DRUG
somapacitan
Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.
Status
Completed
Phase
Phase 3
Enrollment
92
Locations
28
Results
Posted
Publications
1
Study summary
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.
Interventions
DRUG
Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.
DRUG
Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.
Timeline
First posted
Mar 9, 2015
Study start
Feb 12, 2015
Primary completion
Jan 4, 2016
Study completion
Jan 4, 2016
Results posted
Jun 16, 2020
Registry updated
Jul 9, 2020
Outcomes
Incidence of Adverse Events
Time frame · Weeks 0 - 26
An adverse event can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Presented results are event rate per 100 patient years of exposure.
Incidence of Injection Site Reactions
Time frame · Weeks 0- 26
Presented results are event (injection site reaction) rate per 100 patient years of exposure.
Occurrence of Anti-NNC0195-0092 Antibodies
Time frame · At week 0 (baseline), and at week 2, 4, 8, 16, 25 and 27
Number of participants with anti-somapacitan (NNC0195-0092) antibodies are presented.
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores (Effectiveness,Convenience, and Global Satisfaction Scores)
Time frame · Baseline (week 0), week 26
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. Items are rated on a 5 or 7-point scale according to participants' experience with the medication. Each domain score can vary from 0 to 100 with higher scores indicating higher effectiveness of treatment, more convenient use of medication and overall greater satisfaction with the treatment.
Eligibility
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
Study locations
Denmark · France · Germany · Japan · Sweden · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
Novo Nordisk Investigational Site
Århus C, Denmark
Novo Nordisk Investigational Site
København Ø, Denmark
Novo Nordisk Investigational Site
Odense, Denmark
Novo Nordisk Investigational Site
Angers, France
Novo Nordisk Investigational Site
Brest, France
Novo Nordisk Investigational Site
Bron, France
Novo Nordisk Investigational Site
Dijon, France
Novo Nordisk Investigational Site
Saint-Herblain, France
Novo Nordisk Investigational Site
Aachen, Germany
Novo Nordisk Investigational Site
Berlin, Germany
Novo Nordisk Investigational Site
Frankfurt, Germany
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Izumo, Shimane, Japan
Novo Nordisk Investigational Site
Kobe, Hyogo, Japan
Novo Nordisk Investigational Site
Kobe-shi, Hyogo, Japan
Novo Nordisk Investigational Site
Kyoto-shi Kyoto, Japan
Novo Nordisk Investigational Site
Okayama, Okayama, Japan
Novo Nordisk Investigational Site
Sagamihara-shi, Kanagawa, Japan
Novo Nordisk Investigational Site
Gothenburg, Sweden
Novo Nordisk Investigational Site
Lund, Sweden
Novo Nordisk Investigational Site
Stockholm, Sweden
Novo Nordisk Investigational Site
Birmingham, United Kingdom
Novo Nordisk Investigational Site
Exeter, United Kingdom
Publications
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