Table 1.
Demographic and baseline characteristics (safety population)
| Resmetirom 100 mg OL (n = 171) | Resmetirom 100 mg DB (n = 324) | Resmetirom 80 mg DB (n = 327) | Placebo DB (n = 318) | |
|---|---|---|---|---|
| Age, years, mean (s.d.) | 55.6 (11.5) | 55.9 (11.7) | 56.2 (11.7) | 55.7 (12.1) |
| Sex, male, n (%)a | 55 (32.2) | 147 (45.4) | 145 (44.3) | 150 (47.2) |
| Race, n (%) | ||||
| White | 151 (88.3) | 287 (88.6) | 290 (88.7) | 282 (88.7) |
| Black or African American | 10 (5.8) | 22 (6.8) | 21 (6.4) | 20 (6.3) |
| Asian | 6 (3.5) | 6 (1.9) | 6 (1.8) | 7 (2.2) |
| Otherb | 3 (1.8) | 7 (2.1) | 8 (2.4) | 7 (2.2) |
| Missing | 1 (0.6) | 2 (0.6) | 2 (0.6) | 2 (0.6) |
| Ethnicity, Hispanic or Latino, n (%) | 52 (30.4) | 108 (33.3) | 108 (33.0) | 120 (37.7) |
| BMI, kg m−2, mean (s.d.) | 36.1 (6.3) | 35.4 (6.4) | 35.3 (5.9) | 35.2 (5.8) |
| Type 2 diabetes, n (%) | 83 (48.5) | 156 (48.1) | 160 (48.9) | 159 (50.0) |
| Hypertension, n (%) | 119 (69.6) | 246 (75.9) | 249 (76.1) | 242 (76.1) |
| Dyslipidemia, n (%) | 152 (88.9) | 283 (87.3) | 288 (88.1) | 281 (88.4) |
| Hypothyroidism, n (%)c | 76 (44.4) | 34 (10.5) | 39 (11.9) | 35 (11.0) |
| ASCVD, n (%) | 10 (5.8) | 22 (6.8) | 26 (8.0) | 24 (7.5) |
| 10-year ASCVD risk score, % | n = 140 | n = 253 | n = 245 | n = 238 |
| Mean (s.d.) | 11.6 (12.5) | 12.2 (11.7) | 12.7 (11.5) | 13.5 (12.8) |
| Median (Q1, Q3) | 6.6 (3.4, 15.2) | 8.4 (4.0, 16.2) | 9.6 (3.9, 16.5) | 9.4(3.7, 20.0) |
| FibroScan VCTE/LSM, kPa, mean (s.d.) | 7.8 (3.4) | 7.3 (4.1) | 7.4 (4.4) | 7.5 (5.5) |
| FibroScan CAP, dBm, mean (s.d.) | 342.3 (35.6) | 341.4 (34.0) | 339.5 (32.9) | 344.1 (34.0) |
| MRI-PDFF, % fat fraction, mean (s.d.) | 17.9 (7.1) | 18.1 (7.3) | 17.7 (6.7) | 17.8 (6.9) |
| MRE, kPa, mean (s.d.) | 2.8 (0.9) n = 114 | 2.6 (0.5) n = 232 | 2.6 (0.5) n = 219 | 2.60 (0.50) n = 205 |
| FIB-4, mean (s.d.) | 1.0 (0.6) | 1.0 (0.4) | 1.0 (0.5) | 1.0 (0.50) |
| ALT, U l−1, mean (s.d.) | 36.9 (24.2) | 36.2 (25.2) | 37.1 (23.9) | 37.9 (30.4) |
| AST, U l−1, mean (s.d.) | 26.4 (15.3) | 24.9 (12.4) | 25.3 (13.3) | 26.4 (16.4) |
| GGT, U l−1 | ||||
| Mean (s.d.) | 46.9 (55.0) | 41.5 (31.8) | 46.1 (41.0) | 49.9 (62.1) |
| Median (Q1, Q3) | 30 (22, 47) | 32 (22, 49) | 33 (25, 49) | 33(24, 52) |
| ALP, U l−1, mean (s.d.) | 72.8 (23.8) | 70.8 (22.3) | 71.6 (23.8) | 71.3 (24.8) |
| Platelets, 10 l−1, mean (s.d.) | 262.2 (70.7) | 257.5 (60.9) | 254.4 (63.3) | 247.8 (65.9) |
| Albumin, g dl−1, mean (s.d.) | 4.4 (0.3) | 4.3 (0.3) | 4.3 (0.3) | 4.4 (0.3) |
| Bilirubin, mg dl−1, mean (s.d.) | 0.6 (0.2) | 0.6 (0.3) | 0.6 (0.3) | 0.6 (0.3) |
| TC, mg dl−1, mean (s.d.) | 186.9 (47.9) | 178.1 (42.9) | 181.0 (44.2) | 176.8 (43.4) |
| HDL-C, mg dl−1, mean (s.d.) | 45.1 (14.5) | 43.8 (13.0) | 43.6 (14.7) | 43.2 (13.6) |
| LDL-C, mg dl−1, mean (s.d.) | 115.2 (41.0) | 109.1 (36.4) | 111.7 (37.6) | 106.8 (37.2) |
| apoB, mg dl−1, mean (s.d.) | 101.1 (28.4) | 95.5 (25.0) | 98.1 (26.3) | 95.1 (27.1) |
| TG, mg dl−1 | ||||
| Mean (s.d.) | 183.6 (86.2) | 174.1 (93.5) | 177.6 (94.4) | 186.8 (119.2) |
| Median (Q1, Q3) | 157 (126, 220) | 155 (117, 206) | 153 (116, 206) | 158 (122, 215) |
| Lp(a), nmol l−1 | ||||
| Mean (s.d.) | 48.5 (73.1) | 57.6 (77.6) | 60.8 (77.5) | 49.0 (70.2) |
| Median (Q1, Q3) | 23 (11, 54) | 21 (12, 68) | 25 (11, 85) | 22 (9, 46) |
| Baseline medications, n (%) | ||||
| GLP-1 RA | 20 (11.7) | 30 (9.3) | 25 (7.6) | 19 (6.0) |
| Metformin | 71 (41.5) | 138 (42.6) | 137 (41.9) | 136 (42.8) |
| Pioglitazone | 3 (1.8) | 3 (0.9) | 3 (0.9) | 1 (0.3) |
| SGLT2i | 18 (10.5) | 30 (9.3) | 26 (8.0) | 15 (4.7) |
| Statin | 75 (43.9) | 143 (44.1) | 138 (42.2) | 164 (51.6) |
aSex was self-reported by the patient.
bIncludes American Indian or Alaska Native; Native Hawaiian or other Pacific Islander; and Other.
cPatients on thyroxine replacement therapy at baseline.
Median reported for baseline characteristics that showed high s.d.
ASCVD, atherosclerotic cardiovascular disease; FIB-4, fibrosis-4; HDL-C, high-density lipoprotein cholesterol; SGLT2i, sodium/glucose cotransporter-2 inhibitor; TC, total cholesterol.