Table 3.
Adverse events in Patients with T2DM.
| LY3298176 0.5 mg N = 9 |
LY3298176 5 mg N = 9 |
LY3298176 5/5/10/10 mg N = 12 |
LY3298176 5/5/10/15 mg N = 12 |
Placebo N = 11 |
All N = 53 |
|
|---|---|---|---|---|---|---|
| Any TEAE | 5 (55.6) | 7 (77.8) | 10 (83.3) | 11 (91.7) | 3 (27.3) | 36 (67.9) |
| Mild, events | 15 | 17 | 54 | 87 | 6 | 179 |
| Moderate, events | 0 | 0 | 1 | 9 | 0 | 10 |
| Severe, events | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious adverse events | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Study discontinuation due to adverse events | 0 (0.0) | 3 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any TEAEs in order of frequency | ||||||
| Vomiting | 1 (11.1) | 0 (0.0) | 1 (8.3) | 9 (75.0) | 0 (0.0) | 11 (20.8) |
| Decreased appetite | 2 (22.2) | 6 (66.7) | 5 (41.7) | 11 (91.7) | 1 (9.1) | 25 (47.2) |
| Diarrhoea | 1 (11.1) | 1 (11.1) | 3 (25.0) | 5 (41.7) | 1 (9.1) | 11 (20.8) |
| Abdominal distension | 0 (0.0) | 1 (11.1) | 2 (16.7) | 7 (58.3) | 0 (0.0) | 10 (18.9) |
| Nausea | 1 (11.1) | 1 (11.1) | 1 (8.3) | 6 (50.0) | 0 (0.0) | 9 (17.0) |
| Gastrooesophageal reflux disease | 0 (0.0) | 1 (11.1) | 1 (8.3) | 5 (41.7) | 0 (0.0) | 7 (13.2) |
| Eructation | 0 (0.0) | 0 (0.0) | 1 (8.3) | 4 (33.3) | 0 (0.0) | 5 (9.4) |
| Weight decrease | 0 (0.0) | 0 (0.0) | 2 (16.7) | 2 (16.7) | 0 (0.0) | 4 (7.5) |
| Dyspepsia | 0 (0.0) | 0 (0.0) | 3 (25.0) | 0 (0.0) | 0 (0.0) | 3 (5.7) |
| Headache | 1 (11.1) | 0 (0.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) | 3 (5.7) |
| Abdominal pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) | 2 (3.8) |
| Dermatitis allergic | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) | 2 (3.8) |
| Hepatic enzyme increased | 0 (0.0) | 0 (0.0) | 1 (8.3) | 1 (8.3) | 0 (0.0) | 2 (3.8) |
| Pancreatic enzyme increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (8.3) | 1 (9.1) | 2 (3.8) |
| Other adverse events | ||||||
| Total hypoglycaemia (≤70 mg/dL) | 0 (0.0) | 0 (0.0) | 2 (16.7) | 1 (8.3) | 1 (9.1) | 4 (7.5) |
| Severe hypoglycaemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Acute pancreatitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Injection site reaction | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Data presented as n (%), unless otherwise noted. TEAE = treatment-emergent adverse event.