Table 1.
Demographics and baseline characteristics of patients in the DBTP
| Cohort 1 | Cohort 2 | Cohort 3 | ||||
|---|---|---|---|---|---|---|
| Placebo i.v. Q4W (n = 5) | Evinacumab i.v. 15 mg kg−1 Q4W (n = 12) | Placebo i.v. Q4W (n = 6) | Evinacumab i.v. 15 mg kg−1 Q4W (n = 9) | Placebo i.v. Q4W (n = 5) | Evinacumab i.v. 15 mg kg−1 Q4W (n = 14) | |
| Age (years) mean (s.d.) | 43.2 (15.7) | 51.3 (9.4) | 52.8 (13.5) | 48.7 (10.3) | 41.2 (7.8) | 46.1 (11.0) |
| Sex (male) n (%) | 4 (80.0) | 6 (50.0) | 2 (33.3) | 6 (66.7) | 3 (60.0) | 6 (42.9) |
| Race, n (%) | ||||||
| White | 4 (80.0) | 11 (91.7) | 5 (83.3) | 7 (77.8) | 3 (60.0) | 11 (78.6) |
| Black or African American | 0 | 0 | 0 | 1 (11.1) | 0 | 0 |
| Asian | 0 | 1 (8.3) | 0 | 1 (11.1) | 1 (20.0) | 3 (21.4) |
| Other | 1 (20.0) | 0 | 1 (16.7) | 0 | 1 (20.0) | 0 |
| Ethnicity, n (%) | ||||||
| Hispanic or Latino | 0 | 2 (16.7) | 1 (16.7) | 1 (11.1) | 1 (20.0) | 1 (7.1) |
| Not Hispanic or Latino | 5 (100) | 10 (83.3) | 5 (83.3) | 8 (88.9) | 4 (80.0) | 13 (92.9) |
| BMI (kg m−2) mean (s.d.) | 26.6 (4.1) | 26.8 (5.2) | 27.9 (5.6) | 31.5 (4.3) | 30.0 (1.9) | 28.9 (5.0) |
| History of AP, n (%) | 5 (100) | 12 (100) | 6 (100) | 9 (100) | 5 (100) | 14 (100) |
| Time from the most recent occurrence of AP (years) mean (s.d.)a | 5.5 (7.8) | 8.5 (9.6) | 1.9 (1.1) | 3.9 (3.8) | 1.8 (1.6) | 3.0 (4.6) |
| Coronary heart disease, n (%) | 1 (20.0) | 1 (8.3) | 2 (33.1) | 1 (11.1) | 1 (20.0) | 5 (35.7) |
| Concomitant LLTs, n (%) | 3 (60.0) | 6 (50.0) | 6 (100) | 9 (100) | 4 (80.0) | 10 (71.4) |
| Fibrates | 2 (40.0) | 5 (41.7) | 5 (83.3) | 8 (88.9) | 4 (80.0) | 8 (57.1) |
| Statins | 2 (40.0) | 3 (25.0) | 3 (50.0) | 6 (66.7) | 3 (60.0) | 9 (64.3) |
| High-intensity statins | 1 (20.0) | 1 (8.3) | 1 (16.7) | 4 (44.4) | 1 (20.0) | 9 (64.3) |
| Nicotinic acid and derivatives | 0 | 1 (8.3) | 0 | 3 (33.3) | 0 | 0 |
| Otherb | 3 (60.0) | 5 (41.7) | 5 (83.3) | 7 (77.8) | 0 | 8 (57.1) |
| ≥2 LLTs | 2 (40.0) | 5 (41.7) | 6 (100.0) | 7 (77.8) | 2 (40.0) | 8 (57.1) |
| ≥3 LLTs | 2 (40.0) | 3 (25.0) | 2 (33.3) | 6 (66.7) | 0 (0.0) | 7 (50.0) |
| ≥4 LLTs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (7.1) |
| ≥5 LLTs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Concomitant antihyperglycemic drugs, n (%) | 2 (40.0) | 5 (41.7) | 3 (50.0) | 7 (77.8) | 5 (100) | 12 (85.7) |
| Biguanides (metformin) | 1 (20.0) | 5 (41.7) | 3 (33.3) | 4 (44.4) | 3 (60.0) | 8 (57.1) |
| Insulin (fast acting) | 2 (40.0) | 0 | 2 (33.3) | 4 (44.4) | 1 (20.0) | 6 (42.9) |
| Insulin (long acting) | 2 (40.0) | 2 (16.7) | 1 (16.7) | 3 (33.3) | 1 (20.0) | 4 (28.6) |
| SGLT2 inhibitors | 0 (0.0) | 0 (0.0) | 1 (16.7) | 4 (44.4) | 3 (60.0) | 3 (21.4) |
| GLP-1 inhibitors | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 2 (14.3) |
aTime from diagnosis to study randomization.
bIncludes omega-3-acid ethyl ester, omega-3 fatty acids, eicosapentaenoic acid ethyl ester, ezetimibe, fish oil, combination of docosahexaenoic acid, eicosapentaenoic acid and fish oil, eicosapentaenoic acid and omega-3 triglycerides.
BMI, body mass index; GLP-1, glucagon-like peptide-1; LLT, lipid-lowering therapy; Q4W, every 4 weeks; SGLT2, sodium glucose co-transporter 2.