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Growth Hormone DisorderPhase 3NCT03075644

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

A Phase 3 study testing somapacitan and Norditropin in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
somapacitan and Norditropin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
12 sitesJapan
Study dates
3 Mar 2017to 4 Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Novo Nordisk Investigational Site

    Bunkyo-ku, Tokyo, 113-8603

  • Novo Nordisk Investigational Site

    Chiba-shi, Chiba, 260-8677

  • Novo Nordisk Investigational Site

    Fukuoka, 818 8502

  • Novo Nordisk Investigational Site

    Kagoshima, 890-8520

  • Novo Nordisk Investigational Site

    Kobe, Hyogo, 650-0017

  • Novo Nordisk Investigational Site

    Kyoto-shi Kyoto, 612-8555

  • Novo Nordisk Investigational Site

    Okayama, Okayama, 700-8558

  • Novo Nordisk Investigational Site

    Osaka, 565-0871

  • Novo Nordisk Investigational Site

    Sagamihara-shi, Kanagawa, 252-0375

  • Novo Nordisk Investigational Site

    Tokyo, 134-0088

  • Novo Nordisk Investigational Site

    Yamagata-shi, Yamagata, 990-9585

  • Novo Nordisk Investigational Site

    Yokohama, Kanagawa, 222-0036

Other trials in Japan

About this study

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

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.

Being tested
somapacitan, Norditropin
Medical subject headings
Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • somapacitanDrug

    Once weekly subcutaneous injections (s.c., under the skin)

  • NorditropinDrug

    Daily subcutaneous injections (s.c., under the skin)

Study groups in NCT03075644
Study groupRoleWhat they receive
SomapacitanExperimentalNot described
Receives: Drug: somapacitan
NorditropinActive comparatorNot described
Receives: Drug: Norditropin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events, Including Injection Site Reactions

    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.

    Measured: Weeks 0-53

Secondary outcomes (28)

  1. Change in Cross-sectional Total Adipose Tissue Compartments

    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.

    Measured: Week 0, week 52

  2. Change in Subcutaneous Adipose Tissue Compartments

    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.

    Measured: Week 0, week 52

  3. Change in Intra-abdominal or Visceral Adipose Tissue Compartments

    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.

    Measured: Week 0, week 52

  4. Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores

    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.

    Measured: Week 0, week 52

  5. Change in Physical Examination

    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.

    Measured: Week 0, week 52

  6. Change in Body Weight

    Change from baseline (week -3) in body weight at week 52 is presented.

    Measured: Week -3, week 52

  7. Change in SBP and DBP

    Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented.

    Measured: Week 0, week 52

  8. Change in Pulse

    Change from baseline (week 0) in pulse at week 52 is presented.

    Measured: Week 0, week 52

  9. Change in ECG

    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.

    Measured: Week -3, week 52

  10. Change in Haematology: Haemoglobin

    Change from baseline (week -3) in haemoglobin at week 52 is presented.

    Measured: Week -3, week 52

  11. Change in Haematology: Haematocrit

    Change from baseline (week -3) in haematocrit at week 52 is presented.

    Measured: Week -3, week 52

  12. Change in Haematology: Thrombocytes, Leucocytes

    Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented.

    Measured: Week -3, week 52

  13. Change in Haematology: Erythrocytes

    Change from baseline (week -3) in erythrocytes at week 52 is presented.

    Measured: Week -3, week 52

  14. Change in Haematology: Mean Corpuscular Volume

    Change from baseline (week -3) in mean corpuscular volume at week 52 is presented.

    Measured: Week -3, week 52

  15. Change in Haematology: Mean Corpuscular Haemoglobin Concentration

    Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented.

    Measured: Week -3, week 52

  16. Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total)

    Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented.

    Measured: Week -3, week 52

  17. Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT

    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.

    Measured: Week -3, week 52

  18. Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total)

    Change from baseline (week -3) in urea, sodium, potassium, chloride, phosphate (inorganic), calcium (total) (mmol/L) at week 52 is presented.

    Measured: Week -3, week 52

  19. Change in Biochemistry: Total Protein and Albumin

    Change from baseline (week -3) in total protein and albumin at week 52 is presented.

    Measured: Week -3, week 52

  20. Change in Biochemistry: eGFR Creatinine

    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.

    Measured: Week -3, week 52

  21. Change in HbA1c

    Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented.

    Measured: Week -3, week 52

  22. Change in FPG

    Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented.

    Measured: Week -3, week 52

  23. Change in Fasting Insulin

    Change from baseline (week -3) in fasting insulin at week 52 is presented.

    Measured: Week -3, week 52

  24. Change in Steady State Beta Cell Function

    Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented.

    Measured: Week -3, week 52

  25. Change in Insulin Resistance

    Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented.

    Measured: Week -3, week 52

  26. Occurrence of Anti-somapacitan Antibodies

    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".

    Measured: Weeks 0 - 53

  27. Occurrence of Anti-hGH Antibodies

    Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented.

    Measured: Weeks 0 - 53

  28. Incidence of Clinical Technical Complaints

    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.

    Measured: Weeks 0 - 53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2017
  2. Study start3 Mar 2017
  3. Primary completion4 Oct 2018
  4. Study completion4 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03075644
Sponsor's protocol ID
NN8640-4244
Other IDs
U1111-1181-1618, JapicCTI-173534
Status last verified
Nov 2020
First submitted
28 Feb 2017
Last updated
23 Nov 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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.

    PubMed 32603494

  • 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.

    PubMed 36380045

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing somapacitan and Norditropin in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Including Injection Site Reactions (time frame: Weeks 0-53). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03075644, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.

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