Table 1.
Baseline Characteristics
| Pbo/Res (n = 14) | Res/Res (n = 17) | All (n = 31) | |
|---|---|---|---|
| Age, years (SD) | 42.4 (10.5) | 53.1 (11.8) | 48.2 (12.3) |
| Male, n (%) | 8 (57.1) | 8 (47.1) | 16 (51.6) |
| Race, White, n (%) | 14 (100.0) | 13 (76.5) | 27 (87.1) |
| Black | 0 (0) | 1 (5.9 ) | 1 (3.2) |
| Asian | 0 (0) | 2 (11.8) | 2 (6.4) |
| Other | 0 (0) | 1 (5.9) | 1 (3.2) |
| Hispanic, n (%) | 9 (64.3) | 7 (41.2) | 16 (51.6) |
| BMI, mean (SD) | 35.1 (5.2) | 34.5 (5.2) | 35.3 (5.2) |
| T2D, n (%) | 5 (35.7) | 9 (52.9) | 14 (45.2) |
| Hypertension, n (%) | 6 (42.9) | 10 (58.8) | 16 (51.6) |
| NAS, main BL mean (SD) | 4.7 (0.9) | 4.9 (1.1) | 4.8 (1.0) |
| NAS, main week 36 mean (SD) | 4.2 (1.5) | 3.9 (1.4) | 4.1 (1.4) |
| NAS, 2‐point decrease, n (%) | 2 (14.3) | 9 (52.9) | 11 (35.5) |
| Fibrosis stage, main BL mean (SD) | 1.6 (1.0) | 1.8 (1.0) | 1.7 (1.0) |
| Fibrosis stage, main week 36 mean (SD) | 1.8 (1.0) | 2.0 (0.8) | 1.8 (1.0) |
| F0 at week 36, n (%) | 0 | 3 (17.6) | 3 (9.7) |
| F2‐F3 at week 36, n (%) | 7 (50.0) | 13 (76.5) | 20 (64.6) |
| MRI‐PDFF main BL mean% (SD%) | 17.4 (7.6) | 21.0 (6.4) | 19.4 (7.1) |
| MRI‐PDFF main week 36 mean% (SD%) | 18.0 (7.0) | 14.2 (6.1) | 15.9 (6.7) |
| %CFB, main (BL to week 36) | 12.2 (46.6) | −27.9 (37.0) | −9.8 (45.6) |
| ALT (IU/L), main BL | 58.9 (27.4) | 68.3 (40.9) | 64.1 (35.2) |
| ALT (IU/L), OLE BL | 70.6 (51.7) | 58.5 (35.6) | 64.0 (43.2) |
| AST (IU/L), main BL | 36.0 (19.7) | 46.6 (19.5) | 41.8 (20.0) |
| AST (IU/L), OLE BL | 40.9 (24.8) | 43.8 16.4) | 42.5 (20.3) |
| GGT (IU/L), main BL | 70.3 (61.5) | 62.6 (33.1) | 66.1 (47.3) |
| GGT (IU/L), OLE BL | 76.6 (75.1) | 57.6 (30.8) | 66.2 (55.2) |
| Total bilirubin (mg/dL), OLE BL | 0.506 (0.17) | 0.574 (0.20) | 0.543 (0.19) |
| Direct bilirubin (mg/dL), OLE BL | 0.089 (0.035) | 0.106 (0.043) | 0.099 (0.040) |
| Alkaline phosphatase (IU/L), OLE BL | 83.4 (30.1) | 78.0 (20.3) | 79.6 (27.4) |
| PRO‐C3 ng/mL, main BL mean (SD) | 15.3 (8.7) | 23.2 (10.8) | 19.6 (10.5) |
| PRO‐C3 ng/mL, OLE BL mean (SD) | 19.6 (13.6) | 18.4 (6.3) | 19.0 (10.1) |
| C3M ng/mL, main BL, mean (SD) | 11.8 (2.9) | 10.9 (1.9) | 11.3 (2.4) |
| C3M ng/mL, OLE BL, mean (SD) | 12.2 (3.0) | 11.5 (2.3) | 11.8 (2.6) |
| PRO‐C3/C3M, main BL | 1.30 (0.63) | 2.10 (0.89) | 1.74 (0.87) |
| PRO‐C3/C3M, OLE BL | 1.70 (1.00) | 1.70 (0.80) | 1.67 (0.89) |
| FibroScan VCTE (kPa) OLE BL, mean (SD) | 8.3 (2.6) | 11.9 (5.0) | 10.3 (4.4) |
| FibroScan CAP, OLE BL, mean (SD) | 325.5 (77.5) | 317.8 (71.0) | 320.8 (72.5) |
| Direct LDL (mg/dL) OLE BL, mean (SD) | 121 (35.1) | 125.7 (42.9) | 123.7 (39.1) |
| TGs (mg/dL) OLE BL, mean (SD) | 176.1 (110.1) | 178.4 (72.0) | 177.4 (88.8) |
| HDL (mg/dL) OLE BL, mean (SD) | 43.5 (11.2) | 46.8 (14.2) | 45.1 (12.6) |
| ApoB (mg/dL) OLE BL, mean (SD) | 110 (29) | 112 (30) | 110.9 (29.5) |
| ApoCIII (mg/dL), main BL, mean (SD) | 10.3 (3.3) | 11.2 (3.8) | 10.8 (3.6) |
| ApoCIII (mg/dL), OLE BL, mean (SD) | 10.4 (5.3) | 10.6 (3.2) | 10.5 (4.1) |
| Common concomitant meds | |||
| NSAIDs | 4 (28.6) | 8 (47) | 12 (39) |
| Biguanides (metformin) | 4 (28.6) | 7 (41.2) | 11 (35.5) |
| Proton pump inhibitors | 4 (28.6) | 7 (41.2) | 11 (35.5) |
| Statins | 3 (21.4) | 6 (35.3) | 9 (29.0) |
| Angiotensin‐converting enzyme inhibitors | 4 (28.6) | 4 (23.5) | 8 (25.8) |
Note: Data are presented as n (%) or mean (SD). For FibroScan, n = 11; Pbo/Res and Res/Res, n = 14.
Abbreviations: BL, baseline; BMI, body mass index; %CFB, percent change from baseline; HDL, high density lipoprotein; NSAID, nonsteroidal anti‐inflammatory drug; TGs, triglycerides; T2D, type 2 diabetes.