Table 1.
Baseline characteristics
| Characteristic | Placebo | 100 mg | 300 mg | 500 mg | Pooled | |
|---|---|---|---|---|---|---|
| Disposition and analytical population | ||||||
| Total enrolled: safety population | 16 | 16 | 15 | 15 | 62 | |
| Withdrew before 12/13 visits | 1 (6%) | 1 (6%) | 0 (0%) | 1 (7%) | 3 (5%) | |
| Completed 12/13 visits: unabbridged efficacy population | 15 (94%) | 15 (94%) | 15 (100%) | 14 (93%) | 59 (95%) | |
| Severe outlier on plasma D‐4F PKs | 0 (0%) | 0 (0%) | 0 (0%) | 1 (7%) | 1 (2%) | |
| PK outlier Dropped: Censored PKs population | 15 (94%) | 15 (94%) | 15 (100%) | 13 (87%) | 58 (94%) | |
| Demographics | ||||||
| Men | 14 (88%) | 12 (75%) | 9 (60%) | 11 (73%) | 46 (74%) | |
| Women, uncensored | 2 (13%) | 4 (25%) | 6 (40%) | 4 (27%) | 16 (26%) | |
| Age, years | 61.0 (11.8) | 59.2 (9.5) | 59.9 (8.4) | 62.0 (8.0) | 60.5 (9.4) | |
| Race/ethnicity (nonexclusive categories) | ||||||
| Native American | 1 (6%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | |
| African American | 2 (13%) | 3 (19%) | 5 (33%) | 1 (7%) | 11 (18%) | |
| White | 12 (75%) | 13 (81%) | 10 (67%) | 14 (93%) | 49 (79%) | |
| Multiracial | 1 (6%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | |
| Hispanic | 1 (6%) | 0 (0%) | 1 (7%) | 0 (0%) | 2 (3%) | |
| Anthropometrics | ||||||
| Height, cma | Men | 174.3 (4.9) | 176.8 (7.3) | 176.1 (7.1) | 178.1 (5.9) | 176.2 (6.2) |
| Women | 159.5 (7.8) | 157.1 (6.0) | 164.6 (4.1) | 156.0 (7.0) | 159.9 (6.5) | |
| Total body mass, kg | 94.7 (15.5) | 96.7 (16.1) | 92.2 (19.7) | 92.4 (20.2) | 94.0 (17.6) | |
| IBM, kga | Men | 69.8 (4.4) | 72.1 (6.7) | 71.5 (6.4) | 73.2 (5.3) | 71.5 (5.6) |
| Women | 51.9 (7.0) | 49.8 (5.5) | 56.5 (3.7) | 48.7 (6.4) | 52.3 (5.9) | |
| Lean body mass, kga | Men | 66.8 (6.8) | 69.1 (7.6) | 65.4 (9.0) | 67.4 (8.9) | 67.3 (7.8) |
| Women | 47.0 (3.4) | 47.1 (5.2) | 52.7 (7.4) | 46.2 (7.0) | 49.0 (6.6) | |
| Body surface area, m2 b | Men | 1.98 (0.16) | 2.05 (0.20) | 1.97 (0.22) | 2.02 (0.20) | 2.00 (0.19) |
| Women | 1.74 (0.08) | 1.76 (0.17) | 1.92 (0.27) | 1.73 (0.24) | 1.81 (0.22) | |
| Body mass index, kg/m2 | 31.8 (4.2) | 32.6 (3.8) | 31.2 (5.9) | 31.2 (6.2) | 31.7 (5.0) | |
| Major sources of risk (nonexclusive categories) | ||||||
| CHD | 11 (69%) | 6 (38%) | 8 (53%) | 10 (67%) | 35 (56%) | |
| DM | 8 (50%) | 11 (69%) | 8 (53%) | 7 (47%) | 34 (55%) | |
| Other ASCVD (e.g., PAD, AAA, CVD) | 0 (0%) | 1 (6%) | 0 (0%) | 0 (0%) | 1 (2%) | |
| FRS >20% absent CHD, ASCVD, or DM | 1 (6%) | 0 (0%) | 0 (0%) | 1 (7%) | 2 (3%) | |
| CHD and DM | 3 (19%) | 1 (6%) | 1 (7%) | 2 (13%) | 7 (11%) | |
| CHD absent other ASCVD and DM | 7 (44%) | 4 (25%) | 8 (53%) | 7 (47%) | 26 (42%) | |
| Hypertension | 12 (75%) | 13 (81%) | 9 (60%) | 10 (67%) | 44 (71%) | |
| HDLs | ||||||
| HDL‐C, mg/dLc | Men | 41.3 (7.4) | 45.3 (12.0) | 42.4 (11.8) | 42.2 (7.8) | 42.8 (9.6) |
| Women | 76.0 (17.0) | 48.3 (12.8) | 54.0 (12.8) | 58.8 (14.4) | 56.5 (14.9) | |
| ApoA‐I, mg/dLa | Men | 109.6 (14.2) | 113.5 (16.5) | 104.9 (15.4) | 115.7 (11.1) | 111.2 (14.5) |
| Women | 148.5 (16.3) | 124.0 (16.3) | 120.3 (10.4) | 140.3 (14.1) | 131.9 (16.7) | |
| Predose HDL inflammatory index, UR | 1.25 (0.36) | 1.21 (0.36) | 1.35 (0.46) | 1.22 (0.22) | 1.26 (0.36) | |
| Atherogenic lipoproteins | ||||||
| Non‐HDL‐C, mg/dL | 102.1 (28.8) | 107.6 (32.9) | 112.7 (34.1) | 99.5 (23.5) | 105.5 (29.8) | |
| Apo B100, mg/dL | 72.2 (18.3) | 74.1 (18.7) | 77.4 (22.7) | 69.7 (12.3) | 73.2 (17.9) | |
| TG, mg/dL, median, PSD | 143 (86.3) | 127 (54.8) | 99 (66.7) | 92 (71.1) | 110 (71.9) | |
| VLDL‐C, mg/dL | 25.0 (16.4) | 23.3 (12.8) | 20.6 (12.7) | 25.7 (19.7) | 23.6 (15.4) | |
| LDL‐C UC, mg/dL | 77.1 (24.9) | 84.4 (27.8) | 92.1 (35.8) | 73.9 (18.6) | 81.8 (27.7) | |
AAA, abdominal aortic aneurysm; Apo, apolipoprotein; ASCVD, atherosclerotic cardiovascular disease; CHD, coronary heart disease; CVD, cardiovascular disease; DM, diabetes mellitus; FRS, Framingham risk score; HDL, high‐density lipoprotein; HDL‐C, high‐density lipoprotein‐cholesterol; IBM, ideal body mass; PAD, peripheral artery disease; PK, pharmacokinetic; PSD, pseudo‐SD; TG, triglyceride; UC, by ultracentrifugation; UR, unit rate; VLDL‐C, very low‐density lipoprotein‐cholesterol.
Unless otherwise stated, continuous data are presented as mean (SD). Skewed data are presented as median (pseudo‐SD [PSD]). Significance test for interaction by gender: ± <0.1, a P < 0.05, b P < 0.01, c P < 0.001, a P < 0.0001.