Table 2.
Baseline demographic and clinical characteristics, safety analysis set
| NB (n = 2545) | Placebo (n = 1515) | |
|---|---|---|
| Mean (SD) age, y | 45.9(11.2) | 45.3 (11.4) |
| Age 18–44 y, n (%) | 1113(43.7) | 686 (45.3) |
| Age 45–64 y, n (%) | 1376 (54.1) | 797 (52.6) |
| Age ≥ 65 y, n (%) | 56 (2.2) | 32 (2.1) |
| Sex, n (%) | ||
| Male | 447 (17.6) | 268 (17.7) |
| Female | 2098 (82.4) | 1247 (82.3) |
| Race, n (%) | ||
| White | 1974 (77.6) | 1193 (78.7) |
| Black | 453 (17.8) | 261 (17.2) |
| Asian | 30 (1.2) | 15 (1.0) |
| Native Hawaiian or other Pacific Islander | 10 (0.4) | 5 (0.3) |
| American Indian or Alaska Native | 37 (1.5) | 22 (1.5) |
| Other | 41 (1.6) | 19 (1.3) |
| Mean (SD) BMI, kg/m2 | 36.2 (4.4) | 36.2 (4.1) |
| BMI ≥ 30–<35, n (%) | 960 (37.7) | 547 (36.1) |
| BMI ≥ 35–<40, n (%) | 876 (34.4) | 596 (39.3) |
| BMI ≥ 40, n (%) | 640 (25.1) | 341 (22.5) |
| Hypertension, n (%) | 646 (25.4) | 367 (24.2) |
| Dyslipidemia, n (%) | 1416 (55.6) | 801 (52.9) |
| Type 2 diabetes, n (%) | 333 (13.1) | 169(11.2) |
| Complicated obesity, n (%)a | 1596 (62.7) | 991 (60.1) |
| History of anxiety, n (%) | 103 (4.0) | 63 (4.2) |
| History of depression, n (%) | 305 (12.0) | 193 (12.7) |
| Mean (SD) IDS-SR scoreb | 6.9 (5.59) | 6.6 (5.27) |
| No depression (IDS-SR score ≤ 13), n (%) | 1907 (88.0) | 1188 (89.0) |
| Mild depression (IDS-SR score 14–25), n (%) | 244 (11.3) | 138 (10.3) |
| Moderate depression (IDS-SR score 26–38), n (%) | 16 (0.7) | 8 (0.6) |
| Severe depression (IDS-SR score 39–48), n (%) | 1 (0.05) | 1 (0.07) |
| Tobacco use, n (%) | 209 (8.2) | 131 (8.6) |
| Alcohol use, n (%) | 1080 (42.4) | 661 (43.6) |
All data are presented as n (%) unless otherwise noted
BMI body mass index, IDS-SR Inventory of Depressive Symptomatology, Subject-Rated, NB 32 mg naltrexone PR plus 360 mg bupropion PR (or 32 mg naltrexone immediate release plus 400 mg bupropion PR in study NB-201), PR prolonged release
Complicated obesity was defined as BMI of ≥27 to ≤45 kg/m2 with controlled hypertension and/or dyslipidemia
IDS-SR was not assessed in the phase 2 study (NB-201); NB, n = 2168; placebo, n = 1335. The 6 NB-treated (0.02%) and 2 placebo-treated (0.01%) subjects with baseline IDS-SR scores > 30 were eligible for participation in the phase 3 studies because their scores had been <30 at screening visits