Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)

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

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