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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02229851
Ethics application status
Date submitted
26/08/2014
Date registered
3/09/2014
Date last updated
23/11/2020

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)
Timepoint [1] 0 0
Week -3, week 34
Secondary outcome [1] 0 0
Change in Truncal Fat Percentage (Week 87)
Timepoint [1] 0 0
week -3, week 87
Secondary outcome [2] 0 0
Change in Truncal Fat Mass (Week 34)
Timepoint [2] 0 0
Week -3, week 34
Secondary outcome [3] 0 0
Change in Truncal Fat Mass (Week 87)
Timepoint [3] 0 0
week -3, week 87
Secondary outcome [4] 0 0
Change in Truncal Lean Body Mass (Week 34)
Timepoint [4] 0 0
Week -3, week 34
Secondary outcome [5] 0 0
Change in Truncal Lean Body Mass (Week 87)
Timepoint [5] 0 0
week -3, week 87
Secondary outcome [6] 0 0
Change in Total Fat Mass (Week 34)
Timepoint [6] 0 0
Week -3, week 34
Secondary outcome [7] 0 0
Change in Total Fat Mass (Week 87)
Timepoint [7] 0 0
Week -3, week 87
Secondary outcome [8] 0 0
Change in Visceral Adipose Tissue (Week 34)
Timepoint [8] 0 0
Week -3, week 34
Secondary outcome [9] 0 0
Change in Visceral Adipose Tissue (Week 87)
Timepoint [9] 0 0
Week -3, week 87
Secondary outcome [10] 0 0
Change in Android Fat Mass (Week 34)
Timepoint [10] 0 0
Week -3, week 34
Secondary outcome [11] 0 0
Change in Android Fat Mass (Week 87)
Timepoint [11] 0 0
week -3, week 87
Secondary outcome [12] 0 0
Change in Gynoid Fat Mass (Week 34)
Timepoint [12] 0 0
Week -3, week 34
Secondary outcome [13] 0 0
Change in Gynoid Fat Mass (Week 87)
Timepoint [13] 0 0
week -3, week 87
Secondary outcome [14] 0 0
Change in Appendicular Skeletal Muscle Mass (Week 34)
Timepoint [14] 0 0
Week -3, week 34
Secondary outcome [15] 0 0
Change in Appendicular Skeletal Muscle Mass (Week 87)
Timepoint [15] 0 0
week -3, week 87
Secondary outcome [16] 0 0
Change in Lean Body Mass (Week 34)
Timepoint [16] 0 0
Week -3, week 34
Secondary outcome [17] 0 0
Change in Lean Body Mass (Week 87)
Timepoint [17] 0 0
week -3, week 87
Secondary outcome [18] 0 0
Change in Bone Mineral Content (Week 87)
Timepoint [18] 0 0
week -3, week 87
Secondary outcome [19] 0 0
Change in Bone Mineral Density (Week 87)
Timepoint [19] 0 0
week -3, week 87
Secondary outcome [20] 0 0
Change in IGF-I SDS (Week 34)
Timepoint [20] 0 0
Week -3, week 34
Secondary outcome [21] 0 0
Change in IGF-I SDS (Week 87)
Timepoint [21] 0 0
Week -3, week 87
Secondary outcome [22] 0 0
Change in IGFBP 3 SDS (Week 34)
Timepoint [22] 0 0
Week -3, week 34
Secondary outcome [23] 0 0
Change in IGFBP 3 SDS (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)
Timepoint [24] 0 0
Week 0, week 34
Secondary outcome [25] 0 0
Change in TRIM-AGHD (Total and Domain Scores) (Week 87)
Timepoint [25] 0 0
week 0, week 87
Secondary outcome [26] 0 0
Change in SF-36v2 (Summary and Domain Scores) (Week 34)
Timepoint [26] 0 0
Week 0, week 34
Secondary outcome [27] 0 0
Change in SF-36v2 (Summary and Domain Scores) (Week 87)
Timepoint [27] 0 0
week 0, week 87
Secondary outcome [28] 0 0
TSQM-9 Scores (Domain Scores) (Week 34)
Timepoint [28] 0 0
Week 34
Secondary outcome [29] 0 0
TSQM-9 Scores (Domain Scores) (Week 87)
Timepoint [29] 0 0
Week 87
Secondary outcome [30] 0 0
Change in Total Cholesterol (Week 34)
Timepoint [30] 0 0
Week -3, week 34
Secondary outcome [31] 0 0
Change in Total Cholesterol (Week 87)
Timepoint [31] 0 0
week -3, week 87
Secondary outcome [32] 0 0
Change in HDL-cholesterol (Week 34)
Timepoint [32] 0 0
Week -3, week 34
Secondary outcome [33] 0 0
Change in HDL-cholesterol (Week 87)
Timepoint [33] 0 0
week -3, week 87
Secondary outcome [34] 0 0
Change in LDL-cholesterol (Week 34)
Timepoint [34] 0 0
Week -3, week 34
Secondary outcome [35] 0 0
Change in LDL-cholesterol (Week 87)
Timepoint [35] 0 0
week -3, week 87
Secondary outcome [36] 0 0
Change in Triglycerides (Week 34)
Timepoint [36] 0 0
Week -3, week 34
Secondary outcome [37] 0 0
Change in Triglycerides (Week 87)
Timepoint [37] 0 0
week -3, week 87
Secondary outcome [38] 0 0
Change in Hs-CRP (Week 34)
Timepoint [38] 0 0
Week -3, week 34
Secondary outcome [39] 0 0
Change in Hs-CRP (Week 87)
Timepoint [39] 0 0
week -3, week 87
Secondary outcome [40] 0 0
Change in IL-6 (Week 34)
Timepoint [40] 0 0
Week -3, week 34
Secondary outcome [41] 0 0
Change in IL-6 (Week 87)
Timepoint [41] 0 0
week -3, week 87
Secondary outcome [42] 0 0
Change in Body Weight (Week 34)
Timepoint [42] 0 0
Week -3, week 34
Secondary outcome [43] 0 0
Change in Body Weight (Week 87)
Timepoint [43] 0 0
week -3, week 87
Secondary outcome [44] 0 0
Change in Waist Circumference (Week 34)
Timepoint [44] 0 0
Week -3, week 34
Secondary outcome [45] 0 0
Change in Waist Circumference (Week 87)
Timepoint [45] 0 0
week -3, week 87
Secondary outcome [46] 0 0
Number of Adverse Events (Weeks 0-35)
Timepoint [46] 0 0
Weeks 0-35
Secondary outcome [47] 0 0
Number of Adverse Events (Weeks 0-88)
Timepoint [47] 0 0
Weeks 0-88
Secondary outcome [48] 0 0
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)
Timepoint [48] 0 0
Weeks 0 to 35
Secondary outcome [49] 0 0
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)
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)
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)
Timepoint [51] 0 0
Weeks 0 to 88
Secondary outcome [52] 0 0
Change in Physical Examination During Exposure to Trial Product (Week 35)
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)
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)
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)
Timepoint [55] 0 0
Week -3 and week 88
Secondary outcome [56] 0 0
Change in Diastolic Blood Pressure (Week 35)
Timepoint [56] 0 0
Week -3, week 35
Secondary outcome [57] 0 0
Change in Diastolic Blood Pressure (Week 88)
Timepoint [57] 0 0
Week -3, week 88
Secondary outcome [58] 0 0
Change in Systolic Blood Pressure (Week 35)
Timepoint [58] 0 0
Week -3, week 35
Secondary outcome [59] 0 0
Change in Systolic Blood Pressure (Week 88)
Timepoint [59] 0 0
Week -3, week 88
Secondary outcome [60] 0 0
Change in Pulse (Week 35)
Timepoint [60] 0 0
Week -3, week 35
Secondary outcome [61] 0 0
Change in Pulse (Week 88)
Timepoint [61] 0 0
Week -3, week 88
Secondary outcome [62] 0 0
Change in Haemoglobin (Week 34)
Timepoint [62] 0 0
Week -3, week 34
Secondary outcome [63] 0 0
Change in Haemoglobin (Week 87)
Timepoint [63] 0 0
week -3, week 87
Secondary outcome [64] 0 0
Change in Haematocrit (Week 34)
Timepoint [64] 0 0
Week -3, week 34
Secondary outcome [65] 0 0
Change in Haematocrit (Week 87)
Timepoint [65] 0 0
week -3, week 87
Secondary outcome [66] 0 0
Change in Erythrocytes (Week 34)
Timepoint [66] 0 0
Week -3, week 34
Secondary outcome [67] 0 0
Change in Erythrocytes (Week 87)
Timepoint [67] 0 0
week -3, week 87
Secondary outcome [68] 0 0
Change in Mean Corpuscular Volume (MCV) (Week 34)
Timepoint [68] 0 0
Week -3, week 34
Secondary outcome [69] 0 0
Change in Mean Corpuscular Volume (MCV) (Week 87)
Timepoint [69] 0 0
week -3, week 87
Secondary outcome [70] 0 0
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)
Timepoint [70] 0 0
Week -3, week 34
Secondary outcome [71] 0 0
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)
Timepoint [71] 0 0
week -3, week 87
Secondary outcome [72] 0 0
Change in Thrombocytes (Week 34)
Timepoint [72] 0 0
Week -3, week 34
Secondary outcome [73] 0 0
Change in Thrombocytes (Week 87)
Timepoint [73] 0 0
week -3, week 87
Secondary outcome [74] 0 0
Change in Leucocytes (Week 34)
Timepoint [74] 0 0
Week -3, week 34
Secondary outcome [75] 0 0
Change in Leucocytes (Week 87)
Timepoint [75] 0 0
week -3, week 87
Secondary outcome [76] 0 0
Change in Alanine Aminotransferase (ALT) (Week 34)
Timepoint [76] 0 0
Week -3, week 34
Secondary outcome [77] 0 0
Change in Alanine Aminotransferase (ALT) (Week 87)
Timepoint [77] 0 0
week -3, week 87
Secondary outcome [78] 0 0
Change in Albumin (Week 34)
Timepoint [78] 0 0
Week -3, week 34
Secondary outcome [79] 0 0
Change in Albumin (Week 87)
Timepoint [79] 0 0
week -3, week 87
Secondary outcome [80] 0 0
Change in Alkaline Phosphatase (ALP) (Week 34)
Timepoint [80] 0 0
Week -3, week 34
Secondary outcome [81] 0 0
Change in Alkaline Phosphatase (AP) (Week 87)
Timepoint [81] 0 0
Week -3, week 87
Secondary outcome [82] 0 0
Change in Aspartate Aminotransferase (AST) (Week 34)
Timepoint [82] 0 0
Week -3, week 34
Secondary outcome [83] 0 0
Change in Aspartate Aminotransferase (AST) (Week 87)
Timepoint [83] 0 0
Week -3, week 87
Secondary outcome [84] 0 0
Change in Bilirubin (Week 34)
Timepoint [84] 0 0
Week -3, week 34
Secondary outcome [85] 0 0
Change in Bilirubin (Week 87)
Timepoint [85] 0 0
week -3, week 87
Secondary outcome [86] 0 0
Change in Calcium (Week 34)
Timepoint [86] 0 0
Week -3, week 34
Secondary outcome [87] 0 0
Change in Calcium (Week 87)
Timepoint [87] 0 0
week -3, week 87
Secondary outcome [88] 0 0
Change in Chloride (Week 34)
Timepoint [88] 0 0
Week -3, week 34
Secondary outcome [89] 0 0
Change in Chloride (Week 87)
Timepoint [89] 0 0
week -3, week 87
Secondary outcome [90] 0 0
Change in Creatinine (Week 34)
Timepoint [90] 0 0
Week -3, week 34
Secondary outcome [91] 0 0
Change in Creatinine (Week 87)
Timepoint [91] 0 0
week -3, week 87
Secondary outcome [92] 0 0
Change in Creatine Kinase (Week 34)
Timepoint [92] 0 0
Week -3, week 34
Secondary outcome [93] 0 0
Change in Creatine Kinase (Week 87)
Timepoint [93] 0 0
week -3, week 87
Secondary outcome [94] 0 0
Change in Gamma-glutamyl Transferase (GGT) (Week 34)
Timepoint [94] 0 0
Week -3, week 34
Secondary outcome [95] 0 0
Change in Gamma-glutamyl Transferase (GGT) (Week 87)
Timepoint [95] 0 0
week -3, week 87
Secondary outcome [96] 0 0
Change in Phosphate (Inorganic) (Week 34)
Timepoint [96] 0 0
Week -3, week 34
Secondary outcome [97] 0 0
Change in Phosphate (Inorganic)(Week 87)
Timepoint [97] 0 0
week -3, week 87
Secondary outcome [98] 0 0
Change in Potassium (Week 34)
Timepoint [98] 0 0
Week -3, week 34
Secondary outcome [99] 0 0
Change in Potassium (Week 87)
Timepoint [99] 0 0
week -3, week 87
Secondary outcome [100] 0 0
Change in Sodium (Week 34)
Timepoint [100] 0 0
Week -3, week 34
Secondary outcome [101] 0 0
Change in Sodium (Week 87)
Timepoint [101] 0 0
week -3, week 87
Secondary outcome [102] 0 0
Change in Total Protein (Week 34)
Timepoint [102] 0 0
Week -3, week 34
Secondary outcome [103] 0 0
Change in Total Protein (Week 87)
Timepoint [103] 0 0
week -3, week 87
Secondary outcome [104] 0 0
Change in Urea (Week 34)
Timepoint [104] 0 0
Week -3, week 34
Secondary outcome [105] 0 0
Change in Urea (Week 87)
Timepoint [105] 0 0
week -3, week 87
Secondary outcome [106] 0 0
Change in Uric Acid (Week 34)
Timepoint [106] 0 0
Week -3, week 34
Secondary outcome [107] 0 0
Change in Uric Acid (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)
Timepoint [108] 0 0
Week -3, week 34
Secondary outcome [109] 0 0
Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)
Timepoint [109] 0 0
week -3, week 87
Secondary outcome [110] 0 0
Change in Fasting Plasma Glucose (Week 34)
Timepoint [110] 0 0
Week -3, week 34
Secondary outcome [111] 0 0
Change in Fasting Plasma Glucose (Week 87)
Timepoint [111] 0 0
week -3, week 87
Secondary outcome [112] 0 0
Change in Fasting Insulin (Week 34)
Timepoint [112] 0 0
Week -3, week 34
Secondary outcome [113] 0 0
Change in Fasting Insulin (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)
Timepoint [114] 0 0
Week -3, week 34
Secondary outcome [115] 0 0
Change in Steady State Beta Cell Function (%B) (Week 87)
Timepoint [115] 0 0
week -3, week 87
Secondary outcome [116] 0 0
Change in Insulin Resistance (IR %) (Week 34)
Timepoint [116] 0 0
Week -3, week 34
Secondary outcome [117] 0 0
Change in Insulin Resistance (IR %) (Week 87)
Timepoint [117] 0 0
week -3, week 87
Secondary outcome [118] 0 0
Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)
Timepoint [118] 0 0
Week -3, week 34
Secondary outcome [119] 0 0
Change in Glycated Haemoglobin (HbA1c) (%) (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
Sex
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
31/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2018
Sample size
Target
Accrual to date
Final
301
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/study/NCT02229851
Trial related presentations / publications
Johannsson G, Gordon MB, Hojby Rasmussen M, Hakonsson IH, Karges W, Svaerke C, Tahara S, Takano K, Biller BMK. Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1358-76. doi: 10.1210/clinem/dgaa049.
Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02229851