Table 1.
Baseline Demographics and Disease Characteristics of Randomized Subjects per Treatment Group
|
CVC 150 mg (N = 145) |
Placebo (N = 144) |
All (N = 289)a |
|
|---|---|---|---|
| Demographics | |||
| Mean age, year (SD) | 54.6 (10.2) | 53.7 (11.0) | 54.1 (10.6) |
| Female, no. (%) | 73 (50.3) | 79 (54.9) | 152 (52.6) |
| Race or ethnicity, no. (%) | |||
| White | 129 (89.0) | 121 (84.0) | 250 (86.5) |
| Black | 5 (3.4) | 3 (2.1) | 8 (2.8) |
| Asian | 6 (4.1) | 15 (10.4) | 21 (7.3) |
| Hispanic ethnicity | 23 (15.9) | 25 (17.4) | 48 (16.6) |
| Serum biochemistry | |||
| Mean alanine aminotransferase, U/L (SD) | 61.3 (35.2) | 65.5 (39.6) | 63.4 (37.5) |
| Mean aspartate aminotransferase, U/L (SD) | 43.7 (22.0) | 48.3 (24.0) | 46.0 (23.1) |
| Mean alkaline phosphatase, U/L (SD) | 79.0 (20.9) | 80.8 (27.8) | 79.9 (24.5) |
| Mean gamma‐glutamyl transferase, U/L (SD) | 69.6 (79.0) | 65.2 (43.5) | 67.4 (63.7) |
| Mean total bilirubin, mg/dL (SD) | 0.510 (0.531) | 0.483 (0.273) | 0.496 (0.422) |
| Lipids | |||
| Triglycerides | |||
| Mean, mg/dL (SD) | 180.3 (149.0) | 174.5 (110.1) | 177.4 (130.8) |
| >150 mg/dL, no. (%) | 70 (48.3) | 71 (49.3) | 141 (48.8) |
| Mean cholesterol, mg/dL (SD) | |||
| Total | 192.5 (48.9) | 187.9 (47.4) | 190.2 (48.1) |
| High‐density lipoprotein | 42.1 (12.2) | 40.9 (13.2) | 41.5 (12.7) |
| Low‐density lipoprotein | 121.9 (44.4) | 118.7 (42.8) | 120.3 (43.6) |
| Very‐low‐density lipoprotein | 36.1 (30.0) | 34.9 (22.0) | 35.5 (26.3) |
| Metabolic factors | |||
| Mean body weight, kg (SD) | 95.1 (20.4) | 97.1 (21.9) | 96.1 (21.1) |
| Mean BMI, kg/m2 (SD) | 33.6 (5.7) | 34.1 (7.2) | 33.9 (6.5) |
| Mean HbA1c, % (SD) | 6.71 (1.36) | 6.37 (1.15) | 6.54 (1.27) |
| T2DM, no. (%) | 82 (57.2) | 64 (44.4) | 146 (50.5) |
| ≥3 criteria of MetS, no. (%) | 104 (71.7) | 104 (72.2) | 208 (72.0) |
| Histological features | |||
| NAFLD activity score | |||
| Mean total (SD) | 5.3 (1.1) | 5.4 (1.0) | 5.3 (1.0) |
| Mean steatosis (SD) | 1.4 (0.6) | 1.4 (0.5) | 1.4 (0.6) |
| Mean lobular inflammation (SD) | 2.4 (0.6) | 2.4 (0.6) | 2.4 (0.6) |
| Mean hepatocellular ballooning (SD) | 1.5 (0.5) | 1.5 (0.5) | 1.5 (0.5) |
| NAS | |||
| = 4, no. (%) | 39 (26.9) | 35 (24.3) | 74 (25.6) |
| ≥5, no. (%) | 106 (73.1) | 108 (75.0) | 214 (74.0) |
| Fibrosis stage (NASH CRN) | |||
| 1, no. (%) | 47 (32.4) | 48 (33.3) | 95 (32.9) |
| 2, no. (%) | 42 (29.0) | 40 (27.8) | 82 (28.4) |
| 3, no. (%) | 56 (38.6) | 55 (38.2) | 111 (38.4) |
a
One subject was randomized in error without an adequate screening biopsy.