Table 1 Baseline demographic, laboratory, and clinical characteristics

From: ZSP1601, a novel pan-phosphodiesterase inhibitor for the treatment of NAFLD, A randomized, placebo-controlled phase Ib/IIa trial

 

Pooled placebo (N = 9)

ZSP1601

50 mg QD (N = 9)

50 mg BID (N = 9)

100 mg BID (N = 9)

Age, years

37.0 (32.0–40.0)

34.0 (31.0–36.0)

28.0 (25.0–38.0)

30. 0 (24.00–38.0)

Sex

Male

5 (55.6)

9 (100)

8 (88.9)

7 (77.8)

Female

4 (44.4)

0 (0)

1 (11.1)

2 (22.2)

Ethnicity, Asian (Chinese)

9 (100)

9 (100)

9 (100)

9 (100)

Liver chemistries

ALT, U/L

95.33 (21.12)

90.89 (15.11)

106.70 (22.94)

132.34 (62.29)

AST, U/L

49.46 (12.55)

41.19 (8.22)

56.64 (16.69)

68.46 (31.55)

ALP, U/L

79.49 (23.10)

64.08 (22.05)

103.97 (36.76)

96.41 (20.51)

GGT, U/L

93.88 (44.08)

66.19 (34.13)

116.61 (84.35)

84.76 (39.96)

LFC, %

24.39 (10.77)

21.24 (7.75)

21.00 (6.03)

20.99 (9.05)

Noninvasive biomarkers

CAP, dB/m

329.00 (28.31)

337.33 (29.08)

318.89 (44.56)

321.63 (41.85)

LSM, Kpa

7.11 (1.66)

6.51 (2.41)

8.69 (6.63)

6.53 (2.46)

FIB4

0.72 (0.33)

0.62 (0.36)

0.76 (0.35)

0.69 (0.30)

APRI score

0.49 (0.17)

0.41 (0.14)

0.59 (0.19)

0.64 (0.33)

FAST score

0.52 (0.09)

0.48 (0.16)

0.51 (0.24)

0.53 (0.17)

Lipids

TG, mmol/L

2.92 (1.37)

3.16 (2.08)

3.95 (2.31)

1.92 (0.83)

TC, mmol/L

5.25 (1.06)

4.76 (1.07)

5.83 (0.94)

5.24 (0.89)

LDL-C, mmol/L

3.46 (0.78)

2.90 (0.88)

3.88 (0.90)

3.43 (0.72)

HDL-C, mmol/L

1.13 (0.24)

1.15 (0.30)

1.15 (0.22)

1.17 (0.23)

Blood glucose, mmol/L

6.22 (1.08)

5.64 (1.52)

5.64 (0.57)

6.00 (0.95)

Blood insulin, μU/mL

 

128.23 (104.46)

112.08 (64.13)

139.08 (73.66)

151.50 (83.30)

Inflammatory cytokines

TNF-α, pg/mL

0.86 (0.26)

0.74 (0.17)

0.92 (0.30)

0.64 (0.20)

IL-6, pg/mL

3.27 (1.82)

1.64 (0.72)

2.19 (2.40)

2.37 (1.65)

IP-10, pg/mL

125.82 (61.30)

51.81 (35.55)

80.49 (52.20)

115.77 (47.41)

CK-18, pg/mL

1008.56 (1283.75)

509.70 (218.71)

1509.87 (1390.87)

810.53 (632.73)

Obesity parameters

Body weight, kg

81.02 (8.94)

83.92 (8.15)

85.96 (13.19)

81.10 (12.33)

BMI, kg/m2

29.47 (3.57)

29.03 (2.76)

30.32 (2.89)

28.38 (3.04)

Waist circumference, cm

99.80 (6.96)

102.03 (6.83)

100.12 (5.77)

97.02 (11.15)

Abdominal circumference, cm

102.23 (7.33)

102.73 (6.94)

101.22 (8.03)

98.16 (11.76)

  1. Age was expressed as median (interquartile range); Categorical data (sex and ethnicity) were expressed as number (percentage), Other data were expressed as mean (standard deviation). Inflammatory cytokines IL-22 and IL-10 were not detectable at baseline.