Table 2.
Change From Baseline in Study Endpoints
| Parameter | Baseline (SD) | Mean absolute change (SD) |
P value Mean absolute change |
Mean percent change (SD) |
P value Mean percent change |
|---|---|---|---|---|---|
| MRI-PDFF, % | |||||
| ITT population (n = 17)a | 17.8 (10.7) | −2.2 (3.3) | P = .007 | −13.2 | P = .007 |
| Baseline PDFF ≥10% (n = 14)a | 20.6 (9.6) | −2.7 (3.4) | P = .013 | −16.2 | P = .011 |
| FibroScan CAP score, dB/m | |||||
| ITT population (n = 17) | 334.1 (19.8) | −18.8 (30.2) | P = .021 | −5.7 (9.1) | P = .019 |
| Baseline PDFF ≥10% (n = 14) | 336.5 (20.5) | −16.7 (27.9) | P = .043 | −5.0 (8.2) | P = .040 |
| Liver stiffness measurement, kPA | |||||
| ITT population (n = 17)a | 8.22 (2.7) | 0.07 (3.0) | P = .411 | −0.94 (31.8) | P = .404 |
| Baseline PDFF ≥10% (n = 14)a | 8.45 (2.8) | −0.43 (1.9) | P = .420 | −5.31 (21.8) | P = .340 |
| Fast™ score (%) (n = 17)a | 0.39 (0.25) | −0.13 (0.16) | P = .006 | −20.4 (71.1) | P = .011 |
| ALT (IU/L)b | |||||
| ITT population (n = 17) | 48.6 (31.4) | −17.1 (18.6) | P = .002 | −24.7 (35.0) | P = .004 |
| Elevated baseline ALT (n = 13) | 59.0 (28.6) | −22.5 (17.6) | P = .001 | −34.6 (19.3) | P = <0.001 |
| FIB-4 (n = 17)a | 1.1 (0.5) | −0.2 (0.3) | P = .051 | −13.4 (19.8) | P = .045 |
| Weight (lbs) (n = 17)a | 236.0 (45.6) | −6.7 (−9.5) | P = .005 | −2.9 (4.1) | P = .008 |
| Parameter | Baseline (SD) | Mean absolute change (SD) | P value |
|---|---|---|---|
| Health-related quality of life (CDC-HRQOL) (n = 9)a | 15.6 (11.1) | −2.2 (11.3) | P = .500 |
| Parameter | Score |
|---|---|
| Net Promoter Score (n = 16) | +75.0 |
| Promoter, % | 81.3% |
| Passive, % | 12.5/% |
| Detractor, % | 6.3% |
a
Indicates P value obtained from a one sample Wilcoxon rank sum test. Otherwise, P value obtained from a one-sample t-test.
b
Elevated ALT defined a priori as results > 19 IU/L in females and >30 IU/L in males.