A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).

Inclusion Criteria:

• Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD
• Stable human growth hormone (hGH) replacement therapy for at least 3 months

Exclusion Criteria:

• Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation
• Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix
• Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
• Heart insufficiency, New York Heart Association (NYHA) class above 2
• Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment
• Stable pituitary replacement therapy for less than 3 months