Table 4.
Baseline Values, Observed Change from Baseline to Week 34 (a) and Week 86 (b) in DXA-Derived Body Composition Measures, and Adjusted Between-Group Differences (Full Analysis Set)
| a) Main period: patients treated with once-weekly somapacitan, once-weekly placebo or daily GH | |||||
|---|---|---|---|---|---|
| Somapacitan observed mean (SD) | Daily GH observed mean (SD) | Placebo Observed mean (SD) | Adjusted between-group difference (95% CI)a Somapacitan—placebo | Adjusted between-group difference (95% CI)a Somapacitan—daily GH | |
| Effects on fat mass | |||||
| Truncal fat percentage, % | |||||
| Baseline | 39.11 (8.81) | 38.10 (9.65) | 36.90 (8.98) | ||
| Change to week 34 | –1.16 (2.91) | –2.47 (4.54) | +0.63 (3.17) | –1.53 (–2.68, –0.38); P = 0.0090 | +1.17 (0.23; 2.11)b |
| Percentage change in visceral fatc | |||||
| Baseline | 100.0 | 100.0 | 100.0 | ||
| Change to week 34 | –9.41 (22.11) | –8.31 (25.46) | +6.30 (18.04) | –15.7 (–23.4; –8.0); P < 0.0001 | –1.7 (–8.0; 4.5); P = 0.5817 |
| Total fat mass, kg | |||||
| Baseline | 27.56 (10.80) | 27.26 (11.97) | 24.82 (11.36) | ||
| Change to week 34 | –0.08 (3.05) | –0.81 (3.15) | +0.39 (2.53) | –0.27 (–1.20, 0.66); P = 0.5746 | +0.72 (–0.04; 1.49); P = 0.0629 |
| Truncal fat mass, kg | |||||
| Baseline | 14.78 (6.27) | 14.12 (6.32) | 12.67 (6.01) | ||
| Change to week 34 | –0.18 (1.78) | –0.61 (1.89) | +0.48 (1.42) | –0.50 (–1.05; –0.06); P = 0.0786 | +0.41 (–0.04; 0.86); P = 0.0749 |
| Gynoid fat mass, kg | |||||
| Baseline | 4.21 (1.67) | 4.21 (1.83) | 4.08 (2.17) | ||
| Change to week 34 | +0.02 (0.51) | –0.12 (0.47) | +0.01 (0.55) | +0.02 (–0.14; 0.17); P = 0.8511 | +0.15 (0.02; 0.28); P = 0.0276 |
| Android fat mass, kg | |||||
| Baseline | 24.80 (1.22) | 23.95 (1.23) | 20.89 (1.11) | ||
| Change to week 34 | –0.08 (0.36) | –0.15 (0.32) | +0.06 (0.27) | –0.12 (–0.22; –0.01); P = 0.0326 | +0.07 (–0.01; 0.16); P = 0.0923 |
| Effects on lean mass | |||||
| Total lean body mass, kg | |||||
| Baseline | 45.48 (13.11) | 45.66 (14.32) | 42.53 (11.01) | ||
| Change to week 34 | +1.38 (2.12) | +1.44 (2.29) | +0.31 (2.09) | 1.14 (0.46, 1.83); P = 0.0011 | 0.05 (–0.51; 0.61); P = 0.8653 |
| Truncal lean body mass, kg | |||||
| Baseline | 22.30 (6.64) | 22.46 (7.34) | 20.70 (5.57) | ||
| Change to week 34 | +0.79 (1.37) | +0.89 (1.35) | +0.41 (1.26) | 0.45 (0.03, 0.88); P = 0.0380 | –0.04 (–0.39; 0.31); P = 0.8295 |
| Appendicular skeletal muscle mass, kg | |||||
| Baseline | 20.30 (6.58) | 20.35 (7.02) | 18.96 (5.49) | ||
| Change to week 34 | +0.56 (1.01) | +0.51 (1.25) | –0.12 (1.01) | 0.68 (0.34, 1.02); P = 0.0001 | 0.10 (–0.18; 0.37); P = 0.4996 |
| b) Extension period: patients treated with somapacitan/somapacitan versus daily GH/daily GH. Note that baseline refers to the beginning of the trial and not to week 34 | |||||
| Somapacitan/ somapacitan Observed mean (SD) | Daily GH/daily GH Observed mean (SD) | Placebo/ somapacitan Observed mean (SD) | Daily GH/ somapacitan Observed mean (SD) | Adjusted between-group difference at week 86 (95% CI) d Somapacitan/ somapacitan – Daily GH/daily GH | |
| Effects on fat mass | |||||
| Truncal fat percentage, % | |||||
| Baseline | 39.12 (8.81) | 38.16 (9.46) | 37.00 (8.89) | 38.26 (9.59) | |
| Change to week 86 | –1.68 (3.64) | –2.77 (4.69) | –2.16 (3.94) | –0.96 (4.51) | 1.15 (–0.10;2.40); P = 0.0715 |
| Percentage change in visceral fatc | |||||
| Baseline | 100.00 | 100.00 | 100.00 | 100.00 | |
| Change to week 86 | –5.41 (28.29) | –5.84 (28.66) | –16.09 (35.20) | –0.88 (38.42) | 2.16 (–9.68;13.99); P = 0.7197 |
| Total fat mass, kg | |||||
| Baseline | 27.56 (10.80) | 27.97 (11.89) | 24.86 (11.34) | 26.82 (12.01) | |
| Change to week 86 | –0.20 (3.72) | –1.01 (4.14) | –0.54 (3.25) | +0.88 (4.79) | 0.98 (–0.25;2.21); P = 0.1176 |
| Truncal fat mass, kg | |||||
| Baseline | 14.78 (6.27) | 14.50 (6.23) | 12.72 (6.00) | 14.00 (6.68) | |
| Change to week 86 | –0.25 (2.22) | –0.76 (2.27) | –0.31 (1.77) | +0.36 (2.55) | 0. 61 (–0.09; 1.30); P = 0.0876 |
| Gynoid fat mass, kg | |||||
| Baseline | 4.21 (1.66) | 4.30 (1.86) | 4.05 (2.16) | 4.17 (1.81) | |
| Change to week 86 | +0.003 (0.56) | –0.12 (0.63) | –0.09 (0.76) | +0.14 (0.79) | 0.14 (–0.07; 0.35); P = 0.1839 |
| Android fat mass, kg | |||||
| Baseline | 2.48 (1.22) | 2.43 (1.16) | 2.09 (1.10) | 2.40 (1.30) | |
| Change to week 86 | –0.05 (0.47) | –0.12 (0.38) | –0.11 (0.37) | +0.01 (0.49) | 0.10 (–0.04; 0.24); P = 0.1679 |
| Effects on lean mass | |||||
| Total lean body mass, kg | |||||
| Baseline | 45.48 (13.11) | 46.14 (12.75) | 42.49 (10.97) | 44.68 (15.21) | |
| Change to week 86 | 1.73 (2.53) | 1.50 (2.48) | 1.72 (2.97) | 1.68 (3.41) | 0.43 (–0.40;1.27); P = 0.3092 |
| Truncal lean body mass, kg | |||||
| Baseline | 22.29 (6.64) | 22.77 (6.37) | 20.68 (5.55) | 21.97 (7.88) | |
| Change to week 86 | 1.15 (1.49) | 1.00 (1.28) | 1.20 (1.50) | 1.02 (1.55) | 0.27 (–0.18;0.72); P = 0.2421 |
| Appendicular skeletal muscle mass, kg | |||||
| Baseline | 20.31 (6.58) | 20.45 (6.35) | 18.96 (5.49) | 19.99 (7.44) | |
| Change to week 86 | 0.54 (1.23) | 0.48 (1.53) | 0.45 (1.69) | 0.63 (1.93) | 0.10 (–0.36;0.56); P = 0.6778 |
Abbreviations: CI, confidence interval; DXA, dual-energy x-ray absorptiometry
aAdjusted values based on analysis of covariance model. bThis was not designed as a confirmatory test and no hierarchical test strategy was constructed; therefore, no p value was calculated. cPost hoc-defined endpoint. dAdjusted data based on mixed model for repeated measurements. Changes are expressed as a percentage, therefore initial values are 100%.