TABLE 1.
Demographics and baseline characteristics
| Demographics and baseline characteristics | TXR140 N = 50 | CVC N = 48 | TXR140 + CVC N = 47 | TXR90 + CVC N = 48 |
|---|---|---|---|---|
| Age (y), mean (± SD) | 54.8 ± 13.4 | 53.7 ± 11.8 | 54.7 ± 12.7 | 54.9 ± 12.3 |
| Male, n (%) | 20 (40.0) | 17 (35.4) | 18 (38.3) | 25 (52.1) |
| Race, n (%) | ||||
| Caucasian | 41 (82.0) | 44 (91.7) | 40 (85.1) | 43 (89.6) |
| Asian | 7 (14.0) | 4 (8.3) | 5 (10.6) | 5 (10.4) |
| Black | 1 (2.0) | 0 | 2 (4.3) | 0 (0.0) |
| Unknown | 1 (2.0) | 0 | 0 | 0 |
| BMI (kg/m2), mean (± SD) | 33.7 ± 6.6 | 35.7 ± 8.4 | 34.7 ± 6.9 | 34.3 ± 7.3 |
| Diabetes, n (%) | 39 (78.0) | 41 (85.4) | 39 (83.0) | 40 (83.3) |
| Lipid-lowering medication, n (%) | 22 (44.0) | 23 (47.9) | 33 (70.2) | 29 (60.4) |
| AST, mean (±SD) | 38.6 ± 18.0 | 35.1 ± 13.0 | 42.1 ± 25.2 | 41.4 ± 25.8 |
| ALT, mean (±SD) | 49.1 ± 25.3 | 40.9 ± 15.7 | 51.1 ± 28.6 | 51.8 ± 33.0 |
| ELF, mean (±SD) | 9.6 ± 0.8 | 9.5 ± 1.0 | 9.4 ± 0.7 | 9.6 ± 0.8 |
| HOMA-IR, mean (±SD) | 8.4 ± 7.6 | 7.0 ± 4.8 | 7.1 ± 6.2 | 10.5 ± 14.5 |
| FIB-4, mean (±SD) | 1.3 ± 0.7 | 1.3 ± 0.6 | 1.4 ± 0.9 | 1.3 ± 0.8 |
| Histological characteristics | ||||
| Fibrosis (NASH CRN), real-time biopsya, n (%) | ||||
| Stage 1 | 0 | 0 | 0 | 0 |
| Stage 2 | 17 (34.0) | 10 (20.8) | 10 (21.3) | 17 (35.4) |
| Stage 3 | 32 (64.0) | 38 (79.2) | 37 (78.7) | 30 (62.5) |
| Stage 4 | 1 (2.0) | 0 | 0 | 1 (2.1) |
| NASH diagnosis by CRN, n (%) | 50 (100.0) | 48 (100.0) | 47 (100.0) | 48 (100.0) |
| NAS total score (mean ± SD) | 5.2 ± 0.93 | 5.4 ± 0.82 | 5.4 ± 1.06 | 5.2 ± 1.02 |
| Steatosis, n (%) | ||||
| 1 (5%–33%) | 42 (84.0) | 38 (79.2) | 39 (83.0) | 41 (85.4) |
| 2 (34%–66%) | 8 (16.0) | 10 (20.8) | 8 (17.0) | 7 (14.6) |
| Lobular inflammation, n (%) | ||||
| 1 (< 2 foci/*field) | 3 (6.0) | 2 (4.2) | 3 (6.4) | 4 (8.3) |
| 2 (2–4 foci/*field) | 24 (48.0) | 24 (50.0) | 18 (38.3) | 25 (52.1) |
| 3 (>4 foci/*field) | 23 (46.0) | 22 (45.8) | 26 (55.3) | 19 (39.6) |
| Hepatocyte ballooning, n (%) | ||||
| 1 (mild, few) | 17 (34.0) | 11 (22.9) | 12 (25.5) | 13 (27.1) |
| 2 (moderate, many) | 33 (66.0) | 37 (77.1) | 35 (74.5) | 35 (72.9) |
a
Real-time readings of liver biopsies were performed at baseline to assess eligibility for entry into the study.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; CRN, clinical research network; CVC, cenicriviroc; ELF, enhanced liver fibrosis; FIB-4, fibrosis-4; HOMA-IR, homeostatic model assessment for insulin resistance; N, number of patients in group; n, number of patients with outcome; NAS, NAFLD activity score; TXR90, tropifexor 90 µg; TXR140, tropifexor 140 µg.