Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
Brief summary
This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the effect of NN-220 compared with that of placebo as assessed by the change in percent in truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with Growth Hormone Deficiency in Adults (GHDA).
Interventions
DRUGsomatropin
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with diagnosed GHD * If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded * Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies
Exclusion criteria
* Subject with a history of acromegaly * Subject with diabetes mellitus * Subject suffering from malignancy * Several medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in truncal fat (kg) from baseline | at 24 weeks (end of treatment) |
Secondary
| Measure | Time frame |
|---|---|
| Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) | — |
| IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio | — |
| Change in total body fat, total LBM, etc. from baseline to 24 weeks | — |
| Clinical laboratory tests | — |
| FPG, insulin, and HbA1c | — |
| Adverse events | — |
Countries
Japan
Outcome results
None listed