Table 1 Participant demographics and baseline characteristics
Single Ascending Dose Cohorts | |||||||
|---|---|---|---|---|---|---|---|
Parameter | Placebo n = 4 | Olezarsen n = 16 | Overall N = 20 | ||||
30 mg n = 5 | 60 mg n = 5 | 90 mg n = 6 | |||||
Age, years, mean (SD) | 49.8 (11.95) | 37.8 (11.95) | 45.6 (10.36) | 41.7 (10.42) | 43.3 (11.08) | ||
Sex, n (%) | |||||||
Male | 3 (75.0) | 4 (80.0) | 4 (80.0) | 4 (66.7) | 15 (75.0) | ||
Female | 1 (25.0) | 1 (20.0) | 1 (20.0) | 2 (33.3) | 5 (25.0) | ||
Asian race, n (%) | 4 (100.0) | 5 (100.0) | 5 (100.00) | 6 (100.0) | 20 (100.0) | ||
Weight, kg, mean (SD) | 66.8 (5.15) | 64.1 (7.25) | 66.3 (9.78) | 70.2 (11.01) | 67.0 (8.54) | ||
BMI, kg/m2, mean (SD) | 24.2 (1.34) | 23.3 (2.08) | 23.6 (1.77) | 24.6 (2.58) | 23.9 (1.97) | ||
ApoC-III, mg/dL, mean (SD) | 14.5 (4.70) | 11.7 (1.88) | 14.2 (5.83) | 16.4 (6.95) | 14.3 (5.22) | ||
ApoB-100, mg/dL, mean (SD) | 92.5 (14.96) | 94.5 (34.26) | 93.9 (25.88) | 94.8 (28.01) | 94.0 (25.11) | ||
Total cholesterol, mg/dL, mean (SD) | 200.9 (26.95) | 196.6 (45.27) | 199.4 (36.72) | 215.3 (59.18) | 203.8 (42.59) | ||
HDL cholesterol, mg/dL, mean (SD) | 52.9 (3.40) | 57.4 (12.95) | 53.5 (11.36) | 56.1 (15.10) | 55.1 (11.30) | ||
LDL cholesterol, mg/dL, mean (SD) | 124.8 (19.62) | 117.0 (48.12) | 117.7 (37.27) | 125.3 (45.29) | 121.2 (37.37) | ||
VLDL cholesterol, mg/dL, mean (SD) | 30.5 (20.17) | 21.2 (7.97) | 30.3 (18.71) | 43.0 (24.42) | 31.9 (19.45) | ||
Triglycerides, mg/dL, mean (SD) | 153.6 (101.49) | 106.1 (39.59) | 152.0 (93.13) | 214.8 (121.64) | 159.7 (97.03) | ||
CRP, mg/dL, mean (SD) | 0.10 (0.029) | 0.13 (0.220) | 0.05 (0.041) | 0.07 (0.061) | 0.09 (0.112) | ||
Multiple Dose Cohort | |||||||
Parameter | Placebo n = 2 | Olezarsen 60 mg n = 6 | Overall N = 8 | ||||
Age, years, mean (SD) | 32.5 (2.12) | 41.8 (13.89) | 39.5 (12.54) | ||||
Gender, n (%) | |||||||
Male | 2 (100.0) | 3 (50.0) | 5 (62.5) | ||||
Female | 0 | 3 (50.0) | 3 (37.5) | ||||
Asian race, n (%) | 2 (100.0) | 6 (100.0) | 8 (100.0) | ||||
Weight, kg, mean (SD) | 67.0 (7.14) | 63.5 (9.07) | 64.3 (8.29) | ||||
BMI, kg/m2, mean (SD) | 22.3 (2.90) | 23.7 (4.18) | 23.4 (3.76) | ||||
ApoC-III, mg/dL, mean (SD) | 11.0 (1.24) | 13.9 (4.44) | 13.2 (4.02) | ||||
Apolipoprotein B-100, mg/dL, mean(SD) | 68.3 (12.37) | 98.3 (17.72) | 90.8 (20.98) | ||||
Total cholesterol, mg/dL, mean (SD) | 182.8 (17.32) | 226.0 (33.42) | 215.2 (35.23) | ||||
HDL cholesterol, mg/dL, mean (SD) | 68.8 (16.62) | 53.5 (11.55) | 57.3 (13.59) | ||||
LDL cholesterol, mg/dL, mean (SD) | 108.0 (47.38) | 149.3 (27.76) | 139.0 (35.18) | ||||
VLDL cholesterol, mg/dL, mean (SD) | 16.5 (2.83) | 37.2 (16.79) | 32.0 (17.15) | ||||
Triglycerides, mg/dL, mean (SD) | 83.0 (14.85) | 185.3 (83.56) | 159.8 (85.22) | ||||
CRP, mg/dL, mean (SD) | 0.22 (0.219) | 0.14 (0.158) | 0.16 (0.161) | ||||