Table 3.
Treatment-emergent adverse events with total incidence ≥2% by preferred term (safety analysis set)
| TEAEs, n (%) | Ecnoglutide | Placebo N = 36 | Total N = 145 | |||
|---|---|---|---|---|---|---|
| 0.4 mg N = 37 | 0.8 mg N = 36 | 1.2 mg N = 36 | Total N = 109 | |||
| Participants with at least one TEAE | 29 (78.4) | 28 (77.8) | 26 (72.2) | 83 (76.1) | 21 (58.3) | 104 (71.7) |
| Diarrhea | 6 (16.2) | 3 (8.3) | 7 (19.4) | 16 (14.7) | 1 (2.8) | 17 (11.7) |
| Nausea | 2 (5.4) | 4 (11.1) | 7 (19.4) | 13 (11.9) | 1 (2.8) | 14 (9.7) |
| Upper respiratory tract infection | 1 (2.7) | 4 (11.1) | 2 (5.6) | 7 (6.4) | 4 (11.1) | 11 (7.6) |
| Hyperlipidemia | 5 (13.5) | 0 | 4 (11.1) | 9 (8.3) | 2 (5.6) | 11 (7.6) |
| Constipation | 2 (5.4) | 3 (8.3) | 3 (8.3) | 8 (7.3) | 2 (5.6) | 10 (6.9) |
| Proteinuria | 2 (5.4) | 3 (8.3) | 3 (8.3) | 8 (7.3) | 0 | 8 (5.5) |
| Decreased appetite | 2 (5.4) | 2 (5.6) | 3 (8.3) | 7 (6.4) | 0 | 7 (4.8) |
| Hypoglycemia | 1 (2.7) | 4 (11.1) | 1 (2.8) | 6 (5.5) | 1 (2.8) | 7 (4.8) |
| Elevated amylase | 3 (8.1) | 1 (2.8) | 1 (2.8) | 5 (4.6) | 1 (2.8) | 6 (4.1) |
| Elevated lipase | 2 (5.4) | 3 (8.3) | 1 (2.8) | 6 (5.5) | 0 | 6 (4.1) |
| Urinary tract infection | 2 (5.4) | 1 (2.8) | 1 (2.8) | 4 (3.7) | 2 (5.6) | 6 (4.1) |
| Dyslipidemia | 2 (5.4) | 2 (5.6) | 0 | 4 (3.7) | 1 (2.8) | 5 (3.4) |
| GERD | 2 (5.4) | 1 (2.8) | 1 (2.8) | 4 (3.7) | 0 | 4 (2.8) |
| Hyperuricemia | 2 (5.4) | 0 | 0 | 2 (1.8) | 2 (5.6) | 4 (2.8) |
| WBC in urine | 2 (5.4) | 0 | 2 (5.6) | 4 (3.7) | 0 | 4 (2.8) |
| Palpitations | 2 (5.4) | 0 | 1 (2.8) | 3 (2.8) | 1 (2.8) | 4 (2.8) |
| Headache | 0 | 1 (2.8) | 2 (5.6) | 3 (2.8) | 1 (2.8) | 4 (2.8) |
| Dizziness | 0 | 0 | 2 (5.6) | 2 (1.8) | 2 (5.6) | 4 (2.8) |
| Toothache | 2 (5.4) | 0 | 1 (2.8) | 3 (2.8) | 0 | 3 (2.1) |
| Flatulence | 1 (2.7) | 2 (5.6) | 0 | 3 (2.8) | 0 | 3 (2.1) |
| Vomiting | 1 (2.7) | 0 | 2 (5.6) | 3 (2.8) | 0 | 3 (2.1) |
| Hyperhomocysteinemia | 1 (2.7) | 1 (2.8) | 1 (2.8) | 3 (2.8) | 0 | 3 (2.1) |
| Myocardial ischemia | 1 (2.7) | 1 (2.8) | 0 | 2 (1.8) | 1 (2.8) | 3 (2.1) |
| Diabetic nephropathy | 2 (5.4) | 0 | 1 (2.8) | 3 (2.8) | 0 | 3 (2.1) |
| Hypertension | 2 (5.4) | 0 | 0 | 2 (1.8) | 1 (2.8) | 3 (2.1) |
| Insomnia | 0 | 0 | 1 (2.8) | 1 (0.9) | 2 (5.6) | 3 (2.1) |
GERD gastroesophageal reflux disease, TEAE treatment-emergent adverse events, WBC white blood cells.