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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02229851




Registration number
NCT02229851
Ethics application status
Date submitted
26/08/2014
Date registered
3/09/2014
Date last updated
7/07/2020

Titles & IDs
Public title
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
Scientific 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
Secondary ID [1] 0 0
2013-002892-16
Secondary ID [2] 0 0
NN8640-4054
Universal Trial Number (UTN)
Trial acronym
REAL 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth Hormone Disorder 0 0
Adult Growth Hormone Deficiency 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - somapacitan
Treatment: Drugs - somatropin
Treatment: Drugs - placebo

Experimental: NNC0195-0092 (somapacitan) -

Active Comparator: Daily hGH -

Placebo Comparator: Placebo - Switch to NNC0195-0092 (somapacitan) treatment in the extension period.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: placebo
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Truncal Fat Percentage (Week 34) - Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [1] 0 0
Week -3, week 34
Secondary outcome [1] 0 0
Change in Truncal Fat Percentage (Week 87) - Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [1] 0 0
week -3, week 87
Secondary outcome [2] 0 0
Change in Truncal Fat Mass (Week 34) - Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [2] 0 0
Week -3, week 34
Secondary outcome [3] 0 0
Change in Truncal Fat Mass (Week 87) - Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [3] 0 0
week -3, week 87
Secondary outcome [4] 0 0
Change in Truncal Lean Body Mass (Week 34) - Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [4] 0 0
Week -3, week 34
Secondary outcome [5] 0 0
Change in Truncal Lean Body Mass (Week 87) - Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [5] 0 0
week -3, week 87
Secondary outcome [6] 0 0
Change in Total Fat Mass (Week 34) - Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [6] 0 0
Week -3, week 34
Secondary outcome [7] 0 0
Change in Total Fat Mass (Week 87) - Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [7] 0 0
Week -3, week 87
Secondary outcome [8] 0 0
Change in Visceral Adipose Tissue (Week 34) - Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [8] 0 0
Week -3, week 34
Secondary outcome [9] 0 0
Change in Visceral Adipose Tissue (Week 87) - Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [9] 0 0
Week -3, week 87
Secondary outcome [10] 0 0
Change in Android Fat Mass (Week 34) - Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [10] 0 0
Week -3, week 34
Secondary outcome [11] 0 0
Change in Android Fat Mass (Week 87) - Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [11] 0 0
week -3, week 87
Secondary outcome [12] 0 0
Change in Gynoid Fat Mass (Week 34) - Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [12] 0 0
Week -3, week 34
Secondary outcome [13] 0 0
Change in Gynoid Fat Mass (Week 87) - Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [13] 0 0
week -3, week 87
Secondary outcome [14] 0 0
Change in Appendicular Skeletal Muscle Mass (Week 34) - Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [14] 0 0
Week -3, week 34
Secondary outcome [15] 0 0
Change in Appendicular Skeletal Muscle Mass (Week 87) - Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [15] 0 0
week -3, week 87
Secondary outcome [16] 0 0
Change in Lean Body Mass (Week 34) - Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [16] 0 0
Week -3, week 34
Secondary outcome [17] 0 0
Change in Lean Body Mass (Week 87) - Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [17] 0 0
week -3, week 87
Secondary outcome [18] 0 0
Change in Bone Mineral Content (Week 87) - Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [18] 0 0
week -3, week 87
Secondary outcome [19] 0 0
Change in Bone Mineral Density (Week 87) - Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [19] 0 0
week -3, week 87
Secondary outcome [20] 0 0
Change in IGF-I SDS (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.
Timepoint [20] 0 0
Week -3, week 34
Secondary outcome [21] 0 0
Change in IGF-I SDS (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.
Timepoint [21] 0 0
Week -3, week 87
Secondary outcome [22] 0 0
Change in IGFBP 3 SDS (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).
Timepoint [22] 0 0
Week -3, week 34
Secondary outcome [23] 0 0
Change in IGFBP 3 SDS (Week 87) - Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [23] 0 0
Week -3, week 87
Secondary outcome [24] 0 0
Change in TRIM-AGHD (Total and Domain Scores) (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.
Timepoint [24] 0 0
Week 0, week 34
Secondary outcome [25] 0 0
Change in TRIM-AGHD (Total and Domain Scores) (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.
Timepoint [25] 0 0
week 0, week 87
Secondary outcome [26] 0 0
Change in SF-36v2 (Summary and Domain Scores) (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.
Timepoint [26] 0 0
Week 0, week 34
Secondary outcome [27] 0 0
Change in SF-36v2 (Summary and Domain Scores) (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.
Timepoint [27] 0 0
week 0, week 87
Secondary outcome [28] 0 0
TSQM-9 Scores (Domain Scores) (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.
Timepoint [28] 0 0
Week 34
Secondary outcome [29] 0 0
TSQM-9 Scores (Domain Scores) (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.
Timepoint [29] 0 0
Week 87
Secondary outcome [30] 0 0
Change in Total Cholesterol (Week 34) - Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [30] 0 0
Week -3, week 34
Secondary outcome [31] 0 0
Change in Total Cholesterol (Week 87) - Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [31] 0 0
week -3, week 87
Secondary outcome [32] 0 0
Change in HDL-cholesterol (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).
Timepoint [32] 0 0
Week -3, week 34
Secondary outcome [33] 0 0
Change in HDL-cholesterol (Week 87) - Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [33] 0 0
week -3, week 87
Secondary outcome [34] 0 0
Change in LDL-cholesterol (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).
Timepoint [34] 0 0
Week -3, week 34
Secondary outcome [35] 0 0
Change in LDL-cholesterol (Week 87) - Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [35] 0 0
week -3, week 87
Secondary outcome [36] 0 0
Change in Triglycerides (Week 34) - Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [36] 0 0
Week -3, week 34
Secondary outcome [37] 0 0
Change in Triglycerides (Week 87) - Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [37] 0 0
week -3, week 87
Secondary outcome [38] 0 0
Change in Hs-CRP (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).
Timepoint [38] 0 0
Week -3, week 34
Secondary outcome [39] 0 0
Change in Hs-CRP (Week 87) - Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [39] 0 0
week -3, week 87
Secondary outcome [40] 0 0
Change in IL-6 (Week 34) - Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [40] 0 0
Week -3, week 34
Secondary outcome [41] 0 0
Change in IL-6 (Week 87) - Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [41] 0 0
week -3, week 87
Secondary outcome [42] 0 0
Change in Body Weight (Week 34) - Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [42] 0 0
Week -3, week 34
Secondary outcome [43] 0 0
Change in Body Weight (Week 87) - Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [43] 0 0
week -3, week 87
Secondary outcome [44] 0 0
Change in Waist Circumference (Week 34) - Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [44] 0 0
Week -3, week 34
Secondary outcome [45] 0 0
Change in Waist Circumference (Week 87) - Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [45] 0 0
week -3, week 87
Secondary outcome [46] 0 0
Number of Adverse Events (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.
Timepoint [46] 0 0
Weeks 0-35
Secondary outcome [47] 0 0
Number of Adverse Events (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.
Timepoint [47] 0 0
Weeks 0-88
Secondary outcome [48] 0 0
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) - 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.
Timepoint [48] 0 0
Weeks 0 to 35
Secondary outcome [49] 0 0
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) - 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.
Timepoint [49] 0 0
Weeks 0 to 88
Secondary outcome [50] 0 0
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) - Incidence of technical complaints were recorded from baseline (week 0) until week 35.
Timepoint [50] 0 0
Weeks 0 to 35
Secondary outcome [51] 0 0
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) - Incidence of technical complaints were recorded from baseline (week 0) until week 88.
Timepoint [51] 0 0
Weeks 0 to 88
Secondary outcome [52] 0 0
Change in Physical Examination During Exposure to Trial Product (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
Timepoint [52] 0 0
Week 0 and week 35
Secondary outcome [53] 0 0
Change in Physical Examination During Exposure to Trial Product (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
Timepoint [53] 0 0
Week 0 and week 88
Secondary outcome [54] 0 0
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) - Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.
Timepoint [54] 0 0
Week -3 and week 35
Secondary outcome [55] 0 0
Change in ECG Evaluation During Exposure to Trial Product (Week 88) - Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.
Timepoint [55] 0 0
Week -3 and week 88
Secondary outcome [56] 0 0
Change in Diastolic Blood Pressure (Week 35) - Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Timepoint [56] 0 0
Week -3, week 35
Secondary outcome [57] 0 0
Change in Diastolic Blood Pressure (Week 88) - Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.
Timepoint [57] 0 0
Week -3, week 88
Secondary outcome [58] 0 0
Change in Systolic Blood Pressure (Week 35) - Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Timepoint [58] 0 0
Week -3, week 35
Secondary outcome [59] 0 0
Change in Systolic Blood Pressure (Week 88) - Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Timepoint [59] 0 0
Week -3, week 88
Secondary outcome [60] 0 0
Change in Pulse (Week 35) - Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).
Timepoint [60] 0 0
Week -3, week 35
Secondary outcome [61] 0 0
Change in Pulse (Week 88) - Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Timepoint [61] 0 0
Week -3, week 88
Secondary outcome [62] 0 0
Change in Haemoglobin (Week 34) - Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [62] 0 0
Week -3, week 34
Secondary outcome [63] 0 0
Change in Haemoglobin (Week 87) - Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.
Timepoint [63] 0 0
week -3, week 87
Secondary outcome [64] 0 0
Change in Haematocrit (Week 34) - Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [64] 0 0
Week -3, week 34
Secondary outcome [65] 0 0
Change in Haematocrit (Week 87) - Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.
Timepoint [65] 0 0
week -3, week 87
Secondary outcome [66] 0 0
Change in Erythrocytes (Week 34) - Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [66] 0 0
Week -3, week 34
Secondary outcome [67] 0 0
Change in Erythrocytes (Week 87) - Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.
Timepoint [67] 0 0
week -3, week 87
Secondary outcome [68] 0 0
Change in Mean Corpuscular Volume (MCV) (Week 34) - Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [68] 0 0
Week -3, week 34
Secondary outcome [69] 0 0
Change in Mean Corpuscular Volume (MCV) (Week 87) - Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.
Timepoint [69] 0 0
week -3, week 87
Secondary outcome [70] 0 0
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (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).
Timepoint [70] 0 0
Week -3, week 34
Secondary outcome [71] 0 0
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) - Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.
Timepoint [71] 0 0
week -3, week 87
Secondary outcome [72] 0 0
Change in Thrombocytes (Week 34) - Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [72] 0 0
Week -3, week 34
Secondary outcome [73] 0 0
Change in Thrombocytes (Week 87) - Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.
Timepoint [73] 0 0
week -3, week 87
Secondary outcome [74] 0 0
Change in Leucocytes (Week 34) - Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [74] 0 0
Week -3, week 34
Secondary outcome [75] 0 0
Change in Leucocytes (Week 87) - Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.
Timepoint [75] 0 0
week -3, week 87
Secondary outcome [76] 0 0
Change in Alanine Aminotransferase (ALT) (Week 34) - Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [76] 0 0
Week -3, week 34
Secondary outcome [77] 0 0
Change in Alanine Aminotransferase (ALT) (Week 87) - Change in ALT was measured from baseline (week -3) until the end of the week 87.
Timepoint [77] 0 0
week -3, week 87
Secondary outcome [78] 0 0
Change in Albumin (Week 34) - Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [78] 0 0
Week -3, week 34
Secondary outcome [79] 0 0
Change in Albumin (Week 87) - Change in Albumin was measured from baseline (week -3) until the end of the week 87.
Timepoint [79] 0 0
week -3, week 87
Secondary outcome [80] 0 0
Change in Alkaline Phosphatase (ALP) (Week 34) - Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [80] 0 0
Week -3, week 34
Secondary outcome [81] 0 0
Change in Alkaline Phosphatase (AP) (Week 87) - Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.
Timepoint [81] 0 0
Week -3, week 87
Secondary outcome [82] 0 0
Change in Aspartate Aminotransferase (AST) (Week 34) - Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [82] 0 0
Week -3, week 34
Secondary outcome [83] 0 0
Change in Aspartate Aminotransferase (AST) (Week 87) - Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [83] 0 0
Week -3, week 87
Secondary outcome [84] 0 0
Change in Bilirubin (Week 34) - Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [84] 0 0
Week -3, week 34
Secondary outcome [85] 0 0
Change in Bilirubin (Week 87) - Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [85] 0 0
week -3, week 87
Secondary outcome [86] 0 0
Change in Calcium (Week 34) - Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [86] 0 0
Week -3, week 34
Secondary outcome [87] 0 0
Change in Calcium (Week 87) - Change in Calcium was measured from baseline (week -3) until the end of the week 87.
Timepoint [87] 0 0
week -3, week 87
Secondary outcome [88] 0 0
Change in Chloride (Week 34) - Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [88] 0 0
Week -3, week 34
Secondary outcome [89] 0 0
Change in Chloride (Week 87) - Change in Chloride was measured from baseline (week -3) until the end of the week 87.
Timepoint [89] 0 0
week -3, week 87
Secondary outcome [90] 0 0
Change in Creatinine (Week 34) - Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [90] 0 0
Week -3, week 34
Secondary outcome [91] 0 0
Change in Creatinine (Week 87) - Change in Creatinine was measured from baseline (week -3) until the end of the week 87.
Timepoint [91] 0 0
week -3, week 87
Secondary outcome [92] 0 0
Change in Creatine Kinase (Week 34) - Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [92] 0 0
Week -3, week 34
Secondary outcome [93] 0 0
Change in Creatine Kinase (Week 87) - Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.
Timepoint [93] 0 0
week -3, week 87
Secondary outcome [94] 0 0
Change in Gamma-glutamyl Transferase (GGT) (Week 34) - Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [94] 0 0
Week -3, week 34
Secondary outcome [95] 0 0
Change in Gamma-glutamyl Transferase (GGT) (Week 87) - Change in GGT was measured from baseline (week -3) until the end of the week 87.
Timepoint [95] 0 0
week -3, week 87
Secondary outcome [96] 0 0
Change in Phosphate (Inorganic) (Week 34) - Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [96] 0 0
Week -3, week 34
Secondary outcome [97] 0 0
Change in Phosphate (Inorganic)(Week 87) - Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.
Timepoint [97] 0 0
week -3, week 87
Secondary outcome [98] 0 0
Change in Potassium (Week 34) - Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [98] 0 0
Week -3, week 34
Secondary outcome [99] 0 0
Change in Potassium (Week 87) - Change in Potassium was measured from baseline (week -3) until the end of the week 87.
Timepoint [99] 0 0
week -3, week 87
Secondary outcome [100] 0 0
Change in Sodium (Week 34) - Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [100] 0 0
Week -3, week 34
Secondary outcome [101] 0 0
Change in Sodium (Week 87) - Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [101] 0 0
week -3, week 87
Secondary outcome [102] 0 0
Change in Total Protein (Week 34) - Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [102] 0 0
Week -3, week 34
Secondary outcome [103] 0 0
Change in Total Protein (Week 87) - Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).
Timepoint [103] 0 0
week -3, week 87
Secondary outcome [104] 0 0
Change in Urea (Week 34) - Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [104] 0 0
Week -3, week 34
Secondary outcome [105] 0 0
Change in Urea (Week 87) - Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [105] 0 0
week -3, week 87
Secondary outcome [106] 0 0
Change in Uric Acid (Week 34) - Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [106] 0 0
Week -3, week 34
Secondary outcome [107] 0 0
Change in Uric Acid (Week 87) - Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [107] 0 0
week -3, week 87
Secondary outcome [108] 0 0
Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (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).
Timepoint [108] 0 0
Week -3, week 34
Secondary outcome [109] 0 0
Change in Estimated GFR Creatinine (CKD-EPI) (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).
Timepoint [109] 0 0
week -3, week 87
Secondary outcome [110] 0 0
Change in Fasting Plasma Glucose (Week 34) - Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [110] 0 0
Week -3, week 34
Secondary outcome [111] 0 0
Change in Fasting Plasma Glucose (Week 87) - Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [111] 0 0
week -3, week 87
Secondary outcome [112] 0 0
Change in Fasting Insulin (Week 34) - Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [112] 0 0
Week -3, week 34
Secondary outcome [113] 0 0
Change in Fasting Insulin (Week 87) - Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [113] 0 0
week -3, week 87
Secondary outcome [114] 0 0
Change in Steady State Beta Cell Function (%B) (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).
Timepoint [114] 0 0
Week -3, week 34
Secondary outcome [115] 0 0
Change in Steady State Beta Cell Function (%B) (Week 87) - Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.
Timepoint [115] 0 0
week -3, week 87
Secondary outcome [116] 0 0
Change in Insulin Resistance (IR %) (Week 34) - Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [116] 0 0
Week -3, week 34
Secondary outcome [117] 0 0
Change in Insulin Resistance (IR %) (Week 87) - Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [117] 0 0
week -3, week 87
Secondary outcome [118] 0 0
Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) - Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Timepoint [118] 0 0
Week -3, week 34
Secondary outcome [119] 0 0
Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) - Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Timepoint [119] 0 0
week -3, week 87

Eligibility
Key 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):

a. 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)
Minimum age
23 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Coffs Harbour
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Darlinghurst
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Woolloongabba
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Germany
State/province [20] 0 0
Aachen
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Frankfurt
Country [23] 0 0
Germany
State/province [23] 0 0
Oldenburg
Country [24] 0 0
India
State/province [24] 0 0
Andhra Pradesh
Country [25] 0 0
India
State/province [25] 0 0
Karnataka
Country [26] 0 0
India
State/province [26] 0 0
Kerala
Country [27] 0 0
India
State/province [27] 0 0
Maharashtra
Country [28] 0 0
India
State/province [28] 0 0
New Delhi
Country [29] 0 0
India
State/province [29] 0 0
Punjab
Country [30] 0 0
India
State/province [30] 0 0
Telengana
Country [31] 0 0
India
State/province [31] 0 0
West Bengal
Country [32] 0 0
Israel
State/province [32] 0 0
Petah-Tikva
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Hashomer
Country [34] 0 0
Israel
State/province [34] 0 0
Tel-Aviv
Country [35] 0 0
Japan
State/province [35] 0 0
Bunkyo-ku, Tokyo
Country [36] 0 0
Japan
State/province [36] 0 0
Chiba-shi, Chiba
Country [37] 0 0
Japan
State/province [37] 0 0
Fukuoka-shi, Fukuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Hamamatsu-shi, Shizuoka
Country [39] 0 0
Japan
State/province [39] 0 0
Itabashi-ku, Tokyo
Country [40] 0 0
Japan
State/province [40] 0 0
Kagoshima
Country [41] 0 0
Japan
State/province [41] 0 0
Kyoto-shi Kyoto
Country [42] 0 0
Japan
State/province [42] 0 0
Minato-ku, Tokyo
Country [43] 0 0
Japan
State/province [43] 0 0
Okayama, Okayama
Country [44] 0 0
Japan
State/province [44] 0 0
Sagamihara-shi, Kanagawa
Country [45] 0 0
Japan
State/province [45] 0 0
Sapporo, Hokkaido
Country [46] 0 0
Japan
State/province [46] 0 0
Sappro-shi, Hokkaido
Country [47] 0 0
Japan
State/province [47] 0 0
Tokyo
Country [48] 0 0
Japan
State/province [48] 0 0
Yamagata-shi, Yamagata
Country [49] 0 0
Japan
State/province [49] 0 0
Yokohama, Kanagawa
Country [50] 0 0
Latvia
State/province [50] 0 0
Riga
Country [51] 0 0
Lithuania
State/province [51] 0 0
Kaunas
Country [52] 0 0
Lithuania
State/province [52] 0 0
Vilnius
Country [53] 0 0
Malaysia
State/province [53] 0 0
Kuching
Country [54] 0 0
Malaysia
State/province [54] 0 0
Pulau Pinang
Country [55] 0 0
Malaysia
State/province [55] 0 0
Putrajaya
Country [56] 0 0
Norway
State/province [56] 0 0
Oslo
Country [57] 0 0
Poland
State/province [57] 0 0
Bialystok
Country [58] 0 0
Poland
State/province [58] 0 0
Gdansk
Country [59] 0 0
Poland
State/province [59] 0 0
Krakow
Country [60] 0 0
Poland
State/province [60] 0 0
Warszawa
Country [61] 0 0
Poland
State/province [61] 0 0
Wroclaw
Country [62] 0 0
Romania
State/province [62] 0 0
Cluj
Country [63] 0 0
Romania
State/province [63] 0 0
Mures
Country [64] 0 0
Romania
State/province [64] 0 0
Bucuresti
Country [65] 0 0
Romania
State/province [65] 0 0
Iasi
Country [66] 0 0
Romania
State/province [66] 0 0
Sibiu
Country [67] 0 0
Romania
State/province [67] 0 0
Timisoara
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Kazan
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Krasnoyarsk
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Novosibirsk
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Tomsk
Country [73] 0 0
South Africa
State/province [73] 0 0
Gauteng
Country [74] 0 0
South Africa
State/province [74] 0 0
Western Cape
Country [75] 0 0
Sweden
State/province [75] 0 0
Göteborg
Country [76] 0 0
Sweden
State/province [76] 0 0
Stockholm
Country [77] 0 0
Sweden
State/province [77] 0 0
Uppsala
Country [78] 0 0
Turkey
State/province [78] 0 0
Adana
Country [79] 0 0
Turkey
State/province [79] 0 0
Istanbul
Country [80] 0 0
Turkey
State/province [80] 0 0
Izmir
Country [81] 0 0
Turkey
State/province [81] 0 0
Kocaeli
Country [82] 0 0
Ukraine
State/province [82] 0 0
Kiev
Country [83] 0 0
Ukraine
State/province [83] 0 0
Kyiv
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Birmingham
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Coventry
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Exeter
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Hull
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Leeds
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02229851
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Reporting Anchor and Disclosure' (1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications