REAL 1: Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02229851
• Collaborator: (none)
• Enrollment: 301
• Locations: 117
• Arms: 3
• Actual Duration (Months): 42.2
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Disorder; Adult Growth Hormone Deficiency	Drug: somapacitan; Drug: somatropin; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 301 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period
• Actual Study Start Date: Oct 31, 2014
• Actual Primary Completion Date: Apr 21, 2017
• Actual Study Completion Date: May 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0195-0092 (somapacitan)	Drug: somapacitan; Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.; Other Names: NNC0195-0092
Active Comparator: Daily hGH	Drug: somatropin; Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.
Placebo Comparator: Placebo Switch to NNC0195-0092 (somapacitan) treatment in the extension period.	Drug: somapacitan; Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.; Other Names: NNC0195-0092 ; Drug: placebo; Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.

Outcome Measures

Primary Outcome Measures

1. Change in Truncal Fat Percentage (Week 34) [Week -3, week 34]

   Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).

Secondary Outcome Measures

1. Change in Truncal Fat Percentage (Week 87) [week -3, week 87]

   Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).

2. Change in Truncal Fat Mass (Week 34) [Week -3, week 34]

   Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

3. Change in Truncal Fat Mass (Week 87) [week -3, week 87]

   Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

4. Change in Truncal Lean Body Mass (Week 34) [Week -3, week 34]

   Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

5. Change in Truncal Lean Body Mass (Week 87) [week -3, week 87]

   Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

6. Change in Total Fat Mass (Week 34) [Week -3, week 34]

   Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

7. Change in Total Fat Mass (Week 87) [Week -3, week 87]

   Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

8. Change in Visceral Adipose Tissue (Week 34) [Week -3, week 34]

   Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).

9. Change in Visceral Adipose Tissue (Week 87) [Week -3, week 87]

   Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).

10. Change in Android Fat Mass (Week 34) [Week -3, week 34]

    Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

11. Change in Android Fat Mass (Week 87) [week -3, week 87]

    Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

12. Change in Gynoid Fat Mass (Week 34) [Week -3, week 34]

    Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

13. Change in Gynoid Fat Mass (Week 87) [week -3, week 87]

    Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

14. Change in Appendicular Skeletal Muscle Mass (Week 34) [Week -3, week 34]

    Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

15. Change in Appendicular Skeletal Muscle Mass (Week 87) [week -3, week 87]

    Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

16. Change in Lean Body Mass (Week 34) [Week -3, week 34]

    Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

17. Change in Lean Body Mass (Week 87) [week -3, week 87]

    Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

18. Change in Bone Mineral Content (Week 87) [week -3, week 87]

    Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).

19. Change in Bone Mineral Density (Week 87) [week -3, week 87]

    Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).

20. Change in IGF-I SDS (Week 34) [Week -3, week 34]

    Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.

21. Change in IGF-I SDS (Week 87) [Week -3, week 87]

    Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.

22. Change in IGFBP 3 SDS (Week 34) [Week -3, week 34]

    Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).

23. Change in IGFBP 3 SDS (Week 87) [Week -3, week 87]

    Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).

24. Change in TRIM-AGHD (Total and Domain Scores) (Week 34) [Week 0, week 34]

    Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.

25. Change in TRIM-AGHD (Total and Domain Scores) (Week 87) [week 0, week 87]

    Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.

26. Change in SF-36v2 (Summary and Domain Scores) (Week 34) [Week 0, week 34]

    SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.

27. Change in SF-36v2 (Summary and Domain Scores) (Week 87) [week 0, week 87]

    SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.

28. TSQM-9 Scores (Domain Scores) (Week 34) [Week 34]

    Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.

29. TSQM-9 Scores (Domain Scores) (Week 87) [Week 87]

    Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.

30. Change in Total Cholesterol (Week 34) [Week -3, week 34]

    Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

31. Change in Total Cholesterol (Week 87) [week -3, week 87]

    Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

32. Change in HDL-cholesterol (Week 34) [Week -3, week 34]

    Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

33. Change in HDL-cholesterol (Week 87) [week -3, week 87]

    Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

34. Change in LDL-cholesterol (Week 34) [Week -3, week 34]

    Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

35. Change in LDL-cholesterol (Week 87) [week -3, week 87]

    Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

36. Change in Triglycerides (Week 34) [Week -3, week 34]

    Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).

37. Change in Triglycerides (Week 87) [week -3, week 87]

    Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).

38. Change in Hs-CRP (Week 34) [Week -3, week 34]

    Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

39. Change in Hs-CRP (Week 87) [week -3, week 87]

    Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).

40. Change in IL-6 (Week 34) [Week -3, week 34]

    Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).

41. Change in IL-6 (Week 87) [week -3, week 87]

    Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).

42. Change in Body Weight (Week 34) [Week -3, week 34]

    Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).

43. Change in Body Weight (Week 87) [week -3, week 87]

    Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).

44. Change in Waist Circumference (Week 34) [Week -3, week 34]

    Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).

45. Change in Waist Circumference (Week 87) [week -3, week 87]

    Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).

46. Number of Adverse Events (Weeks 0-35) [Weeks 0-35]

    Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.

47. Number of Adverse Events (Weeks 0-88) [Weeks 0-88]

    Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.

48. Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) [Weeks 0 to 35]

    Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

49. Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) [Weeks 0 to 88]

    Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

50. Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) [Weeks 0 to 35]

    Incidence of technical complaints were recorded from baseline (week 0) until week 35.

51. Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) [Weeks 0 to 88]

    Incidence of technical complaints were recorded from baseline (week 0) until week 88.

52. Change in Physical Examination During Exposure to Trial Product (Week 35) [Week 0 and week 35]

    Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation

53. Change in Physical Examination During Exposure to Trial Product (Week 88) [Week 0 and week 88]

    Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation

54. Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) [Week -3 and week 35]

    Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.

55. Change in ECG Evaluation During Exposure to Trial Product (Week 88) [Week -3 and week 88]

    Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.

56. Change in Diastolic Blood Pressure (Week 35) [Week -3, week 35]

    Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

57. Change in Diastolic Blood Pressure (Week 88) [Week -3, week 88]

    Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.

58. Change in Systolic Blood Pressure (Week 35) [Week -3, week 35]

    Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

59. Change in Systolic Blood Pressure (Week 88) [Week -3, week 88]

    Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).

60. Change in Pulse (Week 35) [Week -3, week 35]

    Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).

61. Change in Pulse (Week 88) [Week -3, week 88]

    Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).

62. Change in Haemoglobin (Week 34) [Week -3, week 34]

    Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).

63. Change in Haemoglobin (Week 87) [week -3, week 87]

    Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.

64. Change in Haematocrit (Week 34) [Week -3, week 34]

    Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).

65. Change in Haematocrit (Week 87) [week -3, week 87]

    Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.

66. Change in Erythrocytes (Week 34) [Week -3, week 34]

    Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

67. Change in Erythrocytes (Week 87) [week -3, week 87]

    Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.

68. Change in Mean Corpuscular Volume (MCV) (Week 34) [Week -3, week 34]

    Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).

69. Change in Mean Corpuscular Volume (MCV) (Week 87) [week -3, week 87]

    Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.

70. Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34) [Week -3, week 34]

    Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).

71. Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) [week -3, week 87]

    Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.

72. Change in Thrombocytes (Week 34) [Week -3, week 34]

    Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

73. Change in Thrombocytes (Week 87) [week -3, week 87]

    Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.

74. Change in Leucocytes (Week 34) [Week -3, week 34]

    Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

75. Change in Leucocytes (Week 87) [week -3, week 87]

    Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.

76. Change in Alanine Aminotransferase (ALT) (Week 34) [Week -3, week 34]

    Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).

77. Change in Alanine Aminotransferase (ALT) (Week 87) [week -3, week 87]

    Change in ALT was measured from baseline (week -3) until the end of the week 87.

78. Change in Albumin (Week 34) [Week -3, week 34]

    Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).

79. Change in Albumin (Week 87) [week -3, week 87]

    Change in Albumin was measured from baseline (week -3) until the end of the week 87.

80. Change in Alkaline Phosphatase (ALP) (Week 34) [Week -3, week 34]

    Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

81. Change in Alkaline Phosphatase (AP) (Week 87) [Week -3, week 87]

    Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.

82. Change in Aspartate Aminotransferase (AST) (Week 34) [Week -3, week 34]

    Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).

83. Change in Aspartate Aminotransferase (AST) (Week 87) [Week -3, week 87]

    Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).

84. Change in Bilirubin (Week 34) [Week -3, week 34]

    Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).

85. Change in Bilirubin (Week 87) [week -3, week 87]

    Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

86. Change in Calcium (Week 34) [Week -3, week 34]

    Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).

87. Change in Calcium (Week 87) [week -3, week 87]

    Change in Calcium was measured from baseline (week -3) until the end of the week 87.

88. Change in Chloride (Week 34) [Week -3, week 34]

    Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).

89. Change in Chloride (Week 87) [week -3, week 87]

    Change in Chloride was measured from baseline (week -3) until the end of the week 87.

90. Change in Creatinine (Week 34) [Week -3, week 34]

    Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).

91. Change in Creatinine (Week 87) [week -3, week 87]

    Change in Creatinine was measured from baseline (week -3) until the end of the week 87.

92. Change in Creatine Kinase (Week 34) [Week -3, week 34]

    Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).

93. Change in Creatine Kinase (Week 87) [week -3, week 87]

    Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.

94. Change in Gamma-glutamyl Transferase (GGT) (Week 34) [Week -3, week 34]

    Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).

95. Change in Gamma-glutamyl Transferase (GGT) (Week 87) [week -3, week 87]

    Change in GGT was measured from baseline (week -3) until the end of the week 87.

96. Change in Phosphate (Inorganic) (Week 34) [Week -3, week 34]

    Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).

97. Change in Phosphate (Inorganic)(Week 87) [week -3, week 87]

    Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.

98. Change in Potassium (Week 34) [Week -3, week 34]

    Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).

99. Change in Potassium (Week 87) [week -3, week 87]

    Change in Potassium was measured from baseline (week -3) until the end of the week 87.

100. Change in Sodium (Week 34) [Week -3, week 34]

     Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).

101. Change in Sodium (Week 87) [week -3, week 87]

     Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).

102. Change in Total Protein (Week 34) [Week -3, week 34]

     Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).

103. Change in Total Protein (Week 87) [week -3, week 87]

     Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).

104. Change in Urea (Week 34) [Week -3, week 34]

     Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).

105. Change in Urea (Week 87) [week -3, week 87]

     Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).

106. Change in Uric Acid (Week 34) [Week -3, week 34]

     Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).

107. Change in Uric Acid (Week 87) [week -3, week 87]

     Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).

108. Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34) [Week -3, week 34]

     Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).

109. Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) [week -3, week 87]

     Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

110. Change in Fasting Plasma Glucose (Week 34) [Week -3, week 34]

     Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).

111. Change in Fasting Plasma Glucose (Week 87) [week -3, week 87]

     Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).

112. Change in Fasting Insulin (Week 34) [Week -3, week 34]

     Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).

113. Change in Fasting Insulin (Week 87) [week -3, week 87]

     Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

114. Change in Steady State Beta Cell Function (%B) (Week 34) [Week -3, week 34]

     Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).

115. Change in Steady State Beta Cell Function (%B) (Week 87) [week -3, week 87]

     Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.

116. Change in Insulin Resistance (IR %) (Week 34) [Week -3, week 34]

     Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).

117. Change in Insulin Resistance (IR %) (Week 87) [week -3, week 87]

     Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

118. Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) [Week -3, week 34]

     Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).

119. Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) [week -3, week 87]

     Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent

• Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included)

• If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator

• FOR ALL COUNTRIES EXCEPT JAPAN:

Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test):

1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)

2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m^{2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m}2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m^2, a peak GH less than 4 ng/mL (4 mcg/L)

3. Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):

1. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)

Exclusion Criteria:

• Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin

• Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35233
2	Novo Nordisk Investigational Site	Los Angeles	California	United States	90033
3	Novo Nordisk Investigational Site	Los Angeles	California	United States	90095
4	Novo Nordisk Investigational Site	Aurora	Colorado	United States	80045
5	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30318
6	Novo Nordisk Investigational Site	Roswell	Georgia	United States	30076
7	Novo Nordisk Investigational Site	Topeka	Kansas	United States	66606
8	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21205
9	Novo Nordisk Investigational Site	Boston	Massachusetts	United States	02114
10	Novo Nordisk Investigational Site	East Lansing	Michigan	United States	48824
11	Novo Nordisk Investigational Site	Saint Louis	Missouri	United States	63110
12	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68105
13	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68198-4120
14	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89128
15	Novo Nordisk Investigational Site	Reno	Nevada	United States	89511
16	Novo Nordisk Investigational Site	New York	New York	United States	10032
17	Novo Nordisk Investigational Site	Cleveland	Ohio	United States	44195
18	Novo Nordisk Investigational Site	Portland	Oregon	United States	97239
19	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104
20	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19107
21	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15212
22	Novo Nordisk Investigational Site	El Paso	Texas	United States	79935
23	Novo Nordisk Investigational Site	Houston	Texas	United States	77030
24	Novo Nordisk Investigational Site	Plano	Texas	United States	75093
25	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78229
26	Novo Nordisk Investigational Site	Shavano Park	Texas	United States	78231
27	Novo Nordisk Investigational Site	Salt Lake City	Utah	United States	84103
28	Novo Nordisk Investigational Site	Federal Way	Washington	United States	98003
29	Novo Nordisk Investigational Site	Seattle	Washington	United States	98122-5789
30	Novo Nordisk Investigational Site	Blacktown	New South Wales	Australia	2148
31	Novo Nordisk Investigational Site	Coffs Harbour	New South Wales	Australia	2450
32	Novo Nordisk Investigational Site	Darlinghurst	New South Wales	Australia	2010
33	Novo Nordisk Investigational Site	St Leonards	New South Wales	Australia	2065
34	Novo Nordisk Investigational Site	Woolloongabba	Queensland	Australia	4102
35	Novo Nordisk Investigational Site	Box Hill	Victoria	Australia	3128
36	Novo Nordisk Investigational Site	Parkville	Victoria	Australia	3052
37	Novo Nordisk Investigational Site	Nedlands	Western Australia	Australia	6009
38	Novo Nordisk Investigational Site	São Paulo	Sao Paulo	Brazil	01228-000
39	Novo Nordisk Investigational Site	Aachen		Germany	52074
40	Novo Nordisk Investigational Site	Berlin		Germany	10117
41	Novo Nordisk Investigational Site	Berlin		Germany	13352
42	Novo Nordisk Investigational Site	Frankfurt		Germany	60596
43	Novo Nordisk Investigational Site	Oldenburg		Germany	26122
44	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh	India	500034
45	Novo Nordisk Investigational Site	Bangalore	Karnataka	India	560034
46	Novo Nordisk Investigational Site	Kochi	Kerala	India	682041
47	Novo Nordisk Investigational Site	Mumbai	Maharashtra	India	400008
48	Novo Nordisk Investigational Site	New Dehli	New Delhi	India	110029
49	Novo Nordisk Investigational Site	Chandigarh	Punjab	India	160012
50	Novo Nordisk Investigational Site	Hyderabad	Telengana	India	500033
51	Novo Nordisk Investigational Site	Kolkata	West Bengal	India	700032
52	Novo Nordisk Investigational Site	Petah-Tikva		Israel	49100
53	Novo Nordisk Investigational Site	Tel Hashomer		Israel	52621
54	Novo Nordisk Investigational Site	Tel-Aviv		Israel	64239
55	Novo Nordisk Investigational Site	Bunkyo-ku, Tokyo		Japan	113-8603
56	Novo Nordisk Investigational Site	Chiba-shi, Chiba		Japan	260-8677
57	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka		Japan	812-8582
58	Novo Nordisk Investigational Site	Hamamatsu-shi, Shizuoka		Japan	431-3192
59	Novo Nordisk Investigational Site	Itabashi-ku, Tokyo		Japan	173-8606
60	Novo Nordisk Investigational Site	Kagoshima		Japan	890-8520
61	Novo Nordisk Investigational Site	Kyoto-shi Kyoto		Japan	612-8555
62	Novo Nordisk Investigational Site	Minato-ku, Tokyo		Japan	105-8470
63	Novo Nordisk Investigational Site	Okayama, Okayama		Japan	700-8558
64	Novo Nordisk Investigational Site	Sagamihara-shi, Kanagawa		Japan	252-0375
65	Novo Nordisk Investigational Site	Sapporo, Hokkaido		Japan	060-8648
66	Novo Nordisk Investigational Site	Sappro-shi, Hokkaido		Japan	060 8648
67	Novo Nordisk Investigational Site	Tokyo		Japan	134-0088
68	Novo Nordisk Investigational Site	Yamagata-shi, Yamagata		Japan	990-9585
69	Novo Nordisk Investigational Site	Yokohama, Kanagawa		Japan	222-0036
70	Novo Nordisk Investigational Site	Riga		Latvia	LV-1002
71	Novo Nordisk Investigational Site	Kaunas		Lithuania	50009
72	Novo Nordisk Investigational Site	Vilnius		Lithuania	08661
73	Novo Nordisk Investigational Site	Kuching		Malaysia	93586
74	Novo Nordisk Investigational Site	Pulau Pinang		Malaysia	10990
75	Novo Nordisk Investigational Site	Putrajaya		Malaysia	62250
76	Novo Nordisk Investigational Site	Oslo		Norway	0027
77	Novo Nordisk Investigational Site	Bialystok		Poland	15-879
78	Novo Nordisk Investigational Site	Gdansk		Poland	80-952
79	Novo Nordisk Investigational Site	Krakow		Poland	31-455
80	Novo Nordisk Investigational Site	Warszawa		Poland	02-507
81	Novo Nordisk Investigational Site	Warszawa		Poland	04-141
82	Novo Nordisk Investigational Site	Wroclaw		Poland	50-311
83	Novo Nordisk Investigational Site	Wroclaw		Poland	50-367
84	Novo Nordisk Investigational Site	Cluj Napoca	Cluj	Romania	400349
85	Novo Nordisk Investigational Site	Targu Mures	Mures	Romania	540142
86	Novo Nordisk Investigational Site	Bucuresti		Romania	011863
87	Novo Nordisk Investigational Site	Iasi		Romania	700111
88	Novo Nordisk Investigational Site	Sibiu		Romania	550166
89	Novo Nordisk Investigational Site	Timisoara		Romania	300736
90	Novo Nordisk Investigational Site	Kazan		Russian Federation	420061
91	Novo Nordisk Investigational Site	Krasnoyarsk		Russian Federation	660022
92	Novo Nordisk Investigational Site	Moscow		Russian Federation	117036
93	Novo Nordisk Investigational Site	Moscow		Russian Federation	119435
94	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630099
95	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
96	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2013
97	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2193
98	Novo Nordisk Investigational Site	Pretoria	Gauteng	South Africa	0044
99	Novo Nordisk Investigational Site	Tygerberg	Western Cape	South Africa	7505
100	Novo Nordisk Investigational Site	Göteborg		Sweden	413 45
101	Novo Nordisk Investigational Site	Stockholm		Sweden	171 76
102	Novo Nordisk Investigational Site	Uppsala		Sweden	751 85
103	Novo Nordisk Investigational Site	Adana		Turkey	01130
104	Novo Nordisk Investigational Site	Istanbul		Turkey	34098
105	Novo Nordisk Investigational Site	Istanbul		Turkey	34390
106	Novo Nordisk Investigational Site	Izmir		Turkey	35100
107	Novo Nordisk Investigational Site	Kocaeli		Turkey	41380
108	Novo Nordisk Investigational Site	Kiev		Ukraine	01021
109	Novo Nordisk Investigational Site	Kyiv		Ukraine	04114
110	Novo Nordisk Investigational Site	Birmingham		United Kingdom	B15 2TH
111	Novo Nordisk Investigational Site	Coventry		United Kingdom	CV2 2DX
112	Novo Nordisk Investigational Site	Exeter		United Kingdom	EX2 5DW
113	Novo Nordisk Investigational Site	Hull		United Kingdom	HU3 2RW
114	Novo Nordisk Investigational Site	Leeds		United Kingdom	LS9 7TF
115	Novo Nordisk Investigational Site	London		United Kingdom	EC1A 7BE
116	Novo Nordisk Investigational Site	London		United Kingdom	SE5 9RS
117	Novo Nordisk Investigational Site	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure' (1452), Novo Nordisk A/S

Study Documents (Full-Text)

• Study Protocol - Nov 27, 2017
• Statistical Analysis Plan - Nov 27, 2017

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02229851
• Other Study ID Numbers: NN8640-4054; 2013-002892-16; U1111-1145-0211; JapicCTI-152767
• First Posted: Sep 3, 2014
• Last Update Posted: Nov 23, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 92 sites in 16 countries: Australia - 8, Germany - 4, India - 5, Japan - 14, Latvia - 1, Lithuania - 2, Malaysia - 3, Poland - 5, Romania - 5, Russian Fed. - 6, South Africa - 3, Sweden - 1, Turkey - 4, Ukraine - 1, United Kingdom - 4, United States - 26.
Pre-assignment Detail	The trial had a main phase and an extension phase. Participants were treated for 34 weeks in the main phase (followed by 1 week washout) and for 52 weeks in the extension phase (followed by 1 week washout).300 participants received treatment;1 participant was randomised but didn't receive any treatment and was therefore not included in any analyses

Arm/Group Title	Placebo	Norditropin	Somapacitan	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main phase were randomised 1:1 to continue with norditropin or switch to somapacitan. Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main phase were randomised 1:1 to continue with Norditropin or switch to somapacitan. Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Period Title: Main Phase (Double-blind Phase)
STARTED	61	119	120	0	0	0	0
Full Analysis Set	61	119	120	0	0	0	0
Safety Analysis Set	61	119	120	0	0	0	0
COMPLETED	55	103	114	0	0	0	0
NOT COMPLETED	6	16	6	0	0	0	0
Period Title: Main Phase (Double-blind Phase)
STARTED	0	0	0	55	114	52	51
COMPLETED	0	0	0	53	109	47	48
NOT COMPLETED	0	0	0	2	5	5	3

Baseline Characteristics

Arm/Group Title	Placebo	Norditropin	Somapacitan	Total
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants were re-randomised to receive somapacitan while other continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension part of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Total of all reporting groups
Overall Participants	61	119	120	300
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.0 (15.7)	45.7 (15.3)	44.6 (14.3)	45.1 (15.0)
Sex: Female, Male (Count of Participants)
Female	32 52.5%	61 51.3%	62 51.7%	155 51.7%
Male	29 47.5%	58 48.7%	58 48.3%	145 48.3%
Race/Ethnicity, Customized (Count of Participants)
Asian	16 26.2%	36 30.3%	34 28.3%	86 28.7%
Black or African American	2 3.3%	3 2.5%	2 1.7%	7 2.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 0.8%	1 0.3%
White	42 68.9%	76 63.9%	82 68.3%	200 66.7%
Other: Hispanic	1 1.6%	0 0%	1 0.8%	2 0.7%
Other: Hispanic or Latino	0 0%	1 0.8%	0 0%	1 0.3%
Other: Caucasian	0 0%	1 0.8%	0 0%	1 0.3%
Not applicable	0 0%	2 1.7%	0 0%	2 0.7%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	4 6.6%	8 6.7%	6 5%	18 6%
Not Hispanic or Latino	57 93.4%	109 91.6%	114 95%	280 93.3%
Not applicable	0 0%	2 1.7%	0 0%	2 0.7%

Outcome Measures

1. Primary Outcome

Title	Change in Truncal Fat Percentage (Week 34)
Description	Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	111	116
Mean (Standard Deviation) [Percentage of truncal fat]	0.49 (3.31)	-2.39 (4.48)	-1.17 (2.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Somapacitan
	Comments	Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.0090
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-1.53
	Confidence Interval	(2-Sided) 95%; -2.68 to -0.38
	Parameter Dispersion	Type: Value:
	Estimation Comments	Somapacitan-Placebo

2. Secondary Outcome

Title	Change in Truncal Fat Percentage (Week 87)
Description	Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	52	109	48	47
Mean (Standard Deviation) [Percentage of truncal fat]	-2.16 (3.94)	-1.63 (3.65)	-2.63 (4.65)	-0.96 (4.51)

3. Secondary Outcome

Title	Change in Truncal Fat Mass (Week 34)
Description	Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	111	116
Mean (Standard Deviation) [grams]	417.86 (1536.36)	-619.67 (1887.50)	-180.98 (1762.31)

4. Secondary Outcome

Title	Change in Truncal Fat Mass (Week 87)
Description	Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	52	109	48	47
Mean (Standard Deviation) [grams]	-311.85 (1771.78)	-196.18 (2249.21)	-685.56 (2258.93)	364.08 (2548.85)

5. Secondary Outcome

Title	Change in Truncal Lean Body Mass (Week 34)
Description	Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	111	116
Mean (Standard Deviation) [grams]	402.69 (1247.67)	832.77 (1409.74)	800.27 (1377.75)

6. Secondary Outcome

Title	Change in Truncal Lean Body Mass (Week 87)
Description	Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	52	109	48	47
Mean (Standard Deviation) [grams]	1197.30 (1500.56)	1152.79 (1480.06)	975.79 (1258.62)	1015.12 (1554.88)

7. Secondary Outcome

Title	Change in Total Fat Mass (Week 34)
Description	Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	111	116
Mean (Standard Deviation) [grams]	305.47 (2689.06)	-855.71 (3167.06)	-85.47 (3022.71)

8. Secondary Outcome

Title	Change in Total Fat Mass (Week 87)
Description	Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	52	109	48	47
Mean (Standard Deviation) [grams]	-540.04 (3250.16)	-118.07 (3795.36)	-923.01 (4099.45)	874.56 (4789.34)

9. Secondary Outcome

Title	Change in Visceral Adipose Tissue (Week 34)
Description	Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	53	104	105
Mean (Standard Deviation) [centimeter square]	4.41 (13.81)	-9.68 (21.37)	-11.61 (23.93)

10. Secondary Outcome

Title	Change in Visceral Adipose Tissue (Week 87)
Description	Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	48	97	40	43
Mean (Standard Deviation) [centimeter square]	-9.34 (25.67)	-6.71 (33.07)	-5.17 (20.11)	-5.97 (28.86)

11. Secondary Outcome

Title	Change in Android Fat Mass (Week 34)
Description	Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	55	110	114
Mean (Standard Deviation) [gram]	56.32 (293.93)	-158.98 (325.35)	-81.52 (361.62)

12. Secondary Outcome

Title	Change in Android Fat Mass (Week 87)
Description	Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	51	107	47	47
Mean (Standard Deviation) [gram]	-107.16 (367.14)	-39.76 (481.66)	-100.76 (386.24)	11.52 (489.85)

13. Secondary Outcome

Title	Change in Gynoid Fat Mass (Week 34)
Description	Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	55	110	114
Mean (Standard Deviation) [gram]	8.35 (567.04)	-128.59 (471.00)	22.66 (510.45)

14. Secondary Outcome

Title	Change in Gynoid Fat Mass (Week 87)
Description	Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	51	107	47	47
Mean (Standard Deviation) [gram]	-92.00 (759.37)	10.23 (557.20)	-100.97 (620.16)	140.02 (790.74)

15. Secondary Outcome

Title	Change in Appendicular Skeletal Muscle Mass (Week 34)
Description	Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	111	116
Mean (Standard Deviation) [gram]	-76.22 (1006.58)	482.76 (1246.89)	565.21 (1011.18)

16. Secondary Outcome

Title	Change in Appendicular Skeletal Muscle Mass (Week 87)
Description	Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	52	109	48	47
Mean (Standard Deviation) [gram]	447.96 (1688.08)	538.45 (1224.13)	464.75 (1513.96)	632.18 (1928.68)

17. Secondary Outcome

Title	Change in Lean Body Mass (Week 34)
Description	Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	111	116
Mean (Standard Deviation) [gram]	334.43 (2048.01)	1359.33 (2359.11)	1395.88 (2139.32)

18. Secondary Outcome

Title	Change in Lean Body Mass (Week 87)
Description	Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	52	109	48	47
Mean (Standard Deviation) [gram]	1717.15 (2965.23)	1719.87 (2515.90)	1464.51 (2439.75)	1681.82 (3413.61)

19. Secondary Outcome

Title	Change in Bone Mineral Content (Week 87)
Description	Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	110	48	47
Mean (Standard Deviation) [gram]	-25.61 (93.35)	5.02 (113.81)	-10.18 (99.18)	32.33 (87.86)

20. Secondary Outcome

Title	Change in Bone Mineral Density (Week 87)
Description	Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	110	48	47
Mean (Standard Deviation) [grams per square centimeter]	-0.01 (0.04)	-0.00 (0.04)	-0.00 (0.04)	0.01 (0.04)

21. Secondary Outcome

Title	Change in IGF-I SDS (Week 34)
Description	Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	113	116
Mean (Standard Deviation) [Standard deviation score]	0.05 (0.59)	2.28 (1.32)	2.37 (1.33)

22. Secondary Outcome

Title	Change in IGF-I SDS (Week 87)
Description	Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	110	47	47
Mean (Standard Deviation) [Standard deviation score]	2.36 (1.55)	2.29 (1.39)	2.07 (1.12)	2.35 (1.54)

23. Secondary Outcome

Title	Change in IGFBP 3 SDS (Week 34)
Description	Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	113	116
Mean (Standard Deviation) [Standard deviation score]	0.12 (0.61)	1.44 (1.17)	1.56 (1.24)

24. Secondary Outcome

Title	Change in IGFBP 3 SDS (Week 87)
Description	Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	110	47	47
Mean (Standard Deviation) [Standard deviation score]	1.33 (1.20)	1.41 (1.20)	1.30 (1.08)	1.47 (1.51)

25. Secondary Outcome

Title	Change in TRIM-AGHD (Total and Domain Scores) (Week 34)
Description	Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
Time Frame	Week 0, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	61	119	120
Energy	-3.96 (25.40)	-13.42 (23.73)	-7.81 (24.07)
Psychological	-3.38 (12.15)	-8.93 (14.21)	-4.63 (12.01)
Cognitive	-2.25 (18.17)	-7.06 (18.47)	-3.92 (17.29)
Physical	-5.88 (14.72)	-11.33 (19.23)	-7.39 (19.25)
Total	-3.65 (12.05)	-9.99 (13.64)	-5.71 (12.69)

26. Secondary Outcome

Title	Change in TRIM-AGHD (Total and Domain Scores) (Week 87)
Description	Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
Time Frame	week 0, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	61	120	52	51
Energy	-11.73 (30.87)	-8.11 (25.46)	-23.30 (28.03)	-9.13 (26.98)
Psychological	-6.97 (16.05)	-6.64 (14.56)	-15.64 (15.36)	-7.35 (10.50)
Cognitive	-4.88 (21.19)	-5.55 (18.59)	-14.18 (20.29)	-7.71 (14.14)
Physical	-11.19 (20.13)	-9.57 (21.94)	-17.22 (27.02)	-13.54 (18.02)
Total	-8.28 (15.88)	-7.25 (14.42)	-17.38 (16.77)	-8.67 (11.73)

27. Secondary Outcome

Title	Change in SF-36v2 (Summary and Domain Scores) (Week 34)
Description	SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Time Frame	Week 0, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	61	119	120
Physical functioning	2.19 (6.44)	2.46 (7.08)	3.18 (7.67)
Role limitations due to physical health	2.49 (7.68)	3.95 (8.48)	3.14 (9.06)
Role limitations due to emotional health	2.29 (9.52)	3.50 (10.87)	3.06 (11.60)
Vitality	3.21 (7.67)	5.26 (9.89)	2.38 (8.56)
Role limitations due to mental health	0.85 (9.59)	3.72 (10.17)	2.78 (9.56)
Social functioning	0.10 (10.43)	3.19 (9.80)	2.87 (9.69)
Bodily pain	0.63 (8.79)	2.19 (9.50)	1.79 (9.52)
General health	1.50 (7.25)	4.47 (7.64)	1.85 (7.58)
Overall physical	2.01 (6.22)	2.87 (6.33)	2.40 (6.53)
Overall mental	1.28 (8.72)	4.09 (10.19)	2.70 (9.29)

28. Secondary Outcome

Title	Change in SF-36v2 (Summary and Domain Scores) (Week 87)
Description	SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Time Frame	week 0, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	61	120	52	51
Physical functioning	2.87 (8.13)	3.83 (7.66)	3.43 (6.96)	1.84 (8.07)
Role limitations due to physical health	3.31 (9.81)	4.16 (10.10)	4.65 (10.06)	2.45 (10.50)
Role limitations due to emotional health	3.46 (11.59)	3.46 (12.25)	7.30 (13.46)	1.13 (11.20)
Vitality	6.71 (11.01)	4.18 (9.30)	8.16 (12.77)	4.16 (8.88)
Role limitations due to mental health	2.80 (10.55)	3.66 (8.12)	6.12 (13.02)	1.70 (10.31)
Social functioning	3.84 (10.36)	3.44 (10.29)	4.56 (10.34)	0.57 (11.26)
Bodily pain	1.41 (8.57)	1.47 (10.29)	3.51 (9.57)	0.30 (11.25)
General health	3.46 (7.33)	3.32 (7.70)	5.66 (9.67)	2.20 (8.66)
Overall physical score	2.66 (6.91)	2.98 (7.24)	3.06 (7.07)	1.81 (7.72)
Overall mental score	4.51 (10.39)	3.56 (9.06)	7.50 (13.59)	1.66 (10.18)

29. Secondary Outcome

Title	TSQM-9 Scores (Domain Scores) (Week 34)
Description	Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
Time Frame	Week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	61	119	120
Effectiveness	49.6 (22.2)	67.1 (21.8)	56.1 (22.5)
Convenience	74.3 (16.9)	73.9 (18.7)	77.7 (15.3)
Global satisfaction	54.0 (24.8)	69.0 (24.0)	63.1 (24.2)

30. Secondary Outcome

Title	TSQM-9 Scores (Domain Scores) (Week 87)
Description	Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
Time Frame	Week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	61	120	52	51
Effectiveness	59.7 (23.1)	65.7 (22.4)	69.6 (24.0)	70.9 (20.9)
Convenience	75.1 (19.1)	80.0 (16.5)	72.6 (20.0)	79.4 (17.1)
Global satisfaction	63.2 (26.2)	68.1 (24.6)	71.7 (25.3)	75.1 (23.6)

31. Secondary Outcome

Title	Change in Total Cholesterol (Week 34)
Description	Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	119
Mean (Standard Deviation) [mmol/L]	0.03 (0.96)	-0.10 (0.91)	-0.09 (0.78)

32. Secondary Outcome

Title	Change in Total Cholesterol (Week 87)
Description	Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [mmol/L]	-0.21 (0.89)	0.03 (0.96)	-0.05 (0.94)	-0.33 (1.08)

33. Secondary Outcome

Title	Change in HDL-cholesterol (Week 34)
Description	Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	119
Mean (Standard Deviation) [mmol/L]	-0.00 (0.37)	0.02 (0.28)	0.05 (0.30)

34. Secondary Outcome

Title	Change in HDL-cholesterol (Week 87)
Description	Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [mmol/L]	0.06 (0.30)	0.05 (0.32)	0.09 (0.27)	0.06 (0.34)

35. Secondary Outcome

Title	Change in LDL-cholesterol (Week 34)
Description	Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	119
Mean (Standard Deviation) [mmol/L]	0.02 (0.75)	-0.18 (0.72)	-0.13 (0.64)

36. Secondary Outcome

Title	Change in LDL-cholesterol (Week 87)
Description	Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [mmol/L]	-0.30 (0.72)	-0.06 (0.81)	-0.15 (0.85)	-0.36 (0.90)

37. Secondary Outcome

Title	Change in Triglycerides (Week 34)
Description	Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	119
Mean (Standard Deviation) [mmol/L]	0.01 (0.65)	0.13 (0.62)	-0.02 (0.73)

38. Secondary Outcome

Title	Change in Triglycerides (Week 87)
Description	Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [mmol/L]	0.07 (0.48)	0.03 (0.76)	0.03 (0.56)	-0.08 (0.73)

39. Secondary Outcome

Title	Change in Hs-CRP (Week 34)
Description	Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	116
Mean (Standard Deviation) [mg/L]	0.405 (13.144)	-1.604 (13.254)	-0.569 (5.616)

40. Secondary Outcome

Title	Change in Hs-CRP (Week 87)
Description	Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	111	49	49
Mean (Standard Deviation) [mg/L]	-0.325 (16.247)	-1.445 (3.791)	-0.857 (17.491)	-1.257 (12.497)

41. Secondary Outcome

Title	Change in IL-6 (Week 34)
Description	Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	113	118
Mean (Standard Deviation) [pg/mL]	3.48 (24.84)	0.07 (4.01)	0.18 (5.78)

42. Secondary Outcome

Title	Change in IL-6 (Week 87)
Description	Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	111	48	47
Mean (Standard Deviation) [pg/mL]	0.11 (3.30)	0.52 (6.19)	0.49 (5.12)	1.19 (2.92)

43. Secondary Outcome

Title	Change in Body Weight (Week 34)
Description	Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	119
Mean (Standard Deviation) [Kg]	0.6 (2.9)	0.2 (4.0)	1.3 (4.2)

44. Secondary Outcome

Title	Change in Body Weight (Week 87)
Description	Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [Kg]	1.2 (4.4)	1.4 (4.8)	0.4 (5.2)	2.1 (7.0)

45. Secondary Outcome

Title	Change in Waist Circumference (Week 34)
Description	Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	55	113	117
Mean (Standard Deviation) [cm]	0.82 (4.50)	-0.66 (4.83)	-0.00 (4.52)

46. Secondary Outcome

Title	Change in Waist Circumference (Week 87)
Description	Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analysed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	111	49	49
Mean (Standard Deviation) [cm]	1.35 (5.62)	0.53 (5.17)	-2.26 (7.93)	0.74 (7.17)

47. Secondary Outcome

Title	Number of Adverse Events (Weeks 0-35)
Description	Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.
Time Frame	Weeks 0-35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	61	119	120
Number [Events]	184	426	385

48. Secondary Outcome

Title	Number of Adverse Events (Weeks 0-88)
Description	Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.
Time Frame	Weeks 0-88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan	Norditropin/-
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Measure Participants	61	120	52	51	16
Number [Events]	395	699	384	385	49

49. Secondary Outcome

Title	Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)
Description	Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
Time Frame	Weeks 0 to 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	61	109	120
Count of Participants [Participants]	0 0%	1 0.8%	0 0%

50. Secondary Outcome

Title	Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)
Description	Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
Time Frame	Weeks 0 to 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan	Norditropin/-
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Measure Participants	61	120	52	51	16
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	1 NaN

51. Secondary Outcome

Title	Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)
Description	Incidence of technical complaints were recorded from baseline (week 0) until week 35.
Time Frame	Weeks 0 to 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	61	119	120
Number [Technical complaints]	1	14	0

52. Secondary Outcome

Title	Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)
Description	Incidence of technical complaints were recorded from baseline (week 0) until week 88.
Time Frame	Weeks 0 to 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	61	120	52	51
Number [Technical complaints]	1	6	18	7

53. Secondary Outcome

Title	Change in Physical Examination During Exposure to Trial Product (Week 35)
Description	Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation
Time Frame	Week 0 and week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	61	119	120
Normal	55 90.2%	111 93.3%	108 90%
Abnormal, not clinically significant (NCS)	6 9.8%	6 5%	7 5.8%
Abnormal, clinically significant (CS)	0 0%	2 1.7%	5 4.2%
Missing	0 0%	0 0%	0 0%
Normal	51 83.6%	98 82.4%	107 89.2%
Abnormal, not clinically significant (NCS)	5 8.2%	4 3.4%	9 7.5%
Abnormal, clinically significant (CS)	0 0%	3 2.5%	2 1.7%
Missing	0 0%	0 0%	0 0%
Normal	61 100%	118 99.2%	119 99.2%
Abnormal, not clinically significant (NCS)	0 0%	1 0.8%	1 0.8%
Abnormal, clinically significant (CS)	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	56 91.8%	103 86.6%	117 97.5%
Abnormal, not clinically significant (NCS)	0 0%	2 1.7%	1 0.8%
Abnormal, clinically significant (CS)	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	56 91.8%	112 94.1%	116 96.7%
Abnormal, not clinically significant (NCS)	4 6.6%	7 5.9%	4 3.3%
Abnormal, clinically significant (CS)	1 1.6%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	54 88.5%	99 83.2%	112 93.3%
Abnormal, not clinically significant (NCS)	1 1.6%	6 5%	6 5%
Abnormal, clinically significant (CS)	1 1.6%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	59 96.7%	113 95%	119 99.2%
Abnormal, not clinically significant (NCS)	2 3.3%	6 5%	1 0.8%
Abnormal, clinically significant (CS)	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	53 86.9%	98 82.4%	116 96.7%
Abnormal, not clinically significant (NCS)	3 4.9%	7 5.9%	2 1.7%
Abnormal, clinically significant (CS)	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	59 96.7%	111 93.3%	113 94.2%
Abnormal, not clinically significant (NCS)	2 3.3%	6 5%	5 4.2%
Abnormal, clinically significant (CS)	0 0%	2 1.7%	2 1.7%
Missing	0 0%	0 0%	0 0%
Normal	54 88.5%	96 80.7%	111 92.5%
Abnormal, not clinically significant (NCS)	2 3.3%	7 5.9%	5 4.2%
Abnormal, clinically significant (CS)	0 0%	2 1.7%	2 1.7%
Missing	0 0%	0 0%	0 0%
Normal	59 96.7%	113 95%	117 97.5%
Abnormal, not clinically significant (NCS)	2 3.3%	5 4.2%	3 2.5%
Abnormal, clinically significant (CS)	0 0%	1 0.8%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	55 90.2%	101 84.9%	114 95%
Abnormal, not clinically significant (NCS)	1 1.6%	4 3.4%	4 3.3%
Abnormal, clinically significant (CS)	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	51 83.6%	100 84%	109 90.8%
Abnormal, not clinically significant (NCS)	9 14.8%	17 14.3%	11 9.2%
Abnormal, clinically significant (CS)	1 1.6%	2 1.7%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	51 83.6%	88 73.9%	102 85%
Abnormal, not clinically significant (NCS)	5 8.2%	15 12.6%	13 10.8%
Abnormal, clinically significant (CS)	0 0%	2 1.7%	3 2.5%
Missing	0 0%	0 0%	0 0%
Normal	61 100%	119 100%	120 100%
Abnormal, not clinically significant (NCS)	0 0%	0 0%	0 0%
Abnormal, clinically significant (CS)	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%
Normal	56 91.8%	105 88.2%	118 98.3%
Abnormal, not clinically significant (NCS)	0 0%	0 0%	0 0%
Abnormal, clinically significant (CS)	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%

54. Secondary Outcome

Title	Change in Physical Examination During Exposure to Trial Product (Week 88)
Description	Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation
Time Frame	Week 0 and week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan	Norditropin/-
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Measure Participants	61	120	52	51	16
Normal	55 90.2%	108 90.8%	49 40.8%	47 15.7%	15 NaN
Abnormal, NCS	6 9.8%	7 5.9%	2 1.7%	3 1%	1 NaN
Abnormal, CS	0 0%	5 4.2%	1 0.8%	1 0.3%	0 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	48 78.7%	101 84.9%	46 38.3%	44 14.7%	0 NaN
Abnormal, NCS	6 9.8%	7 5.9%	2 1.7%	1 0.3%	0 NaN
Abnormal, CS	0 0%	1 0.8%	1 0.8%	3 1%	0 NaN
Missing	0 0%	1 0.8%	0 0%	0 0%	0 NaN
Normal	61 100%	119 100%	52 43.3%	50 16.7%	16 NaN
Abnormal, NCS	0 0%	1 0.8%	0 0%	1 0.3%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	54 88.5%	109 91.6%	49 40.8%	47 15.7%	0 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	1 0.3%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	1 0.8%	0 0%	0 0%	0 NaN
Normal	56 91.8%	116 97.5%	49 40.8%	47 15.7%	16 NaN
Abnormal, NCS	4 6.6%	4 3.4%	3 2.5%	4 1.3%	0 NaN
Abnormal, CS	1 1.6%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	52 85.2%	107 89.9%	45 37.5%	47 15.7%	0 NaN
Abnormal, NCS	1 1.6%	2 1.7%	4 3.3%	1 0.3%	0 NaN
Abnormal, CS	1 1.6%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	1 0.8%	0 0%	0 0%	0 NaN
Normal	59 96.7%	119 100%	49 40.8%	49 16.3%	15 NaN
Abnormal, NCS	2 3.3%	1 0.8%	3 2.5%	2 0.7%	1 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	52 85.2%	109 91.6%	47 39.2%	48 16%	0 NaN
Abnormal, NCS	2 3.3%	0 0%	2 1.7%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	1 0.8%	0 0%	0 0%	0 NaN
Normal	59 96.7%	113 95%	48 40%	49 16.3%	14 NaN
Abnormal, NCS	2 3.3%	5 4.2%	2 1.7%	2 0.7%	2 NaN
Abnormal, CS	0 0%	2 1.7%	2 1.7%	0 0%	0 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	49 80.3%	101 84.9%	45 37.5%	46 15.3%	0 NaN
Abnormal, NCS	4 6.6%	7 5.9%	3 2.5%	2 0.7%	0 NaN
Abnormal, CS	1 1.6%	1 0.8%	1 0.8%	0 0%	0 NaN
Missing	0 0%	1 0.8%	0 0%	0 0%	0 NaN
Normal	59 96.7%	117 98.3%	51 42.5%	48 16%	14 NaN
Abnormal, NCS	2 3.3%	3 2.5%	1 0.8%	3 1%	1 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	1 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	53 86.9%	106 89.1%	49 40.8%	45 15%	0 NaN
Abnormal, NCS	1 1.6%	3 2.5%	0 0%	3 1%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	1 0.8%	0 0%	0 0%	0 NaN
Normal	51 83.6%	109 91.6%	48 40%	41 13.7%	11 NaN
Abnormal, NCS	9 14.8%	11 9.2%	3 2.5%	10 3.3%	4 NaN
Abnormal, CS	1 1.6%	0 0%	1 0.8%	0 0%	1 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	49 80.3%	96 80.7%	42 35%	42 14%	0 NaN
Abnormal, NCS	3 4.9%	8 6.7%	6 5%	5 1.7%	0 NaN
Abnormal, CS	2 3.3%	5 4.2%	1 0.8%	1 0.3%	0 NaN
Missing	0 0%	1 0.8%	0 0%	0 0%	0 NaN
Normal	61 100%	120 100.8%	52 43.3%	51 17%	16 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	53 86.9%	108 90.8%	49 40.8%	48 16%	0 NaN
Abnormal, NCS	0 0%	1 0.8%	0 0%	0 0%	0 NaN
Abnormal, CS	1 1.6%	0 0%	0 0%	0 0%	0 NaN
Missing	0 0%	1 0.8%	0 0%	0 0%	0 NaN

55. Secondary Outcome

Title	Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)
Description	Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.
Time Frame	Week -3 and week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	61	119	120
Normal	30 49.2%	67 56.3%	77 64.2%
Abnormal, NCS	29 47.5%	52 43.7%	40 33.3%
Abnormal, CS	2 3.3%	0 0%	3 2.5%
Missing	0 0%	0 0%	0 0%
Normal	29 47.5%	65 54.6%	77 64.2%
Abnormal, NCS	26 42.6%	42 35.3%	34 28.3%
Abnormal, CS	1 1.6%	0 0%	2 1.7%
Missing	1 1.6%	4 3.4%	6 5%

56. Secondary Outcome

Title	Change in ECG Evaluation During Exposure to Trial Product (Week 88)
Description	Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.
Time Frame	Week -3 and week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan	Norditropin/-
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Measure Participants	61	120	52	51	16
Normal	30 49.2%	77 64.7%	26 21.7%	34 11.3%	7 NaN
Abnormal, NCS	29 47.5%	40 33.6%	26 21.7%	17 5.7%	9 NaN
Abnormal, CS	2 3.3%	3 2.5%	0 0%	0 0%	0 NaN
Missing	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	34 55.7%	74 62.2%	29 24.2%	35 11.7%	0 NaN
Abnormal, NCS	18 29.5%	34 28.6%	18 15%	12 4%	0 NaN
Abnormal, CS	1 1.6%	1 0.8%	2 1.7%	1 0.3%	0 NaN
Missing	1 1.6%	0 0%	0 0%	1 0.3%	1 NaN

57. Secondary Outcome

Title	Change in Diastolic Blood Pressure (Week 35)
Description	Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time Frame	Week -3, week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	107	118
Mean (Standard Deviation) [mm Hg]	-0.41 (7.75)	-2.07 (8.73)	-1.42 (8.98)

58. Secondary Outcome

Title	Change in Diastolic Blood Pressure (Week 88)
Description	Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.
Time Frame	Week -3, week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	110	49	48
Mean (Standard Deviation) [mm Hg]	-2.48 (7.77)	-0.85 (9.21)	-0.61 (8.71)	-2.10 (9.50)

59. Secondary Outcome

Title	Change in Systolic Blood Pressure (Week 35)
Description	Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time Frame	Week -3, week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	107	118
Mean (Standard Deviation) [mm Hg]	1.13 (11.35)	-2.81 (13.33)	-1.39 (12.89)

60. Secondary Outcome

Title	Change in Systolic Blood Pressure (Week 88)
Description	Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Time Frame	Week -3, week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	110	49	48
Mean (Standard Deviation) [mm Hg]	-1.30 (12.18)	0.45 (13.01)	-1.35 (13.07)	-1.83 (11.63)

61. Secondary Outcome

Title	Change in Pulse (Week 35)
Description	Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time Frame	Week -3, week 35

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	119
Mean (Standard Deviation) [beats/min]	0.54 (9.43)	2.61 (9.74)	1.02 (10.20)

62. Secondary Outcome

Title	Change in Pulse (Week 88)
Description	Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Time Frame	Week -3, week 88

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	110	49	48
Mean (Standard Deviation) [beats/min]	0.78 (11.70)	-0.55 (10.51)	-0.55 (10.32)	0.08 (8.75)

63. Secondary Outcome

Title	Change in Haemoglobin (Week 34)
Description	Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	112	119
Mean (Standard Deviation) [g/L]	1.87 (10.25)	-0.51 (8.80)	0.64 (8.78)

64. Secondary Outcome

Title	Change in Haemoglobin (Week 87)
Description	Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	109	48	48
Mean (Standard Deviation) [g/L]	2.93 (11.36)	2.76 (9.54)	-0.40 (9.22)	0.86 (15.96)

65. Secondary Outcome

Title	Change in Haematocrit (Week 34)
Description	Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	112	119
Mean (Standard Deviation) [% of red blood cells]	0.5 (3.3)	-0.3 (2.9)	0.1 (3.1)

66. Secondary Outcome

Title	Change in Haematocrit (Week 87)
Description	Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	109	48	48
Mean (Standard Deviation) [% of red blood cells]	0.17 (3.44)	0.21 (3.29)	-0.59 (2.78)	-0.48 (5.10)

67. Secondary Outcome

Title	Change in Erythrocytes (Week 34)
Description	Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	112	119
Mean (Standard Deviation) [cells/pL]	0.09 (0.33)	0.06 (0.29)	0.08 (0.32)

68. Secondary Outcome

Title	Change in Erythrocytes (Week 87)
Description	Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	109	48	48
Mean (Standard Deviation) [cells/pL]	0.09 (0.34)	0.12 (0.35)	0.01 (0.31)	0.05 (0.54)

69. Secondary Outcome

Title	Change in Mean Corpuscular Volume (MCV) (Week 34)
Description	Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	112	119
Mean (Standard Deviation) [fL]	-0.6 (3.3)	-1.8 (3.6)	-1.5 (3.0)

70. Secondary Outcome

Title	Change in Mean Corpuscular Volume (MCV) (Week 87)
Description	Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	109	48	48
Mean (Standard Deviation) [fL]	-1.39 (4.27)	-1.80 (3.31)	-1.31 (3.63)	-1.77 (3.66)

71. Secondary Outcome

Title	Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)
Description	Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	112	119
Mean (Standard Deviation) [mmol/L]	0.1 (0.5)	0.1 (0.6)	0.1 (0.6)

72. Secondary Outcome

Title	Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)
Description	Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	109	48	48
Mean (Standard Deviation) [mmol/L]	0.36 (0.47)	0.29 (0.61)	0.23 (0.70)	0.35 (0.52)

73. Secondary Outcome

Title	Change in Thrombocytes (Week 34)
Description	Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	111	115
Mean (Standard Deviation) [10^9 cells/L]	1.6 (37.4)	10.8 (37.1)	15.3 (35.0)

74. Secondary Outcome

Title	Change in Thrombocytes (Week 87)
Description	Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	108	47	48
Mean (Standard Deviation) [10^9 cells/L]	-1.2 (44.7)	11.0 (36.7)	-0.9 (31.3)	6.6 (53.4)

75. Secondary Outcome

Title	Change in Leucocytes (Week 34)
Description	Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	112	119
Mean (Standard Deviation) [10^9 cells/L]	0.22 (1.57)	-0.05 (1.50)	-0.32 (1.75)

76. Secondary Outcome

Title	Change in Leucocytes (Week 87)
Description	Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	109	48	48
Mean (Standard Deviation) [10^9 cells/L]	0.29 (1.93)	-0.12 (1.94)	-0.14 (1.44)	-0.14 (2.55)

77. Secondary Outcome

Title	Change in Alanine Aminotransferase (ALT) (Week 34)
Description	Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [U/L]	4.5 (24.7)	-1.4 (11.9)	-4.4 (17.9)

78. Secondary Outcome

Title	Change in Alanine Aminotransferase (ALT) (Week 87)
Description	Change in ALT was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [U/L]	-1.1 (13.1)	-4.3 (16.9)	0.6 (12.5)	-3.0 (14.6)

79. Secondary Outcome

Title	Change in Albumin (Week 34)
Description	Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [g/L]	6.09 (3.56)	-0.72 (2.81)	-0.42 (3.06)

80. Secondary Outcome

Title	Change in Albumin (Week 87)
Description	Change in Albumin was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [g/L]	-1.19 (3.15)	-0.86 (3.12)	-1.12 (3.52)	-1.69 (3.01)

81. Secondary Outcome

Title	Change in Alkaline Phosphatase (ALP) (Week 34)
Description	Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	112	118
Mean (Standard Deviation) [U/L]	1.8 (16.5)	7.9 (24.3)	5.8 (14.9)

82. Secondary Outcome

Title	Change in Alkaline Phosphatase (AP) (Week 87)
Description	Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	48	49
Mean (Standard Deviation) [U/L]	8.1 (20.2)	5.4 (16.0)	3.3 (22.2)	4.2 (18.0)

83. Secondary Outcome

Title	Change in Aspartate Aminotransferase (AST) (Week 34)
Description	Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [U/L]	1.96 (15.11)	-0.80 (9.38)	-2.00 (13.97)

84. Secondary Outcome

Title	Change in Aspartate Aminotransferase (AST) (Week 87)
Description	Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	Week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [U/L]	1.76 (24.346)	-2.17 (13.98)	-0.43 (5.94)	-1.69 (12.75)

85. Secondary Outcome

Title	Change in Bilirubin (Week 34)
Description	Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [umol/L]	-0.08 (4.76)	-0.38 (4.10)	-0.41 (4.09)

86. Secondary Outcome

Title	Change in Bilirubin (Week 87)
Description	Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	111	47	48
Mean (Standard Deviation) [umol/L]	0.04 (3.77)	0.14 (4.45)	0.45 (3.24)	-0.33 (4.52)

87. Secondary Outcome

Title	Change in Calcium (Week 34)
Description	Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	112	118
Mean (Standard Deviation) [mmol/L]	0.00 (0.13)	0.04 (0.14)	0.03 (0.11)

88. Secondary Outcome

Title	Change in Calcium (Week 87)
Description	Change in Calcium was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [mmol/L]	0.01 (0.12)	0.03 (0.12)	0.03 (0.11)	0.01 (0.12)

89. Secondary Outcome

Title	Change in Chloride (Week 34)
Description	Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [mmol/L]	-1.1 (2.7)	-0.6 (2.9)	-0.3 (2.9)

90. Secondary Outcome

Title	Change in Chloride (Week 87)
Description	Change in Chloride was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [mmol/L]	-1.8 (3.5)	-1.0 (3.0)	-1.1 (3.2)	-0.6 (3.1)

91. Secondary Outcome

Title	Change in Creatinine (Week 34)
Description	Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [umol/L]	0.9 (9.4)	-2.8 (10.9)	-2.9 (10.6)

92. Secondary Outcome

Title	Change in Creatinine (Week 87)
Description	Change in Creatinine was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [umol/L]	-5.6 (11.9)	-2.5 (11.7)	-2.0 (9.8)	1.8 (41.2)

93. Secondary Outcome

Title	Change in Creatine Kinase (Week 34)
Description	Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [U/L]	5.0 (136.6)	10.9 (101.0)	-23.5 (355.0)

94. Secondary Outcome

Title	Change in Creatine Kinase (Week 87)
Description	Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [U/L]	228.7 (1603.3)	-9.4 (411.3)	1.3 (89.3)	30.5 (125.7)

95. Secondary Outcome

Title	Change in Gamma-glutamyl Transferase (GGT) (Week 34)
Description	Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [U/L]	9.3 (66.2)	-5.8 (17.0)	-4.2 (27.5)

96. Secondary Outcome

Title	Change in Gamma-glutamyl Transferase (GGT) (Week 87)
Description	Change in GGT was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [U/L]	19.4 (16.4)	29.3 (39.3)	25.9 (23.8)	20.7 (13.9)

97. Secondary Outcome

Title	Change in Phosphate (Inorganic) (Week 34)
Description	Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [mmol/L]	-0.038 (0.183)	0.155 (0.182)	0.181 (0.202)

98. Secondary Outcome

Title	Change in Phosphate (Inorganic)(Week 87)
Description	Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [mmol/L]	0.100 (0.190)	0.125 (0.193)	0.076 (0.190)	0.115 (0.219)

99. Secondary Outcome

Title	Change in Potassium (Week 34)
Description	Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	52	113	118
Mean (Standard Deviation) [mmol/L]	0.02 (0.44)	-0.06 (0.39)	0.04 (9.42)

100. Secondary Outcome

Title	Change in Potassium (Week 87)
Description	Change in Potassium was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	112	49	49
Mean (Standard Deviation) [mmol/L]	-0.06 (0.45)	0.00 (0.44)	-0.00 (0.40)	-0.03 (0.43)

101. Secondary Outcome

Title	Change in Sodium (Week 34)
Description	Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	55	108	115
Mean (Standard Deviation) [mmol/L]	0.1 (2.4)	0.1 (2.9)	0.5 (2.7)

102. Secondary Outcome

Title	Change in Sodium (Week 87)
Description	Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	48	49
Mean (Standard Deviation) [mmol/L]	-0.7 (3.35)	0.0 (2.92)	-0.3 (2.74)	0.5 (2.76)

103. Secondary Outcome

Title	Change in Total Protein (Week 34)
Description	Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [g/L]	-0.26 (5.48)	-0.97 (4.36)	-0.83 (4.93)

104. Secondary Outcome

Title	Change in Total Protein (Week 87)
Description	Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [g/L]	-1.20 (5.17)	-0.74 (4.88)	-1.31 (4.91)	-1.59 (4.37)

105. Secondary Outcome

Title	Change in Urea (Week 34)
Description	Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [mmol/L]	0.17 (1.27)	-0.40 (1.16)	-0.19 (1.24)

106. Secondary Outcome

Title	Change in Urea (Week 87)
Description	Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [mmol/L]	0.11 (1.40)	-0.21 (1.28)	-0.26 (1.35)	-0.03 (2.46)

107. Secondary Outcome

Title	Change in Uric Acid (Week 34)
Description	Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [umol/L]	-8.228 (52.557)	-12.61 (50.534)	-21.11 (57.594)

108. Secondary Outcome

Title	Change in Uric Acid (Week 87)
Description	Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	112	49	49
Mean (Standard Deviation) [umol/L]	-25.22 (59.042)	-21.95 (58.903)	-18.02 (59.716)	-31.31 (86.787)

109. Secondary Outcome

Title	Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)
Description	Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	113	118
Mean (Standard Deviation) [mL/min/1.73m^2]	-1.34 (10.68)	2.77 (10.07)	2.57 (11.24)

110. Secondary Outcome

Title	Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)
Description	Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	111	49	49
Mean (Standard Deviation) [mL/min/1.73m^2]	5.36 (12.67)	2.38 (12.28)	1.44 (10.52)	1.67 (15.77)

111. Secondary Outcome

Title	Change in Fasting Plasma Glucose (Week 34)
Description	Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	55	112	117
Mean (Standard Deviation) [mmol/L]	0.01 (0.42)	0.12 (0.65)	0.00 (0.56)

112. Secondary Outcome

Title	Change in Fasting Plasma Glucose (Week 87)
Description	Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	108	49	48
Mean (Standard Deviation) [mmol/L]	0.06 (0.46)	0.13 (0.77)	0.05 (0.68)	0.04 (0.60)

113. Secondary Outcome

Title	Change in Fasting Insulin (Week 34)
Description	Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	56	112	117
Mean (Standard Deviation) [pmol/L]	14.563 (45.217)	27.580 (76.230)	12.778 (53.703)

114. Secondary Outcome

Title	Change in Fasting Insulin (Week 87)
Description	Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	110	48	48
Mean (Standard Deviation) [pmol/L]	12.2 (57.31)	-3.7 (62.39)	-6.5 (53.67)	13.4 (54.40)

115. Secondary Outcome

Title	Change in Steady State Beta Cell Function (%B) (Week 34)
Description	Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	53	108	113
Mean (Standard Deviation) [Percentage of beta cell function]	27.10 (105.45)	36.26 (290.00)	54.90 (173.14)

116. Secondary Outcome

Title	Change in Steady State Beta Cell Function (%B) (Week 87)
Description	Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	105	46	46
Mean (Standard Deviation) [Percentage of beta cell function]	21.72 (154.22)	-16.54 (148.72)	-7.34 (97.62)	34.54 (161.01)

117. Secondary Outcome

Title	Change in Insulin Resistance (IR %) (Week 34)
Description	Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	53	109	114
Mean (Standard Deviation) [Percentage of insulin resistance]	0.53 (1.76)	1.26 (3.42)	0.47 (2.32)

118. Secondary Outcome

Title	Change in Insulin Resistance (IR %) (Week 87)
Description	Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	53	106	46	47
Mean (Standard Deviation) [Percentage of insulin resistance]	0.50 (2.17)	-0.06 (3.14)	-0.02 (1.99)	0.52 (2.26)

119. Secondary Outcome

Title	Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)
Description	Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time Frame	Week -3, week 34

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo	Norditropin	Somapacitan
Arm/Group Description	Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Measure Participants	57	111	119
Mean (Standard Deviation) [Percentage of HbA1c]	0.04 (0.37)	0.09 (0.26)	0.09 (0.31)

120. Secondary Outcome

Title	Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)
Description	Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time Frame	week -3, week 87

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed = number of participants with available data.

Arm/Group Title	Placebo/Somapacitan	Somapacitan/Somapacitan	Norditropin/Norditropin	Norditropin/Somapacitan
Arm/Group Description	Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Measure Participants	54	110	49	48
Mean (Standard Deviation) [Percentage of HbA1c]	0.09 (0.26)	0.11 (0.37)	0.10 (0.28)	0.07 (0.27)

Adverse Events

Time Frame	Weeks 0-88
Adverse Event Reporting Description	All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Arm/Group Title	Placebo - Main Phase		Somapacitan - Main Phase		Norditropin - Main Phase		Somapacitan - Extension Phase		Norditropin- Extension Phase
Arm/Group Description	Participants received placebo for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.		Participants received somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.		Participants received Norditropin® for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.		The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the following listed participants: 1) participants who received placebo in the main phase, and switched to receive somapacitan in the extension phase. 2) Participants who received somapacitan in the main phase were continued to receive somapacitan in the extension phase. 3) Participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive somapacitan in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).		The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive Norditropin® in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).
All Cause Mortality
	Placebo - Main Phase		Somapacitan - Main Phase		Norditropin - Main Phase		Somapacitan - Extension Phase		Norditropin- Extension Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/61 (1.6%)		0/120 (0%)		1/119 (0.8%)		2/220 (0.9%)		1/52 (1.9%)
Serious Adverse Events
	Placebo - Main Phase		Somapacitan - Main Phase		Norditropin - Main Phase		Somapacitan - Extension Phase		Norditropin- Extension Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/61 (8.2%)		7/120 (5.8%)		12/119 (10.1%)		15/220 (6.8%)		3/52 (5.8%)
Blood and lymphatic system disorders
Haemoconcentration	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Cardiac disorders
Cardiogenic shock	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Ventricular extrasystoles	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Ventricular fibrillation	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Endocrine disorders
Adrenocortical insufficiency acute	1/61 (1.6%)	1	1/120 (0.8%)	1	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Diabetes insipidus	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Hypopituitarism	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Secondary adrenocortical insufficiency	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Dental cyst	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Diarrhoea	1/61 (1.6%)	1	0/120 (0%)	0	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Inguinal hernia	0/61 (0%)	0	1/120 (0.8%)	1	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Pancreatitis acute	1/61 (1.6%)	1	0/120 (0%)	0	0/119 (0%)	0	0/220 (0%)	0	1/52 (1.9%)	1
Stomatitis	0/61 (0%)	0	1/120 (0.8%)	1	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Vomiting	1/61 (1.6%)	1	1/120 (0.8%)	1	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
General disorders
Death	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Fatigue	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	2/220 (0.9%)	2	0/52 (0%)	0
Non-cardiac chest pain	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Pyrexia	0/61 (0%)	0	1/120 (0.8%)	1	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Infections and infestations
Appendicitis	0/61 (0%)	0	1/120 (0.8%)	1	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Clostridium difficile infection	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Gastroenteritis	0/61 (0%)	0	2/120 (1.7%)	2	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Gastroenteritis viral	1/61 (1.6%)	1	1/120 (0.8%)	1	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Herpes simplex	0/61 (0%)	0	1/120 (0.8%)	1	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Influenza	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Pneumonia	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	0/220 (0%)	0	1/52 (1.9%)	1
Pneumonia viral	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Sepsis	0/61 (0%)	0	1/120 (0.8%)	1	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Urinary tract infection	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	1/52 (1.9%)	1
Urosepsis	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	0/220 (0%)	0	1/52 (1.9%)	2
Viral infection	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Viral upper respiratory tract infection	0/61 (0%)	0	1/120 (0.8%)	1	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Injury, poisoning and procedural complications
Drug dispensing error	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Fall	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Spinal compression fracture	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Tibia fracture	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Tooth fracture	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Toxicity to various agents	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Investigations
Blood testosterone increased	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Cholangiogram	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Electrocardiogram T wave abnormal	1/61 (1.6%)	1	0/120 (0%)	0	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Metabolism and nutrition disorders
Hyponatraemia	1/61 (1.6%)	1	0/120 (0%)	0	0/119 (0%)	0	0/220 (0%)	0	0/52 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Plasma cell myeloma	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Nervous system disorders
Depressed level of consciousness	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Headache	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Psychiatric disorders
Delirium	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Renal and urinary disorders
Chronic kidney disease	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Nephrolithiasis	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Pneumonia aspiration	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Sleep apnoea syndrome	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis atopic	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	0/52 (0%)	0
Surgical and medical procedures
Arterial stent insertion	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Cholecystectomy	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Umbilical hernia repair	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Vascular disorders
Hypertension	0/61 (0%)	0	0/120 (0%)	0	0/119 (0%)	0	1/220 (0.5%)	1	0/52 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo - Main Phase		Somapacitan - Main Phase		Norditropin - Main Phase		Somapacitan - Extension Phase		Norditropin- Extension Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/61 (47.5%)		53/120 (44.2%)		55/119 (46.2%)		85/220 (38.6%)		27/52 (51.9%)
Eye disorders
Visual impairment	0/61 (0%)	0	0/120 (0%)	0	1/119 (0.8%)	1	0/220 (0%)	0	3/52 (5.8%)	3
Gastrointestinal disorders
Diarrhoea	5/61 (8.2%)	7	4/120 (3.3%)	5	5/119 (4.2%)	5	14/220 (6.4%)	21	3/52 (5.8%)	3
Nausea	1/61 (1.6%)	1	2/120 (1.7%)	2	6/119 (5%)	8	5/220 (2.3%)	14	0/52 (0%)	0
General disorders
Fatigue	2/61 (3.3%)	2	3/120 (2.5%)	3	7/119 (5.9%)	7	9/220 (4.1%)	11	0/52 (0%)	0
Injection site bruising	2/61 (3.3%)	3	1/120 (0.8%)	1	6/119 (5%)	6	0/220 (0%)	0	0/52 (0%)	0
Oedema peripheral	0/61 (0%)	0	5/120 (4.2%)	7	6/119 (5%)	8	7/220 (3.2%)	17	1/52 (1.9%)	1
Infections and infestations
Nasopharyngitis	9/61 (14.8%)	12	23/120 (19.2%)	29	20/119 (16.8%)	25	33/220 (15%)	41	6/52 (11.5%)	8
Tooth abscess	0/61 (0%)	0	1/120 (0.8%)	1	0/119 (0%)	0	2/220 (0.9%)	2	3/52 (5.8%)	3
Upper respiratory tract infection	7/61 (11.5%)	7	6/120 (5%)	7	9/119 (7.6%)	10	17/220 (7.7%)	18	3/52 (5.8%)	6
Musculoskeletal and connective tissue disorders
Arthralgia	1/61 (1.6%)	1	8/120 (6.7%)	8	11/119 (9.2%)	11	7/220 (3.2%)	8	3/52 (5.8%)	4
Back pain	2/61 (3.3%)	2	11/120 (9.2%)	11	4/119 (3.4%)	4	5/220 (2.3%)	7	0/52 (0%)	0
Myalgia	3/61 (4.9%)	3	1/120 (0.8%)	1	3/119 (2.5%)	3	5/220 (2.3%)	7	3/52 (5.8%)	3
Nervous system disorders
Headache	10/61 (16.4%)	15	10/120 (8.3%)	45	11/119 (9.2%)	50	25/220 (11.4%)	48	6/52 (11.5%)	23
Skin and subcutaneous tissue disorders
Rash	2/61 (3.3%)	2	3/120 (2.5%)	3	3/119 (2.5%)	4	2/220 (0.9%)	2	3/52 (5.8%)	4
Vascular disorders
Hypertension	1/61 (1.6%)	1	4/120 (3.3%)	4	4/119 (3.4%)	4	3/220 (1.4%)	3	3/52 (5.8%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property