Table 3.

Change in clinical chemistry parameters from screening to week 24 — safety analysis set

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]