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A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

Sponsored by Novo Nordisk A/S

About this trial

Last updated 5 years ago

Study ID

NN8640-4043

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 79 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.

What are the Participation Requirements?

Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79
years of age at the time of signing informed consent - Adult growth hormone deficiency
diagnosed for 6 months or longer (defined as 180 days) prior to screening - Treatment
with hGH (human growth hormone) for at least 6 months at screening - 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 Exclusion Criteria:
- Active malignant disease or history of malignancy. Exceptions to this exclusion
criterion: Resected in situ carcinoma of the cervix and squamous cell or basal cell
carcinoma of the skin with complete local excision. / Subjects with GHD (growth hormone
deficiency) 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 - For patients with surgical removal or debulking of pituitary adenoma or
other benign intracranial tumour within the last 5 years: Evidence of growth of pituitary
adenoma or other benign intracranial tumour within the last 12 months (defined as below
or equal to 365 days) before randomisation. Absence of growth must be documented by two
post-surgery MRI or CT scans. The most recent MRI or CT scan must be performed below or
equal to 9 months (defined as below or equal to 270 days) prior to randomisation

Locations

Location

Status