Table 1. Patient Baseline Characteristics Among the Full Analysis Seta.
| Characteristic | Zilebesiran | Placebo (n = 75) | |||
|---|---|---|---|---|---|
| 150 mg every 6 mo (n = 78) | 300 mg every 6 mo (n = 73) | 300 mg every 3 mo (n = 75) | 600 mg every 6 mo (n = 76) | ||
| Age, mean (SD), y | 55.5 (10.6) | 56.4 (10.3) | 57.7 (10.6) | 57.4 (10.2) | 56.8 (11.2) |
| Women, No. (%) | 39 (50) | 29 (40) | 30 (40) | 31 (41) | 38 (51) |
| Men, No. (%) | 39 (50) | 44 (60) | 45 (60) | 45 (59) | 37 (49) |
| Race, No. (%)b | |||||
| American Indian or Alaska Native | 1 (1) | 0 | 0 | 0 | 0 |
| Asian | 4 (5) | 2 (3) | 7 (9) | 5 (7) | 5 (7) |
| Black or African American | 20 (26) | 17 (23) | 19 (25) | 19 (25) | 18 (24) |
| Native Hawaiian or Pacific Islander | 0 | 0 | 1 (1) | 0 | 0 |
| White | 53 (68) | 54 (74) | 48 (64) | 52 (68) | 52 (69) |
| Ethnicity, No. (%)b | |||||
| Hispanic or Latino | 19 (24) | 16 (22) | 10 (13) | 20 (26) | 9 (12) |
| Not Hispanic or Latino | 59 (76) | 57 (78) | 65 (87) | 56 (74) | 66 (88) |
| Body mass index ≥30, No. (%) | 46 (59) | 46 (63) | 40 (53) | 45 (59) | 37 (49) |
| Type 2 diabetes, No. (%)c | 14 (18) | 11 (15) | 17 (23) | 16 (21) | 10 (13) |
| Receiving ≥1 hypertensive agent before study enrollment, No. (%)d | 43 (55) | 55 (75) | 57 (76) | 63 (83) | 55 (73) |
| 24-h ambulatory blood pressure, mean (SD), mm Hg | |||||
| Systolic | 140.6 (8.5) | 142.5 (8.8) | 141.6 (7.7) | 143.1 (9.0) | 141.1 (7.9) |
| Diastolic | 81.7 (8.3) | 82.3 (8.7) | 82.0 (8.6) | 81.4 (8.3) | 81.7 (7.8) |
| Mean office BP, mm Hg (SD) | |||||
| Systolic | 142.0 (10.9) | 143.0 (11.3) | 140.0 (11.0) | 140.8 (10.6) | 143.1 (13.3) |
| Diastolic | 87.4 (9.6) | 88.8 (8.8) | 85.3 (9.1) | 85.6 (8.8) | 87.9 (10.5) |
| eGFR, mean (SD), mL/min/1.73 m2 | 81.7 (16.5) | 82.0 (14.5) | 80.2 (18.3) | 81.9 (19.4) | 78.7 (21.0) |
| eGFR ≥60 mL/min/1.73 m2, No. (%) | 68 (87) | 70 (96) | 69 (92) | 68 (90) | 64 (85) |
| Serum angiotensinogen concentration, mean (SD), ng/mL | 22.1 (5.9) | 23.2 (7.8) | 20.8 (4.9) | 21.7 (5.9) | 23.9 (10.9) |
Abbreviation: eGFR, estimated glomerular filtration rate.
All randomized patients who received any amount of study drug. Patients enrolled at sites in Ukraine (n = 16) were excluded from the analysis populations.
Race and ethnicity were self-reported from patient to the investigator in closed categories. For ethnicity, categories were Hispanic or Latino, not Hispanic or Latino, not reported, or unknown. For race, categories were American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, other (please specify), or not reported.
Patients who met the study inclusion criteria with at least 1 of the following: medical history of type 2 diabetes, glycated hemoglobin A1c >7% before first study drug dose, or taking diabetes medication before first study drug dose.
Safety analysis set included all patients who received any amount of study drug, grouped according to the treatment actually received.