Table 4. Open in new tab Baseline...

a) Main period: patients treated with once-weekly somapacitan, once-weekly placebo or 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 fat^c
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 fat^c
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

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 fat^c

Baseline

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 fat^c

Baseline

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

a) Main period: patients treated with once-weekly somapacitan, once-weekly placebo or 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 fat^c
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 fat^c
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

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 fat^c

Baseline

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 fat^c

Baseline

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

Table 4.

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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 fat^c
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 fat^c
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

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 fat^c
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 fat^c
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%.

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