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Table 3 Change in clinical chemistry parameters from screening to week 24 — safety analysis set

From: First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes

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]