Demographics and baseline characteristics
| Patients meeting the criteria for pre-diabetes | |||||
| Characteristics, mean (SD) | Efpeglenatide | Placebo (n=30) | |||
| 4 mg QW (n=28) | 6 mg QW (n=26) | 6 mg Q2W (n=32) | 8 mg Q2W (n=24) | ||
| Female, n (%) | 18 (64.3) | 20 (76.9) | 23 (71.9) | 22 (91.7) | 23 (76.7) |
| Male, n (%) | 10 (35.7) | 6 (23.1) | 9 (28.1) | 2 (8.3) | 7 (23.3) |
| Race, n (%) | |||||
| White | 21 (75.0) | 13 (50.0) | 25 (78.1) | 17 (70.8) | 17 (56.7) |
| Black or African American | 5 (17.9) | 6 (23.1) | 4 (12.5) | 3 (12.5) | 9 (30.0) |
| Asian | 1 (3.6) | 6 (23.1) | 2 (6.3) | 4 (16.7) | 3 (10.0) |
| Native Hawaiian or other Pacific Islander | 1 (3.6) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Other | 0 (0) | 1 (3.8) | 1 (3.1) | 0 (0) | 1 (3.3) |
| Ethnicity, n (%) | |||||
| Hispanic or Latino | 3 (10.7) | 3 (11.5) | 2 (6.3) | 2 (8.3) | 3 (10.0) |
| Not Hispanic or Latino | 25 (89.3) | 23 (88.5) | 30 (93.8) | 22 (91.7) | 27 (90.0) |
| Age, years | 45.6 (11.0) | 46.2 (12.2) | 48.5 (10.9) | 47.5 (9.3) | 45.0 (11.3) |
| Weight, kg | 104.9 (22.0) | 104.5 (23.3) | 100.9 (19.5) | 94.5 (11.3) | 96.9 (10.9) |
| BMI, kg/m2 | 35.9 (4.7) | 36.8 (5.0) | 35.9 (5.6) | 34.8 (3.3) | 35.1 (3.1) |
| Waist circumference, cm | 112.0 (13.1) | 113.4 (14.8) | 113.0 (12.6) | 108.7 (10.4) | 109.7 (9.8) |
| HbA1c, % | 5.7 (0.3) | 5.7 (0.3) | 5.7 (0.3) | 5.7 (0.3) | 5.7 (0.4) |
| HbA1c, mmol/mol | 38.6 (3.1) | 38.3 (3.2) | 38.9 (2.8) | 39.1 (3.2) | 38.8 (4.0) |
| FPG, mg/dL | 100.3 (9.9) | 101.7 (9.6) | 103.4 (10.0) | 103.3 (8.5) | 102.3 (12.0) |
| Total cholesterol, mg/dL | 185.1 (29.3) | 183.2 (36.2) | 193.2 (32.2) | 192.4 (27.8) | 180.3 (28.3) |
| BALANCE 205 full analysis set | 4 mg QW (n=59) | 6 mg QW (n=59) | 6 mg Q2W (n=59) | 8 mg Q2W (n=58) | Placebo (n=60) |
| Mean age, years (range) | 42.9 (20–64) | 43.0 (18–64) | 43.3 (20–64) | 43.9 (27–64) | 43.7 (18–64) |
| < median, n | 28 | 31 | 28 | 28 | 28 |
| ≥ median, n | 31 | 28 | 31 | 30 | 32 |
| Female, n (%) | 41 (69.5) | 46 (78.0) | 43 (72.9) | 51 (87.9) | 44 (73.3) |
| Race, n (%) | |||||
| White | 41 (69.5) | 37 (62.7) | 45 (76.3) | 39 (67.2) | 39 (65.0) |
| Black or African American | 12 (20.3) | 11 (18.6) | 8 (13.6) | 13 (22.4) | 16 (26.7) |
| Asian | 4 (6.8) | 8 (13.6) | 5 (8.5) | 5 (8.6) | 3 (5.0) |
| American Indian or Alaska Native | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.7) |
| Native Hawaiian or other Pacific Islander | 1 (1.7) | 0 (0) | 0 (0) | 1 (1.7) | 0 (0) |
| Other | 0 (0) | 2 (3.4) | 1 (1.7) | 0 (0) | 1 (1.7) |
| Multiple: White, Black, or African American | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Ethnicity, n (%) | |||||
| Hispanic or Latino | 4 (6.8) | 10 (16.9) | 7 (11.9) | 6 (10.3) | 7 (11.7) |
| Not Hispanic or Latino | 55 (93.2) | 49 (83.1) | 52 (88.1) | 52 (89.7) | 53 (88.3) |
| Mean HbA1c, % (range) | 5.5 (4.6–6.2) | 5.4 (4.6–6.5) | 5.5 (4.9–6.1) | 5.4 (4.5–6.2) | 5.5 (4.4–6.5) |
| Mean HbA1c, mmol/mol (range) | 36.1 (26.8–44.3) | 35.3 (26.8–47.5) | 36.9 (30.1–43.2) | 35.9 (25.7–44.3) | 36.4 (24.6–47.5) |
| Mean weight, kg (range) | 100.8 (71.6–191.0) | 101.7 (64.4–157.3) | 99.5 (71.4–161.0) | 95.6 (73.1–138.3) | 97.5 (67.0–130.0) |
| Mean BMI, kg/m2 (range) | 35.2 (28.3–53.1) | 36.3 (28.1–49.7) | 35.6 (28.1–57.7) | 35.2 (28.6–45.2) | 34.9 (28.2–41.7) |
| < median, n | 32 | 23 | 28 | 32 | 31 |
| ≥ median, n | 27 | 36 | 31 | 26 | 29 |
| Mean waist circumference (range) | 109.8 (87.4–154.5) | 111.9 (86.0–147.3) | 109.6 (89.0–141.0) | 108.9 (85.0–134.5) | 109.3 (83.0–134.0) |
BMI, body mass index; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; Q2W, once every 2 weeks; QW, once weekly.