Table 3.
Selected safety assessments (safety set)
| Placeboa (n = 50) | Efpeglenatide 8 mg (n = 52) | Efpeglenatide 12 mg (n = 52) | Efpeglenatide 16 mg (n = 53) | Efpeglenatide overallb (n = 157) | |
|---|---|---|---|---|---|
| Any TEAE | 32 (64.0) | 43 (82.7) | 43 (82.7) | 43 (81.1) | 129 (82.2) |
| GI disorders | 10 (20.0) | 26 (50.0) | 29 (55.8) | 31 (58.5) | 86 (54.8) |
| Nausea | 1 (2.0) | 14 (26.9) | 24 (46.2) | 23 (43.4) | 61 (38.9) |
| Vomiting | 2 (4.0) | 8 (15.4) | 13 (25.0) | 17 (32.1) | 38 (24.2) |
| Diarrhoea | 4 (8.0) | 9 (17.3) | 8 (15.4) | 11 (20.8) | 28 (17.8) |
| Injection‐site reaction | 2 (4.0) | 4 (7.7) | 4 (7.7) | 2 (3.8) | 10 (6.4) |
| Antibody formation | |||||
| Baseline | 2 (4.0) | 5 (9.6) | 4 (7.7) | 7 (13.2) | 16 (10.2) |
| Treatment‐emergent (any titre)c | 1 (2.0) | 6 (11.5) | 8 (15.4) | 6 (11.3) | 20 (12.7) |
| Treatment‐emergent (titre ≥2)d | 1 (2.0) | 5 (9.6) | 6 (11.5) | 4 (7.5) | 15 (9.6) |
| Any TEAE leading to discontinuation | 1 (2.0) | 6 (11.5) | 7 (13.5) | 8 (15.1) | 21 (13.4) |
| SAEs | |||||
| Any | 2 (4.0) | 0 (0.0) | 5 (9.6) | 3 (5.7) | 8 (5.1) |
| GI disorders | 1 (2.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) | 1 (0.6) |
| Injury, poisoning and procedural complications | 1 (2.0) | 0 (0.0) | 1 (1.9) | 1 (1.9) | 2 (1.3) |
| Neoplasms: benign, malignant and unspecified | 0 (0.0) | 0 (0.0) | 1 (1.9) | 1 (1.9) | 2 (1.3) |
| Nervous system disorders | 0 (0.0) | 0 (0.0) | 1 (1.9) | 1 (1.9) | 2 (1.3) |
| Psychiatric disorders | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) | 1 (0.6) |
| Self‐reported hypoglycaemic episodese | 2 (4.0) | 5 (9.6) | 7 (13.5) | 10 (18.9) | 22 (14.0) |
Note: Data are n (%).
Abbreviations: ADA, antidrug antibody; GI, gastrointestinal; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.
Ten patients were missing one or more post‐baseline measurement.
One patient did not have a baseline measurement; 35 patients were missing one or more post‐baseline measurement.
Overall incidence of treatment‐induced ADAs (with any titre) and treatment‐boosted ADAs (log 2‐expressed titre of pre‐existing ADA level boosted by at least 2).
Overall incidence of treatment‐induced ADAs (with log 2‐expressed titre of at least 2) and treatment‐boosted ADAs (log 2‐expressed titre of pre‐existing ADA level boosted by at least 2).
Patients who experienced any self‐reported hypoglycaemic episodes based on hypoglycaemic feelings between study day 1 and 155 (follow‐up visit).