Skip to main content

Table 3 Summary of serum bile acids and serum markers of bile acid synthesis/metabolism

From: Safety, tolerability and pharmacodynamics of apical sodium-dependent bile acid transporter inhibition with volixibat in healthy adults and patients with type 2 diabetes mellitus: a randomised placebo-controlled trial

  Day Number Serum bile acid (μmol/L) C4 (ng/mL) FGF-19 (pg/mL) FGF-21 (pg/mL)
Mean SD Mean SD Mean SD Mean SD
Healthy volunteers
 Placebo 1 12 4.676 3.3066 29.95 12.917 359.2 500.55 174.1 90.84
14 12 2.941 2.2596 15.21 12.211 264.3 280.50 224.2 180.73
28 12 2.951 2.3758 15.23 8.537 259.3 333.54 167.6 112.15
 Volixibat 0.5 mg 1 10 5.886 4.2363 22.87 6.427 304.8 328.52 195.6 155.49
14 10 2.304 1.6197 35.57 25.119 297.0 302.87 219.7 133.12
28 9 2.540 1.9897 30.21 13.358 306.7 247.72 204.6 104.43
 Volixibat 1 mg 1 9 5.614 5.7738 14.49 5.304 495.3 969.34 138.9 118.64
14 9a 4.176 3.9589 23.60 13.736 551.1 1129.55 206.6 195.40
28 9a 1.838 0.9931 24.92 14.686 1056.7 2428.36 150.2 99.92
 Volixibat 5 mg 1 8 2.826 1.4719 30.78 19.365 669.0 1301.49 224.0 111.03
14 8 1.861 1.4777 56.38 43.306 651.4 1324.94 252.3 146.26
28 6 2.872 1.6163 56.52 38.863 784.7 1405.55 215.2 142.22
 Volixibat 10 mg 1 8 2.248 1.7120 13.75 4.602 228.1 239.87 204.1 156.90
14 8 1.959 1.1725 37.51 18.886 186.6 242.72 253.9 165.21
28 8 1.743 0.9222 72.86 35.499 164.6 226.91 212.6 157.95
Patients with T2DM
 Placebo 1 3b 2.370 1.6532 16.60 6.899 211.5 212.84 360.0 300.66
14 3 2.523 2.2756 14.40 3.568 94.3 121.25 463.0 386.47
28 3b 1.340 0.1758 28.73 8.545 173.5 197.28 309.3 184.02
 Volixibat 10 mg 1 8 1.826 1.6175 30.15 14.351 605.8 1264.78 334.0 128.76
14 8c 2.355 1.1042 59.66 28.221 640.1 1399.18 497.9 198.04
28 8 2.118 0.9359 61.81 22.163 114.4 146.91 359.0 178.13
  1. C4 7α-hydroxy-4-cholesten-3-one, FGF fibroblast growth factor, N number of patients for whom data were available, SD standard deviation, T2DM type 2 diabetes mellitus
  2. On day 1 (baseline), measurements were taken before participants received the first dose of study drug. Data are from the pharmacodynamic analysis set
  3. aFibroblast growth factor data available for 8 patients on day 14 and 7 patients on day 28. bFibroblast growth factor data available for 2 patients on day 1 and 2 patients on day 28. cFibroblast growth factor data available for 7 patients on day 14