Table 1.
Patient Disposition and Characteristics
| Single-Dose Study | Multiple-Dose Study | |||||
|---|---|---|---|---|---|---|
| Deltoid (n= 18) | Gluteal (n = 19) | Total (n = 37) | Deltoid/Deltoid (n = 73) | Gluteal/Deltoid (n = 68) | Total (n = 141) | |
| Patient disposition, n | ||||||
| Screened | 52 | 204 | ||||
| Enrolled and randomized | 18 | 19 | 37 | 73 | 68 | 141 |
| Treated | 17 | 18 | 35 | 71 | 67 | 138 |
| Completed,a n (%) | 16 (88.9) | 14 (73.7) | 30 (81.1) | 50 (68.5) | 46 (67.6) | 96 (68.1) |
| Discontinued, n (%) | 2 (11.1) | 5 (26.3) | 7 (18.9) | 23 (31.5) | 22 (32.4) | 45 (31.9) |
| Lost to follow-up | 0 | 3 (15.8) | 3 (8.1) | 7 (9.6) | 5 (7.4) | 12 (8.5) |
| Adverse eventb | 0 | 0 | 0 | 4 (5.5) | 3 (4.4) | 7 (5.0) |
| Patient met withdrawal criteria | 0 | 0 | 0 | 3 (4.1) | 0 | 3 (2.1) |
| Investigator withdrew patient | 1 (5.6) | 2 (10.5) | 3 (8.1) | 0 | 2 (2.9) | 2 (1.4) |
| Patient withdrew consent | 1 (5.6) | 0 | 1 (2.7) | 9 (12.3) | 11 (16.2) | 20 (14.2) |
| Lack of efficacy | 0 | 0 | 0 | 0 | 1 (1.5) | 1 (0.7) |
| Demographics and baseline characteristics | ||||||
| Age, mean (SD), y | 43.1 (11.0) | 45.9 (7.3) | 44.5 (9.3) | 44.3 (9.6) | 43.5 (10.9) | 43.9 (10.2) |
| BMI, mean (SD), mg/kg2 | 27.6 (4.2) | 27.6 (4.7) | 27.6 (4.4) | 27.8 (4.4) | 28.3 (4.5) | 28.0 (4.4) |
| Men, n (%) | 12 (67.0) | 15 (79.0) | 27 (73.0) | 54 (74.0) | 55 (80.9) | 109 (77.3) |
| Race/ethnicity, n (%) | ||||||
| White | 5 (28.0) | 7 (37.0) | 12 (32.0) | 15 (20.5) | 16 (23.5) | 31 (22.0) |
| Black | 13 (72.0) | 12 (63.0) | 25 (68.0) | 57 (78.1) | 50 (73.5) | 107 (75.9) |
| Asian | 0 | 0 | 0 | 1 (1.4) | 1 (1.5) | 2 (1.4) |
| Native Hawaiian/Other Pacific Islander | 0 | 0 | 0 | 0 | 1 (1.5) | 1 (0.7) |
| Hispanic or Latino | 2 (11.0) | 1 (5.0) | 3 (8.0) | 4 (5.5) | 6 (8.8) | 10 (7.1) |
Abbreviation: BMI, body mass index.
a In the single-dose study, patients who completed the day 126 visit were defined as completers. In the multiple-dose study, patients who completed the day 141 visit were defined as completers.b In the multiple-dose study, 7 of 138 patients (5.1%) experienced a treatment-emergent AE that led to study discontinuation (4 in the deltoid/deltoid group, including 1 each with agitation, akathisia, psychotic disorder, and schizophrenia, and 3 in the gluteal/deltoid group, including 1 each with akathisia and psychotic disorder, and 1 patient with decreased weight, apathy, and decreased appetite. Percentages are based on the number of randomized patients.