Table 2.
Treatment effects at week 21 (full analysis set)
| Efficacy endpoint | Placebo n = 60 | Efpeglenatide 4 mg once weekly n = 59 | Efpeglenatide 6 mg once weekly n = 59 | Efpeglenatide 6 mg once every 2 wk n = 59 | Efpeglenatide 8 mg once every 2 wk n = 58 |
|---|---|---|---|---|---|
| Body weight, kg | |||||
| Baseline | 97.5 (12.1) | 100.8 (19.3) | 101.7 (19.4) | 99.5 (18.4) | 95.6 (13.3) |
| Week 21 | 97.9 (12.2) | 93.6 (15.7) | 91.3 (16.3) | 93.2 (19.9) | 86.1 (12.6) |
| LSM (SE) change from baselinea | −0.1 (0.6) | −6.6 (0.6) | −7.3 (0.6) | −6.4 (0.6) | −7.1 (0.6) |
| n | 48 | 44 | 42 | 41 | 40 |
| LSM difference vs. placeboa (95.1% CI) | ‐ | −6.5 (−8.2, −4.8) | −7.2 (−8.9, −5.5) | −6.3 (−8.0, −4.6) | −6.9 (−8.7, −5.2) |
| P | ‐ | < 0.0001 | < 0.0001 | < 0.0001 | < 0.0001 |
| Body weight, per cent change | |||||
| LSM (SE) per cent change from baselinea | 0.1 (0.6) | −6.7 (0.6) | −7.3 (0.6) | −6.7 (0.6) | −7.4 (0.6) |
| LSM difference vs. placeboa (95.1% CI) | ‐ | −6.8 (−8.4, −5.1) | −7.4 (−9.1, −5.7) | −6.7 (−8.4, −5.1) | −7.5 (−9.2, −5.8) |
| P | ‐ | < 0.0001 | < 0.0001 | < 0.0001 | < 0.0001 |
| BMI, kg/m2 | |||||
| Baseline | 34.9 (3.2) | 35.2 (4.5) | 36.3 (4.4) | 35.6 (4.8) | 35.2 (3.9) |
| Week 21 | 34.8 (3.5) | 32.7 (3.8) | 33.0 (3.6) | 33.4 (5.5) | 32.0 (3.8) |
| LSM (SE) change from baselinea | 0.0 (0.2) | −2.4 (0.2) | −2.6 (0.2) | −2.3 (0.2) | −2.6 (0.2) |
| n | 48 | 44 | 42 | 41 | 40 |
| LSM difference vs. placeboa (95.1% CI) | ‐ | −2.4 (−3.0, −1.8) | −2.6 (−3.2, −2.0) | −2.3 (−2.9, −1.7) | −2.6 (−3.2, −2.0) |
| P | ‐ | < 0.0001 | < 0.0001 | < 0.0001 | < 0.0001 |
| Waist circumference, cm | |||||
| Baseline | 109.3 (10.7) | 109.8 (12.2) | 111.9 (13.3) | 109.6 (11.8) | 108.9 (10.9) |
| Week 21 | 108.7 (10.3) | 104.1 (12.0) | 103.9 (11.4) | 103.0 (13.2) | 99.3 (10.0) |
| LSM (SE) change from baselinea | −0.9 (1.0) | −5.2 (1.0) | −6.7 (1.0) | −6.2 (1.0) | −8.3 (1.0) |
| n | 47 | 44 | 42 | 41 | 40 |
| LSM difference vs. placeboa (95.1% CI) | ‐ | −4.4 (−7.1, −1.6) | −5.9 (−8.6, −3.1) | −5.3 (−8.1, −2.5) | −7.5 (−10.3, −4.7) |
| P | ‐ | 0.0018 | < 0.0001 | < 0.0001 | < 0.0001 |
Data are mean (SD), unless otherwise stated.
Week 21 values correspond to 20 wk of treatment.
LSM difference vs. placebo is calculated as the study dose group – placebo in LSM change from baseline to week 21.
Abbreviations: CI, confidence interval; LSM, least squares mean; MMRM, mixed‐effect model with repeated measures.
a
From MMRM, using an unstructured covariance matrix; change from baseline as the outcome variable; baseline as a covariate; treatment group, visit and their interaction as factors.