Clinical trial NCT03075644: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-03-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is 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.


Eligibility 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

Primary outcomes:
measure: Incidence of Adverse Events, Including Injection Site Reactions
timeFrame: Weeks 0-53
Secondary outcomes:
measure: Change in Cross-sectional Total Adipose Tissue Compartments
timeFrame: Week 0, week 52
measure: Change in Subcutaneous Adipose Tissue Compartments
timeFrame: Week 0, week 52
measure: Change in Intra-abdominal or Visceral Adipose Tissue Compartments
timeFrame: Week 0, week 52
measure: Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
timeFrame: Week 0, week 52
measure: Change in Physical Examination
timeFrame: Week 0, week 52
measure: Change in Body Weight
timeFrame: Week -3, week 52
measure: Change in SBP and DBP
timeFrame: Week 0, week 52
measure: Change in Pulse
timeFrame: Week 0, week 52
measure: Change in ECG
timeFrame: Week -3, week 52
measure: Change in Haematology: Haemoglobin
timeFrame: Week -3, week 52
measure: Change in Haematology: Haematocrit
timeFrame: Week -3, week 52
measure: Change in Haematology: Thrombocytes, Leucocytes
timeFrame: Week -3, week 52
measure: Change in Haematology: Erythrocytes
timeFrame: Week -3, week 52
measure: Change in Haematology: Mean Corpuscular Volume
timeFrame: Week -3, week 52
measure: Change in Haematology: Mean Corpuscular Haemoglobin Concentration
timeFrame: Week -3, week 52
measure: Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total)
timeFrame: Week -3, week 52
measure: Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT
timeFrame: Week -3, week 52
measure: Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total)
timeFrame: Week -3, week 52
measure: Change in Biochemistry: Total Protein and Albumin
timeFrame: Week -3, week 52
measure: Change in Biochemistry: eGFR Creatinine
timeFrame: Week -3, week 52
measure: Change in HbA1c
timeFrame: Week -3, week 52
measure: Change in FPG
timeFrame: Week -3, week 52
measure: Change in Fasting Insulin
timeFrame: Week -3, week 52
measure: Change in Steady State Beta Cell Function
timeFrame: Week -3, week 52
measure: Change in Insulin Resistance
timeFrame: Week -3, week 52
measure: Occurrence of Anti-somapacitan Antibodies
timeFrame: Weeks 0 - 53
measure: Occurrence of Anti-hGH Antibodies
timeFrame: Weeks 0 - 53
measure: Incidence of Clinical Technical Complaints
timeFrame: Weeks 0 - 53
Other outcomes:
Locations:
city: Bunkyo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chiba-shi, Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kagoshima
country: Japan
facility: Novo Nordisk Investigational Site
city: Kobe, Hyogo
country: Japan
facility: Novo Nordisk Investigational Site
city: Kyoto-shi Kyoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Okayama, Okayama
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Sagamihara-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Yamagata-shi, Yamagata
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Otsuka F, Takahashi Y, Tahara S, Ogawa Y, Hojby Rasmussen M, Takano K. Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone. Clin Endocrinol (Oxf). 2020 Nov;93(5):620-628. doi: 10.1111/cen.14273. Epub 2020 Aug 14.
citation: Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.