Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
Brief summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
Interventions
DRUGNNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
DRUGplacebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II * Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion * GH replacement therapy for more than 3 months * Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive
Exclusion criteria
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods * Malignant disease * Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes * Heart insufficiency, NYHA class greater than 2 * Subjects with diabetes with an HbA1C above 8.0% * Diabetic receiving insulin treatment * Stable pituitary replacement therapy for less than 3 months * Impaired liver function * Impaired kidney function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability (adverse events, local tolerability, physical examination) | 0 to 10 days after third dosing, (day 15-25 after first dose) |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, maximum concentration of IGF-I | after trial product administration |
Countries
Denmark
Outcome results
None listed