Skip to main content

Table 4 Summary of blood lipid parameters at baseline and on days 14 and 28

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

Total cholesterol (mmol/L)

LDL-C (mmol/L)

HDL-C (mmol/L)

Triglycerides (mmol/L)

Mean

SD

Mean

SD

Mean

SD

Mean

SD

Healthy volunteers

 Placebo

1

12

4.70

0.964

2.78

0.853

1.38

0.298

1.189

0.3600

14

12

4.78

1.209

3.03

1.112

1.29

0.223

1.031

0.3635

28

12

4.73

1.097

2.87

0.934

1.38

0.322

1.233

0.4302

 Volixibat 0.5 mg

1

10

4.17

0.933

2.39

0.861

1.35

0.314

0.976

0.3523

14

10

4.07

0.686

2.23

0.726

1.31

0.307

1.013

0.3370

28

9

3.99

0.854

2.29

0.851

1.37

0.274

0.936

0.2013

 Volixibat 1 mg

1

9

4.28

0.628

2.43

0.650

1.34

0.274

0.863

0.3278

14

9

3.87

0.650

2.22

0.655

1.29

0.215

0.962

0.6851

28

9

3.97

0.552

2.22

0.576

1.33

0.300

1.024

0.5973

 Volixibat 5 mg

1

8

4.53

0.865

2.81

0.781

1.25

0.227

1.476

0.6576

14

8

4.21

0.825

2.50

0.725

1.23

0.276

1.294

0.7138

28

6

4.58

1.102

2.77

0.967

1.33

0.350

1.522

0.5151

 Volixibat 10 mg

1

8

5.44

0.637

3.04

0.641

1.86

0.421

0.875

0.4316

14

8

4.94

0.774

2.66

0.715

1.80

0.518

0.914

0.5547

28

8

4.98

0.504

2.59

0.559

1.94

0.346

1.055

0.5934

Patients with T2DM

 Placebo

1

3

4.60

0.964

2.83

0.874

1.07

0.115

2.260

1.0817

14

3

4.37

0.586

2.57

0.404

1.03

0.153

2.527

1.1007

28

3

5.03

1.266

2.93

0.603

1.13

0.153

3.070

2.4333

 Volixibat 10 mg

1

8

4.69

1.037

3.01

0.926

1.25

0.245

1.725

0.5263

14

8

4.20

1.135

2.46

1.086

1.25

0.214

2.074

0.8015

28

8

4.68

0.924

2.84

0.890

1.29

0.275

1.933

0.5337

  1. HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, N number of patients for whom data were available, SD standard deviation, T2DM type 2 diabetes mellitus
  2. On day 1 (baseline), measurements of faecal bile acids and serum markers were taken before participants received the first dose of study drug; data are from the pharmacodynamic analysis set