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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Japan
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Novo Nordisk Investigational Site
      • Chiba-shi, Chiba, Japan, 260-8677
        • Novo Nordisk Investigational Site
      • Fukuoka, Japan, 818 8502
        • Novo Nordisk Investigational Site
      • Kagoshima, Japan, 890-8520
        • Novo Nordisk Investigational Site
      • Kobe, Hyogo, Japan, 650-0017
        • Novo Nordisk Investigational Site
      • Kyoto-shi Kyoto, Japan, 612-8555
        • Novo Nordisk Investigational Site
      • Okayama, Okayama, Japan, 700-8558
        • Novo Nordisk Investigational Site
      • Osaka, Japan, 565-0871
        • Novo Nordisk Investigational Site
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 134-0088
        • Novo Nordisk Investigational Site
      • Yamagata-shi, Yamagata, Japan, 990-9585
        • Novo Nordisk Investigational Site
      • Yokohama, Kanagawa, Japan, 222-0036
        • Novo Nordisk Investigational Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Somapacitan
Drug: somapacitan
Once weekly subcutaneous injections (s.c., under the skin)
Active Comparator: Norditropin
Drug: Norditropin
Daily subcutaneous injections (s.c., under the skin)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events, Including Injection Site Reactions
Time Frame: Weeks 0-53
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.
Weeks 0-53

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Week 0, week 52
Change in Subcutaneous Adipose Tissue Compartments
Time Frame: Week 0, week 52
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.
Week 0, week 52
Change in Intra-abdominal or Visceral Adipose Tissue Compartments
Time Frame: Week 0, week 52
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.
Week 0, week 52
Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Time Frame: Week 0, week 52
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.
Week 0, week 52
Change in Physical Examination
Time Frame: Week 0, week 52
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.
Week 0, week 52
Change in Body Weight
Time Frame: Week -3, week 52
Change from baseline (week -3) in body weight at week 52 is presented.
Week -3, week 52
Change in SBP and DBP
Time Frame: Week 0, week 52
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented.
Week 0, week 52
Change in Pulse
Time Frame: Week 0, week 52
Change from baseline (week 0) in pulse at week 52 is presented.
Week 0, week 52
Change in ECG
Time Frame: Week -3, week 52
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.
Week -3, week 52
Change in Haematology: Haemoglobin
Time Frame: Week -3, week 52
Change from baseline (week -3) in haemoglobin at week 52 is presented.
Week -3, week 52
Change in Haematology: Haematocrit
Time Frame: Week -3, week 52
Change from baseline (week -3) in haematocrit at week 52 is presented.
Week -3, week 52
Change in Haematology: Thrombocytes, Leucocytes
Time Frame: Week -3, week 52
Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented.
Week -3, week 52
Change in Haematology: Erythrocytes
Time Frame: Week -3, week 52
Change from baseline (week -3) in erythrocytes at week 52 is presented.
Week -3, week 52
Change in Haematology: Mean Corpuscular Volume
Time Frame: Week -3, week 52
Change from baseline (week -3) in mean corpuscular volume at week 52 is presented.
Week -3, week 52
Change in Haematology: Mean Corpuscular Haemoglobin Concentration
Time Frame: Week -3, week 52
Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented.
Week -3, week 52
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.
Week -3, week 52
Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT
Time Frame: Week -3, week 52
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.
Week -3, week 52
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total)
Time Frame: Week -3, week 52
Change from baseline (week -3) in urea, sodium, potassium, chloride, phosphate (inorganic), calcium (total) (mmol/L) at week 52 is presented.
Week -3, week 52
Change in Biochemistry: Total Protein and Albumin
Time Frame: Week -3, week 52
Change from baseline (week -3) in total protein and albumin at week 52 is presented.
Week -3, week 52
Change in Biochemistry: eGFR Creatinine
Time Frame: Week -3, week 52
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.
Week -3, week 52
Change in HbA1c
Time Frame: Week -3, week 52
Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented.
Week -3, week 52
Change in FPG
Time Frame: Week -3, week 52
Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented.
Week -3, week 52
Change in Fasting Insulin
Time Frame: Week -3, week 52
Change from baseline (week -3) in fasting insulin at week 52 is presented.
Week -3, week 52
Change in Steady State Beta Cell Function
Time Frame: Week -3, week 52
Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented.
Week -3, week 52
Change in Insulin Resistance
Time Frame: Week -3, week 52
Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented.
Week -3, week 52
Occurrence of Anti-somapacitan Antibodies
Time Frame: Weeks 0 - 53
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".
Weeks 0 - 53
Occurrence of Anti-hGH Antibodies
Time Frame: Weeks 0 - 53
Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented.
Weeks 0 - 53
Incidence of Clinical Technical Complaints
Time Frame: Weeks 0 - 53
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.
Weeks 0 - 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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