Table 7.
Safety endpoint parameters
| Baseline | Week 24 | P value | |
|---|---|---|---|
| Body weight (kg) | 68.9 ± 14.9 | 68.6 ± 15.6 | 0.623 |
| BMI (kg/m2) | 25.8 ± 5.0 | 25.6 ± 5.1 | 0.556 |
| CK (IU/L) | 89.0 (70.5, 168.0) | 99.0 (70.5, 160.0) | 0.526 |
| AST (IU/L) | 26.5 ± 14.0 | 23.8 ± 10.2 | 0.056 |
| ALT (IU/L) | 24.8 ± 12.0 | 24.1 ± 10.7 | 0.594 |
| γ-GTP (IU/L) | 33.8 ± 21.7 | 33.6 ± 24.2 | 0.922 |
| Myalgia (n%) | 0 (0) | 6 (13.3) | 0.012 |
Data are expressed as mean ± SD except for CK, which is shown as median (interquartile range)
SD standard deviation, BMI body mass index, CK creatine kinase, AST aspartate aminotransaminase, ALT alanine aminotransaminase, γ-GTP gamma-glutamyltransferase