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Table 2 Changes in blood lipid parameters from baseline to final on-treatment assessment

From: A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults: implications for treatment of non-alcoholic steatohepatitis

Parameter, mmol/L

Placebo

(n = 21)

Volixibat

5 mg b.i.d.

(n = 9)

10 mg q.d.

(n = 9)

20 mg q.d.

(n = 9)

2–5–10–20 mg q.d.

(n = 9)

30 mg q.d.

(n = 9)

40 mg q.d.

(n = 9)

80–40–20 mg q.d.

(n = 9)

Total

(n = 63)

Total cholesterol

−0.20

(− 1.0, 1.7)

−0.90

(− 2.0, 0.3)

−0.40

(− 2.8, 0.4)

−0.70

(− 2.0, − 0.1)

−0.10

(− 0.8, 0.2)

−0.60

(− 1.4, 0.3)

−1.30

(− 1.8, − 0.1)

−1.00

(− 1.5, − 0.6)

−0.70

(− 2.8, 0.4)

LDL cholesterol

0.0260

(− 1.088, 1.838)

−0.9190

(− 1.502, − 0.233)

−0.2975

(− 2.719, 0.570)

−0.7520

(− 1.761, − 0.130)

−0.4925

(− 0.699, 0.156)

−0.6990

(− 1.451, 0.103)

−1.2690

(− 3.341, − 0.337)

−0.8030

(− 1.476, − 0.518)

−0.6990

(− 3.341, 0.570)

HDL cholesterol

− 0.030

(− 0.49, 0.73)

−0.050

(− 0.38, 0.23)

−0.080

(− 0.85, 0.18)

0.000

(− 0.26, 0.18)

0.120

(− 0.03, 0.33)

0.130

(0.00, 0.23)

0.030

(− 0.21, 0.33)

−0.050

(− 0.16, 0.16)

0.000

(− 0.85, 0.33)

Triglycerides

0.000

(− 2.49, 1.00)

0.190

(− 0.11, 3.05)

0.210

(− 0.50, 2.08)

−0.130

(− 0.68, 1.45)

−0.120

(− 0.31, 1.20)

0.060

(− 0.10, 0.32)

−0.010

(− 0.76, 1.24)

−0.200

(− 0.45, 0.05)

−0.010

(− 0.76, 3.05)

VLDL cholesterol

0.0

(−1, 1)

0.0

(0, 1)

0.0

(−1, 1)

0.0

(0, 1)

0.0

(−1, 0)

0.0

(0, 1)

0.0

(−1, 2)

0.0

(− 1, 0)

0.0

(− 1, 2)

  1. Values are median (range). Baseline was the last observation before the first dose of study drug. Data are from the safety analysis set
  2. b.i.d., twice daily; HDL, high-density lipoprotein; LDL, low-density lipoprotein; q.d., once daily; VLDL, very low-density lipoprotein
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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