A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03075644
• Date of registration: 28/02/2017
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
• Scientific title: A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
• Date of first enrolment: March 3, 2017
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03075644
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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 - GHD diagnosed for at least 6 months
(defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive
months (defined as 180 days) 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:1/ Resected in situ
carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete
local excision 2/ Subjects with GHD 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 medical records - For subjects 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 magnetic resonance imaging (MRI) scans 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



Age minimum: 18 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Disorder

Adult Growth Hormone Deficiency

Intervention(s)

Drug: somapacitan

Drug: Norditropin

Primary Outcome(s)

Incidence of Adverse Events, Including Injection Site Reactions [Time Frame: Weeks 0-53]

Secondary Outcome(s)

Change in Haematology: Haematocrit [Time Frame: Week -3, week 52]

Change in SBP and DBP [Time Frame: Week 0, week 52]

Change in Fasting Insulin [Time Frame: Week -3, week 52]

Change in Haematology: Mean Corpuscular Volume [Time Frame: Week -3, week 52]

Change in Body Weight [Time Frame: Week -3, week 52]

Change in Intra-abdominal or Visceral Adipose Tissue Compartments [Time Frame: Week 0, week 52]

Change in Haematology: Erythrocytes [Time Frame: Week -3, week 52]

Change in Physical Examination [Time Frame: Week 0, week 52]

Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) [Time Frame: Week -3, week 52]

Change in Biochemistry: Total Protein and Albumin [Time Frame: Week -3, week 52]

Change in Pulse [Time Frame: Week 0, week 52]

Change in Subcutaneous Adipose Tissue Compartments [Time Frame: Week 0, week 52]

Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT [Time Frame: Week -3, week 52]

Change in Cross-sectional Total Adipose Tissue Compartments [Time Frame: Week 0, week 52]

Change in Haematology: Haemoglobin [Time Frame: Week -3, week 52]

Change in Haematology: Thrombocytes, Leucocytes [Time Frame: Week -3, week 52]

Change in ECG [Time Frame: Week -3, week 52]

Occurrence of Anti-hGH Antibodies [Time Frame: Weeks 0 - 53]

Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores [Time Frame: Week 0, week 52]

Change in Haematology: Mean Corpuscular Haemoglobin Concentration [Time Frame: Week -3, week 52]

Change in Biochemistry: eGFR Creatinine [Time Frame: Week -3, week 52]

Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) [Time Frame: Week -3, week 52]

Change in FPG [Time Frame: Week -3, week 52]

Change in HbA1c [Time Frame: Week -3, week 52]

Change in Insulin Resistance [Time Frame: Week -3, week 52]

Change in Steady State Beta Cell Function [Time Frame: Week -3, week 52]

Incidence of Clinical Technical Complaints [Time Frame: Weeks 0 - 53]

Occurrence of Anti-somapacitan Antibodies [Time Frame: Weeks 0 - 53]

Secondary ID(s)

NN8640-4244

JapicCTI-173534

U1111-1181-1618

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03075644