Table 1.
Demographics and clinical characteristics of the study cohort at baseline (intention-to-treat population)
| Characteristic | Placebo (n = 159) |
Lerodalcibep (n = 319) |
|---|---|---|
| Age, years (range) | 53.8 (18–79) | 52.5 (19–80) |
| Female sex, no. (%) | 83 (52.2) | 164 (51.4) |
| Race White no. (%) | 143 (89.9) | 273(85.6) |
| Black/multi-racial no. (%) | 12 (7.5) | 25 (7.8) |
| South Asian no. (%) | 4 (2.5) | 21 (6.6) |
| Body mass index, kg/m2 mean(SD) | 28.79 (5.14) | 28.83 (5.05) |
| Diagnosis of HeFH no. (%) | 159 (100) | 319 (100) |
| On clinical criteria no. (%) | 103 (64.8) | 186 (58.3) |
| On genotyping no. (%) | 56 (35.2) | 133 (41.7) |
| Diabetes mellitus no. (%)a | 18 (11.3) | 31 (9.7) |
| Documented ASCVD no. (%) | 49 (45.0) | 108 (48.9) |
| Very-high risk for ASCVD no. (%) | 109 (68.6) | 221 (69.3) |
| High risk for ASCVD no. (%) | 50 (31.4) | 98 (30.7) |
| Lipid modifying therapy, no. (%) | ||
| Statin; any dose | 141 (88.7) | 281 (88.1) |
| High-intensity statin | 101 (63.5) | 218 (68.3) |
| Not high-intensity statin | 40 (25.2) | 63 (19.7) |
| Ezetimibe | 78 (49.1) | 155 (48.6) |
| Lipid measures at baseline | ||
| LDL-cholesterol (calculated), mmol/L; mean(SD) | 3.79 (1.47) | 3.93 (1.74) |
| LDL-cholesterol (UC), mmol/L; mean(SD) | 3.74 (1.39) | 3.86 (1.66) |
| Total cholesterol, mmol/L; mean(SD) | 5.76 (1.60) | 5.94 (1.84) |
| Non HDL-cholesterol, mmol/L mean(SD) | 4.44 (1.61) | 4.63 (1.87) |
| HDL-cholesterol, mmol/L; mean(SD) | 1.33 (0.39) | 1.31 (0.41) |
| Apolipoprotein B, mg/dL; mean(SD) | 119.9 (37.68) | 123.3 (42.87) |
| Lipoprotein(a), nmol/L; median (IQR) | 46.0 (158) | 57.0 (148) |
| Triglycerides, mmol/L; median (IQR) | 1.17 (0.82) | 1.23 (0.93) |
| PCSK9, ng/mL; mean (SD) | 341 (120)b |
ASCVD, atherosclerotic cardiovascular disease; HeFH, heterozygous familial hypercholesterolemia; UC, preparative ultracentrifugation.
Patient reported.
n = measured in lerodalcibep treated patients only.