Table 1.
Demographics and Baseline Clinical Characteristics *
| All Participants (N=182) |
Crinecerfont (N=122) |
Placebo (N=60) |
|
|---|---|---|---|
| Age – yr | 30.8±9.9 | 31.3±9.8 | 29.8±10.2 |
| Male – no. (%) | 92 (50.5) | 61 (50.0) | 31 (51.7) |
| White – no. (%) | 164 (90.1) | 107 (87.7) | 57 (95.0) |
| Glucocorticoid daily dose in hydrocortisone equivalents – mg/day | 32.3±9.3 | 32.4±9.2 | 32.1±9.5 |
| Adjusted for body surface area – mg/m2/day | 17.6±4.9 | 17.5±4.5 | 17.9±5.5 |
| Glucocorticoid type – no. (%) | |||
| Hydrocortisone alone | 106 (58.2) | 71 (58.2) | 35 (58.3) |
| Prednisone, prednisolone, or methylprednisolone, with or without hydrocortisone | 53 (29.1) | 34 (27.9) | 19 (31.7) |
| Dexamethasone, with or without another glucocorticoid | 23 (12.6) | 17 (13.9) | 6 (10.0) |
| Fludrocortisone – no. (%) | 157 (86.3) | 107 (87.7) | 50 (83.3) |
| Body weight – kg | 79.3± 18.3 | 80.8±17.8 | 76.2±18.9 |
| Body mass index – kg/m2 | 29.8±7.0 | 30.1±6.9 | 29.0±7.1 |
| Percent total fat mass† | 35.7±9.2 | 36.3±9.0 | 34.6±9.5 |
| Homeostatic model assessment for insulin resistance‡ | 3.2±2.8 | 3.2±2.7 | 3.1±3.1 |
| Androstenedione – ng/dL§ | 620±729 | 635±796 | 590±572 |
| 17-hydroxyprogesterone – ng/dL§ | 9467±8829 | 9314±8560 | 9787±9435 |
| Testicular adrenal rest tumors (male participants) – no. (%)¶ | 53 (66.3) | 35 (66.0) | 18 (66.7) |
Mean values (± standard deviation) are presented for all 182 randomized participants unless indicated otherwise.
Number of participants with missing percent total fat mass (18 crinecerfont, 7 placebo).
In 172 participants (117 crinecerfont, 55 placebo) without diabetes mellitus.
Based on pre-morning glucocorticoid dose samples. Normal ranges and conversion factors for conventional units to standard international units are in Appendix Table S2. Number of participants with missing hormone or hormone precursor assessments at baseline: androstenedione (1 crinecerfont, 1 placebo); 17-hydroxyprogesterone (1 crinecerfont, 2 placebo).
Presence of testicular adrenal rest tumors based on 80 male participants (53 crinecerfont, 27 placebo) who had available testicular ultrasound assessments at baseline.