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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT03075644 (opens ClinicalTrials.gov in a new tab)Other idNN8640-4244Other idU1111-1181-1618Other idJapicCTI-173534
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
62 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
3 Mar 2017
Primary completion
4 Oct 2018
Completion
4 Oct 2018
First posted
9 Mar 2017
Last update posted
23 Nov 2020
Conditions
Growth Hormone Disorder · Adult Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 3

    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

    NCT03075644

    3 Mar 2017 to 4 Oct 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • somapacitanDrug
  • NorditropinDrug

Arms2

  • Experimental

    Somapacitan

  • Active comparator

    Norditropin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of Adverse Events, Including Injection Site Reactions

    Time frame · Weeks 0-53

    Registry description

    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.

Secondary outcomes(20)

  1. Change in Cross-sectional Total Adipose Tissue Compartments

    Time frame · Week 0, week 52

    Registry description

    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.

  2. Change in Subcutaneous Adipose Tissue Compartments

    Time frame · Week 0, week 52

    Registry description

    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.

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

    Time frame · Week 0, week 52

    Registry description

    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.

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

    Time frame · Week 0, week 52

    Registry description

    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.

  5. Change in Physical Examination

    Time frame · Week 0, week 52

    Registry description

    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.

  6. Change in Body Weight

    Time frame · Week -3, week 52

    Registry description

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

  7. Change in SBP and DBP

    Time frame · Week 0, week 52

    Registry description

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

  8. Change in Pulse

    Time frame · Week 0, week 52

    Registry description

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

  9. Change in ECG

    Time frame · Week -3, week 52

    Registry description

    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.

  10. Change in Haematology: Haemoglobin

    Time frame · Week -3, week 52

    Registry description

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

  11. Change in Haematology: Haematocrit

    Time frame · Week -3, week 52

    Registry description

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

  12. Change in Haematology: Thrombocytes, Leucocytes

    Time frame · Week -3, week 52

    Registry description

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

  13. Change in Haematology: Erythrocytes

    Time frame · Week -3, week 52

    Registry description

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

  14. Change in Haematology: Mean Corpuscular Volume

    Time frame · Week -3, week 52

    Registry description

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

  15. Change in Haematology: Mean Corpuscular Haemoglobin Concentration

    Time frame · Week -3, week 52

    Registry description

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

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

    Time frame · Week -3, week 52

    Registry description

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

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

    Time frame · Week -3, week 52

    Registry description

    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.

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

    Time frame · Week -3, week 52

    Registry description

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

  19. Change in Biochemistry: Total Protein and Albumin

    Time frame · Week -3, week 52

    Registry description

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

  20. Change in Biochemistry: eGFR Creatinine

    Time frame · Week -3, week 52

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Weeks 0-53

Incidence of Adverse Events, Including Injection Site Reactions

GroupValue (Event rate per 100 patient years)
Norditropin®309.8
Somapacitan312.7
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, week 52

Change in Cross-sectional Total Adipose Tissue Compartments

GroupValue (Square centimeters (cm^2))Spread
Norditropin®7.45032.177
Somapacitan-7.09158.893
Secondary outcomeMean· Week 0, week 52

Change in Subcutaneous Adipose Tissue Compartments

GroupValue (cm^2)Spread
Norditropin®6.77922.900
Somapacitan-5.03340.735
Secondary outcomeMean· Week 0, week 52

Change in Intra-abdominal or Visceral Adipose Tissue Compartments

GroupValue (cm^2)Spread
Norditropin®0.67115.284
Somapacitan-2.61829.123
Secondary outcomeMean· Week 0, week 52

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

GroupValue (Score on a scale)Spread
Norditropin®3.616.2
Somapacitan7.917.5
Secondary outcomeCount of participants· Week 0, week 52

Change in Physical Examination

GroupValue (Participants)
Norditropin®15
Somapacitan45
Secondary outcomeMean· Week -3, week 52

Change in Body Weight

GroupValue (Kilogram (Kg))Spread
Norditropin®0.662.50
Somapacitan-0.293.49
Secondary outcomeMean· Week 0, week 52

Change in SBP and DBP

GroupValue (Millimeters of mercury (mmHg))Spread
Norditropin®-3.114.8
Somapacitan-3.311.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Norditropin®Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).0 / 160 / 1611 / 16
SomapacitanParticipants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.0 / 464 / 4633 / 46

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2023

10 results

Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.

Takahashi et al. 2023Pituitarycited by 12

PMID 36380045PMC9908671DOI 10.1007/s11102-022-01283-3PUB-36380045

CC BY10 results
Download PDFSee results (10)

Indexing hint: Randomized controlled trial · 2020

7 results

Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.

Otsuka et al. 2020Clinical endocrinologycited by 34

PMID 32603494PMC7689735DOI 10.1111/cen.14273PUB-32603494

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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