypoglycaemia | 0 | 0 | 1 (1.7) | 0 | 1 (1.7) |
| Injection‐site reaction | 13 (21.7) | 11 (18.6) | 7 (11.9) | 5 (8.5) | 8 (13.8) |
| Serious TEAEs | 0 (0) | 1 (1.7) | 3 (5.1) | 0 (0) | 2 (3.4) |
| Any TEAE leading to discontinuation | 4 (6.7) | 3 (5.1) | 11 (18.6) | 7 (11.9) | 10 (17.2) |
Data are n (%).
An adverse event was considered treatment‐emergent if it had a start date or increased in severity on or after the first dose of study drug.
Abbreviations: GI, gastrointestinal; TEAE, treatment‐emergent adverse event.
a
More than one event could be reported in a single participant.