Table 1.
Baseline characteristics
| Somapacitan (0.04 mg/kg/wk) | Somapacitan (0.08 mg/kg/wk) | Somapacitan (0.16 mg/kg/wk) | Daily GH (0.034 mg/kg/d) | |
|---|---|---|---|---|
| FAS, n | 14 | 15 | 14 | 14 |
| Male, % | 50.0 | 66.7 | 57.1 | 64.3 |
| Age, y | 5.8 (1.8) | 5.9 (1.8) | 6.1 (2.3) | 6.0 (2.0) |
| Weight, kg | 14.2 (4.22) | 14.0 (3.54) | 14.9 (5.23) | 15.5 (5.03) |
| BMI, kg/m2 | 15.3 (1.1) | 14.6 (1.1) | 15.1 (1.2) | 15.6 (1.4) |
| Height, cm | 95.4 (14.0) | 97.2 (11.3) | 97.7 (16.4) | 98.4 (13.8) |
| Height SDS | −4.1 (1.9) | −3.5 (1.5) | −3.8 (2.0) | −3.4 (1.1) |
| HV SDS | −2.9 (1.9) | −1.8 (1.7) | −2.9 (1.8) | −3.1 (2.1) |
| Bone age, y | 2.7 (1.3) | 3.6 (1.6) | 3.7 (2.0) | 3.4 (1.8) |
| GH peak, µg/L | 2.9 (2.2) | 3.6 (2.1) | 4.1 (2.4) | 4.0 (2.0) |
| IGF-I SDS | −2.5 (1.0) | −2.5 (0.8) | −2.0 (1.0) | −2.1 (0.7) |
| Cause of GHD | ||||
| Idiopathic, n | 14 | 14 | 13 | 12 |
| Organic, n | – | 1 | 1 | 2 |
Data are mean (SD) unless otherwise stated.
Abbreviations: BMI, body mass index; d, day; FAS, full analysis set (all children who were correctly randomly assigned and received at least 1 dose of randomized treatment); GH, growth hormone; GHD, growth hormone deficiency; HV, height velocity; IGF, insulin-like growth factor; n, number of patients; SDS, SD score; wk, week; y, years.