Table 1 Demographics and baseline characteristics
From: The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial
Characteristic, mean or % | Placebo (n = 18) | PGZ pooled (n = 67) | PGZ 9 mg QW (n = 16) | PGZ 18 mg QW (n = 17) | PGZ 27 mg QW (n = 18) | PGZ 36 mg Q2W (n = 16) | Total (n = 85) |
|---|---|---|---|---|---|---|---|
Age, years | 57.5 | 52.7 | 54.6 | 49.2 | 53.9 | 53.1 | 53.7 |
Male, % | 66.7 | 77.6 | 68.8 | 82.4 | 72.2 | 87.5 | 75.3 |
White, % | 94.4 | 95.5 | 93.8 | 100 | 100 | 87.5 | 95.3 |
BMI, kg m−2 | 33.1 | 33.1 | 32.9 | 32.3 | 34.2 | 32.9 | 33.1 |
Type 2 diabetes, n (%) | 11 (61.1) | 32 (47.8) | 9 (56.3) | 6 (35.3) | 10 (55.6) | 7 (43.8) | 43 (50.6) |
Hypertension, n (%) | 13 (72.2) | 39 (58.2) | 11 (68.8) | 7 (41.2) | 11 (61.1) | 10 (62.5) | 52 (61.2) |
Triglyceride, mg dl−1(median) | 574.8 | 631.3 | 593.3 | 633.3 | 645.3 | 688.5 | 622.0 |
Triglyceride <750 mg dl−1at screening, % | 66.7 | 59.7 | 62.5 | 58.8 | 61.1 | 56.3 | 61.2 |
Triglyceride ≥750 mg dl−1at screening, % | 33.3 | 40.3 | 37.5 | 41.2 | 38.9 | 43.8 | 38.8 |
Non-HDL-C, mg dl−1 | 219.6 | 209.3 | 216.2 | 203.2 | 203.4 | 215.4 | 211.5 |
HDL-C, mg dl−1 | 28.3 | 28.4 | 30.7 | 27.3 | 30.6 | 24.8 | 28.4 |
LDL-C, mg dl−1 | 87.9 | 89.4 | 91.6 | 88.3 | 97.3 | 79.5 | 89.1 |
VLDL-C, mg dl−1 | 133.2 | 117.8 | 123.2 | 115.0 | 104.7 | 130.1 | 120.9 |
VLDL triglyceride, mg dl−1 | 610.2 | 633.6 | 588.0 | 574.2 | 590.0 | 791.4 | 628.9 |
Total cholesterol, mg dl−1 | 247.9 | 237.6 | 246.9 | 230.5 | 234.0 | 240.1 | 239.8 |
Apolipoprotein B, mg dl−1 | 116.3 | 115.3 | 120.1 | 115.3 | 119.3 | 105.9 | 115.5 |
Apolipoprotein C3, mg dl−1 | 29.7 | 29.5 | 29.4 | 28.0 | 30.7 | 30.0 | 29.6 |
Apolipoprotein A1, mg dl−1 | 138.8 | 137.1 | 143.3 | 137.7 | 141.0 | 125.9 | 137.5 |
Lipoprotein (a), nmol l−1 | 42.5 | 45.4 | 48.2 | 21.1 | 55.1 | 58.3 | 44.8 |
Free fatty acids, mmol l−1 | 0.6 | 0.5 | 0.5 | 0.6 | 0.6 | 0.5 | 0.5 |
HbA1c, % | 6.28 | 6.55 | 6.63 | 6.59 | 6.61 | 6.37 | 6.50 |
HbA1c ≥ 6.5%, n (%) | 7 (38.9) | 30 (44.8) | 9 (56.3) | 6 (35.3) | 9 (50.0) | 6 (37.5) | 37 (43.5) |
High-sensitivity C-reactive protein, mg l−1 | 4.6 | 4.5 | 5.9 | 3.6 | 3.2 | 5.7 | 4.6 |
Adiponectin, µg ml−1 | 4.0 | 3.3 | 3.3 | 2.4 | 4.9 | 2.5 | 3.5 |
Fasting plasma glucose, mg dl−1 | 124.4 | 148.7 | 158.5 | 139.3 | 157.5 | 139.0 | 143.6 |
ALT, U l−1 | 29.1 | 33.9 | 36.3 | 36.9 | 33.0 | 29.2 | 32.8 |
AST, U l−1 | 24.2 | 24.7 | 26.7 | 27.6 | 23.7 | 20.6 | 24.6 |
Background lipid-modifying therapy, n (%) | |||||||
Any | 11 (61.1) | 36 (53.7) | 8 (50.0) | 9 (52.9) | 11 (61.1) | 8 (50.0) | 47 (55.3) |
Statins | 9 (50.0) | 29 (43.3) | 6 (37.5) | 9 (52.9) | 7 (38.9) | 7 (43.8) | 38 (44.7) |
High-intensity statins | 4 (22.2) | 17 (25.4) | 6 (37.5) | 5 (29.4) | 4 (22.2) | 2 (12.5) | 21 (24.7) |
Prescription fish oils | 2 (11.1) | 10 (14.9) | 1 (6.3) | 2 (11.8) | 4 (22.2) | 3 (18.8) | 12 (14.1) |
Fibrates | 3 (16.7) | 3 (4.5) | 0 | 0 | 3 (16.7) | 0 | 6 (7.1) |
Ezetimibe | 1 (5.6) | 8 (11.9) | 2 (12.5) | 2 (11.8) | 2 (11.1) | 2 (12.5) | 9 (10.6) |
Bempedoic acid | 0 | 1 (1.5) | 0 | 1 (5.9) | 0 | 0 | 1 (1.2) |
Liver fat fraction by MRI-PDFF, % (n = 24) | 16.5 (n = 6) | 21.3 (n = 18) | 19.8 (n = 3) | 18.0 (n = 5) | 22.4 (n = 7) | 25.5 (n = 3) | 20.1 (n = 24) |
