Parameter, screening mean, ± SD; [and change at week 24] | Placebo (n = 10) | IMCY-0098 dose A (n = 6) | IMCY-0098 dose B (n = 9) | IMCY-0098 dose C (n = 16) | Total (N = 41) |
---|---|---|---|---|---|
Alanine aminotransferase U/L | 24.9, 10.0 [− 0.3, 12.1] | 18.0, 5.7 [6.5, 9.2] | 22.6, 11.5 [− 1.8, 7.7] | 26.8, 23.7 [− 2.3, 17.0] | 24.1, 16.5 [− 0.4,13.1] |
Aspartate aminotransferase, U/L | 23.4, 5.8 [− 4.9, 12.0] | 21.3, 4.1 [1.2, 8.2] | 28.1, 9.6 [− 5.4, 4.8] | 24.0, 9.2 [− 0.3, 8.1] | 24.4, 8.0 [− 2.3, 8.8] |
Lactate dehydrogenase, U/L | 143.1, 17.7 [− 6.6, 12.7] | 142.5, 17.1 [14.7, 29.6] | 154.0, 22.3 [− 17.0, 16.6] | 152.5, 27.2 [− 2.1, 27.2] | 149.1, 22.6 [− 4.0, 23.9] |
Creatine kinase, U/L | 98.8, 66.0 [− 217.7, 498.3] | 109.5, 83.0 [− 11.7, 117.1] | 262.6, 355.0 [− 74.6, 112.7] | 160.1, 161.1 [35.8, 123.1] | 160.2, 201.2 [− 57.2, 275.8] |
Alkaline phosphatase, U/L | 69.2, 20.1 [− 2.0, 19.8] | 65.0, 11.4 [− 3.7, 3.4] | 69.9, 13.4 [− 5.9, 10.2] | 60.7, 17.3 [0.9, 10.1] | 65.4, 16.5 [− 2.0, 12.5] |
Bilirubin, µmol/L | 8.2, 6.9 [− 1.9, 3.7] | 7.4, 3.1 [− 0.1, 3.2] | 6.6, 3.5 [0.9, 3.3] | 15.9, 13.2 [− 2.9, 7.0] | 10.8, 9.9 [− 1.4, 5.2] |
Creatinine, µmol/L | 70.5, 15.1 [2.91, 7.8] | 65.6, 6.6 [1.2, 3.1] | 79.4, 22.4 [− 0.78, 11.5] | 73.6, 9.2 [− 1.5, 6.8] | 73.0, 14.5 [0.13, 7.9] |
Urea, mmol/L | 4.6, 1.4 [− 0.5, 0.6] | 4.2, 0.8 [− 0.1, 1.1] | 5.8, 1.6 [− 1.5, 1.2] | 4.2, 1.2 [− 0.2, 1.1] | 4.7, 1.4 [− 0.5, 1.1] |
Albumin, g/L | 47.8, 3.6 [− 0.9, 3.4] | 47.2, 2.1 [1.7, 2.7] | 47.3, 3.5 [− 0.7, 2.8] | 47.5, 3.2 [− 0.8, 3.2] | 47.5, 3.1 [− 0.4, 3.1] |
Gamma glutamyl transferase, U/L | 20.1, 14.8 [3.7, 11.5] | 15.5, 5.4 [2.0, 5.6] | 15.1, 5.5 [0.1, 3.5] | 14.0, 5.5 [− 1.6, 3.7] | 16.0, 8.8 [0.6, 6.8] |
Glucose, mmol/L | 7.0, 1.1 [− 0.5, 2.3] | 7.9, 1.6 [− 0.9, 1.7] | 6.8, 2.3 [0.4, 1.8] | 7.1, 1.2 [0.1, 2.9] | 7.1, 1.5 [− 0.1, 2.4] |