- ICH GCP
- US Clinical Trials Registry
- 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
November 3, 2020 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bunkyo-ku, Tokyo, Japan, 113-8603
- Novo Nordisk Investigational Site
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Chiba-shi, Chiba, Japan, 260-8677
- Novo Nordisk Investigational Site
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Fukuoka, Japan, 818 8502
- Novo Nordisk Investigational Site
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Kagoshima, Japan, 890-8520
- Novo Nordisk Investigational Site
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Kobe, Hyogo, Japan, 650-0017
- Novo Nordisk Investigational Site
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Kyoto-shi Kyoto, Japan, 612-8555
- Novo Nordisk Investigational Site
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Okayama, Okayama, Japan, 700-8558
- Novo Nordisk Investigational Site
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Osaka, Japan, 565-0871
- Novo Nordisk Investigational Site
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Sagamihara-shi, Kanagawa, Japan, 252-0375
- Novo Nordisk Investigational Site
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Tokyo, Japan, 134-0088
- Novo Nordisk Investigational Site
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Yamagata-shi, Yamagata, Japan, 990-9585
- Novo Nordisk Investigational Site
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Yokohama, Kanagawa, Japan, 222-0036
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Somapacitan
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Once weekly subcutaneous injections (s.c., under the skin)
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Active Comparator: Norditropin
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Daily subcutaneous injections (s.c., under the skin)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events, Including Injection Site Reactions
Time Frame: Weeks 0-53
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An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment.
Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented.
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Weeks 0-53
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cross-sectional Total Adipose Tissue Compartments
Time Frame: Week 0, week 52
|
Cross-sectional total adipose tissue compartments (TAT) were determined by quantitative computed tomography (CT) scans.
Change from baseline (week 0) to end of treatment period (52 weeks) in cross-sectional TAT compartments is presented.
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Week 0, week 52
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Change in Subcutaneous Adipose Tissue Compartments
Time Frame: Week 0, week 52
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Subcutaneous adipose tissue compartments (SAT) was determined by quantitative CT scans.
Change from baseline (week 0) to end of treatment period (52 weeks) in SAT compartments is presented.
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Week 0, week 52
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Change in Intra-abdominal or Visceral Adipose Tissue Compartments
Time Frame: Week 0, week 52
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Intra-abdominal or visceral adipose tissue (VAT) compartments was determined by quantitative CT scans.
Change from baseline (week 0) to end of treatment period (52 weeks) in VAT compartments is presented.
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Week 0, week 52
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Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Time Frame: Week 0, week 52
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The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication.
Items are rated on a 5-point or 7-point scale according to patients' experience with the medication.
The items covered are satisfaction with the effectiveness of the medication, convenience and global satisfaction of treatment.
Each domain is based on 3 questions.
The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome.
Scores have been summed and then scaled to 0-100.
Change in TSQM-9 scores from baseline (week 0) to week 52 are presented.
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Week 0, week 52
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Change in Physical Examination
Time Frame: Week 0, week 52
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Physical examination parameters were evaluated for head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system, gastrointestinal system, incl.
mouth; musculoskeletal system; nervous system (central and peripheral); skin; and lymph node palpation.
The investigator evaluated the findings from the physical examination and classifies them as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS).
Results are presented for week 0 and week 52.
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Week 0, week 52
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Change in Body Weight
Time Frame: Week -3, week 52
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Change from baseline (week -3) in body weight at week 52 is presented.
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Week -3, week 52
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Change in SBP and DBP
Time Frame: Week 0, week 52
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Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented.
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Week 0, week 52
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Change in Pulse
Time Frame: Week 0, week 52
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Change from baseline (week 0) in pulse at week 52 is presented.
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Week 0, week 52
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Change in ECG
Time Frame: Week -3, week 52
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The ECG was assessed by the investigator at baseline (week -3) and week 52 and categorised as normal, abnormal NCS or abnormal CS.
Number of participants in each ECG category at week -3 and week 52 are presented.
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Week -3, week 52
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Change in Haematology: Haemoglobin
Time Frame: Week -3, week 52
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Change from baseline (week -3) in haemoglobin at week 52 is presented.
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Week -3, week 52
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Change in Haematology: Haematocrit
Time Frame: Week -3, week 52
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Change from baseline (week -3) in haematocrit at week 52 is presented.
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Week -3, week 52
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Change in Haematology: Thrombocytes, Leucocytes
Time Frame: Week -3, week 52
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Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented.
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Week -3, week 52
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Change in Haematology: Erythrocytes
Time Frame: Week -3, week 52
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Change from baseline (week -3) in erythrocytes at week 52 is presented.
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Week -3, week 52
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Change in Haematology: Mean Corpuscular Volume
Time Frame: Week -3, week 52
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Change from baseline (week -3) in mean corpuscular volume at week 52 is presented.
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Week -3, week 52
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Change in Haematology: Mean Corpuscular Haemoglobin Concentration
Time Frame: Week -3, week 52
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Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented.
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Week -3, week 52
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Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total)
Time Frame: Week -3, week 52
|
Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented.
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Week -3, week 52
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Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT
Time Frame: Week -3, week 52
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Change from baseline (week -3) in creatinine kinase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at week 52 is presented.
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Week -3, week 52
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Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total)
Time Frame: Week -3, week 52
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Change from baseline (week -3) in urea, sodium, potassium, chloride, phosphate (inorganic), calcium (total) (mmol/L) at week 52 is presented.
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Week -3, week 52
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Change in Biochemistry: Total Protein and Albumin
Time Frame: Week -3, week 52
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Change from baseline (week -3) in total protein and albumin at week 52 is presented.
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Week -3, week 52
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Change in Biochemistry: eGFR Creatinine
Time Frame: Week -3, week 52
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Estimated glomerular filtration rate (eGFR) creatinine (measured in milliliters per minute per 1.73 square meters [mL/min/1.73m^2])
was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Change from baseline (week -3) in eGFR at week 52 is presented.
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Week -3, week 52
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Change in HbA1c
Time Frame: Week -3, week 52
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Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented.
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Week -3, week 52
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Change in FPG
Time Frame: Week -3, week 52
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Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented.
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Week -3, week 52
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Change in Fasting Insulin
Time Frame: Week -3, week 52
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Change from baseline (week -3) in fasting insulin at week 52 is presented.
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Week -3, week 52
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Change in Steady State Beta Cell Function
Time Frame: Week -3, week 52
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Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented.
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Week -3, week 52
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Change in Insulin Resistance
Time Frame: Week -3, week 52
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Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented.
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Week -3, week 52
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Occurrence of Anti-somapacitan Antibodies
Time Frame: Weeks 0 - 53
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Number of participants with anti-somapacitan antibodies at baseline (week 0) and week 53 are presented.
This outcome measure is applicable only for the treatment arm "Somapacitan".
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Weeks 0 - 53
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Occurrence of Anti-hGH Antibodies
Time Frame: Weeks 0 - 53
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Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented.
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Weeks 0 - 53
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Incidence of Clinical Technical Complaints
Time Frame: Weeks 0 - 53
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A technical complaint was any written, electronic, or oral communication that alleged product (medicine or device) defects.
Number of partipants who reported technical complaints during the course of the trial are presented.
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Weeks 0 - 53
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. 2022 Nov 15. doi: 10.1007/s11102-022-01283-3. Online ahead of print.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2017
Primary Completion (Actual)
October 4, 2018
Study Completion (Actual)
October 4, 2018
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
March 7, 2017
First Posted (Actual)
March 9, 2017
Study Record Updates
Last Update Posted (Actual)
November 23, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN8640-4244
- U1111-1181-1618 (Other Identifier: World Health Organization (WHO))
- JapicCTI-173534 (Registry Identifier: JAPIC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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