Table 2.
Demographics and baseline characteristics at start of the enliGHten trial
| Subjects treated with lonapegsomatropin during the heiGHt trial (n = 103) | Subjects treated with daily somatropin during the heiGHt trial (n = 55) | Subjects treated with lonapegsomatropin during the fliGHt trial (n = 140) | Total (n = 298) | |
|---|---|---|---|---|
| Male, n (%) | 84 (81.6) | 45 (81.8) | 106 (75.7) | 235 (78.9) |
| Age | ||||
| Mean age, years (SD) | 9.5 (2.7) | 9.5 (2.8) | 11.1 (3.9) | 10.3 (3.4) |
| Min, max | 4.4, 14.1 | 4.2, 13.9 | 1.7, 17.8 | 1.7, 17.8 |
| Race, n (%) | ||||
| Asian | 1 (1.0) | 0 (0) | 5 (3.6) | 6 (2.0) |
| Black or African American | 2 (1.9) | 0 (0) | 3 (2.1) | 5 (1.7) |
| Native Hawaiian or other Pacific Islander | 0 (0) | 0 (0) | 2 (1.4) | 2 (0.7) |
| White | 98 (95.1) | 52 (94.5) | 120 (85.7) | 270 (90.6) |
| Multiple/other | 2 (1.9) | 3 (5.5) | 2 (1.4) | 7 (2.3) |
| Unknown | 0 (0) | 0 (0) | 8 (5.7) | 8 (2.7) |
| Country | ||||
| United States | 27 (26.2) | 14 (25.5) | 133 (95.0) | 174 (58.4) |
| Outside of United States | 76 (73.8) | 41 (74.5) | 7 (5.0) | 124 (41.6) |
| Height SDS, mean (SD) | −1.9 (0.7) | −2.1 (0.8) | −1.1 (0.8) | −1.6 (0.9) |
| BMI SDS, mean (SD) | −0.04 (0.9) | −0.41 (1.0) | 0.12 (1.0) | −0.04 (1.0) |
| Average IGF-1 SDSa, mean (SD) | 0.6 (0.9) | −0.05 (1.2) | 1.6 (1.3) | 0.97 (1.3) |
| IGF-1,a ng/mL, mean (SD) | 263.8 (92.0) | 222.6 (115.6) | 410.0 (188.4) | 324.9 (169.0) |
| Tanner stage, n (%) | ||||
| Stage I | 92 (89.3) | 45 (81.8) | 77 (55.0) | 214 (71.8) |
| Stage II | 11 (10.7) | 8 (14.5) | 21 (15.0) | 40 (13.4) |
| Stage III | 0 | 2 (3.6) | 22 (15.7) | 24 (8.1) |
| Stage IV | 0 | 0 | 17 (12.1) | 17 (5.7) |
| Stage V | 0 | 0 | 3 (2.1) | 3 (1.0) |
| Bone age/chronological age ratio, mean (SD) | 0.75 (0.15) | 0.75 (0.14) | 0.87 (0.12) | 0.81 (0.15) |
| Peak stimulated GH prior to hGH therapy, ng/mL, mean (SD) | 5.9 (2.8) | 5.5 (3.0) | 5.9 (2.5) | 5.8 (2.7) |
Abbreviations: BMI, body mass index; GH, growth hormone; hGH, human growth hormone; IGF-1, insulin-like growth factor-1; SDS, SD score.
aIGF-1 values for the heiGHt lonapegsomatropin group were model-derived and represented the average IGF-1 level at the end of the heiGHt trial; IGF-1 samples for the heiGHt trial daily somatropin group were collected at approximately 12 hours postdose of injection at the end of the heiGHt trial; IGF-1 samples for the fliGHt group were collected approximately 96 to 144 hours postdose of lonapegsomatropin injection and represent average weekly levels.