Growth Hormone Deficiency Without Epiphyseal ClosureNCT05602766
Ngenla Subcutaneous Injection Special Investigation
An observational study of Growth Hormone Deficiency Without Epiphyseal Closure, run by Pfizer at 1 site in Japan.
Trial summary
The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Growth Hormone Deficiency Without Epiphyseal Closure
- What is being tested?
- NGENLA (Somatrogon)
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- 6 Feb 2023to 6 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with GHD without epiphyseal closure who received NGENLA
Patients who satisfy all of the registration criteria are subject to this study.
Registration criteria
- Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study.
- Boys who are less than 15 years and girls who are less than 13 years of chronological age at the start of treatment with this drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ngenla® Subcutaneous Injection Special Investigation
The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.
Registration criteria of this study are the patients who:
Read more
- Have GHD without epiphyseal closure and receiving Ngenla for the first time.
- Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.
All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.
Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.
Read the detailed description
This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.
- Being tested
- NGENLA (Somatrogon)
- Keywords
- Growth hormone deficiency (GHD), Recombinant human growth hormone (hGH), once-weekly injection, Somatrogon
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGENLA (Somatrogon)Drug
Dosage, Frequency: Refer to the latest package insert.
| Study group | Role | What they receive |
|---|---|---|
| NGENLA (Somatrogon) | Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon) Receives: Drug: NGENLA (Somatrogon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients reporting Adverse Events (AEs)
Measured: up to 5 years
Incidence of Glucose metabolism disorders per exposure period
Measured: up to 5 years
Incidence of Neoplasm per exposure period
Measured: up to 5 years
Annual growth rate (cm/year)
Measured: up to 5 years
Growth rate standard deviation score (SDS) for chronological age
Measured: up to 5 years
Change in height SDS for chronological age and time-course of height SDS for chronological age
Measured: up to 5 years
Proportion of reported Adverse Events
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start6 Feb 2023
- Primary completion6 Apr 2029 (estimated)
- Study completion6 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone Deficiency Without Epiphyseal ClosureStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602766
- Sponsor's protocol ID
- C0311011
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ngenla® Subcutaneous Injection Special Investigation
- ClinicalTrials.gov ID
- NCT05602766
- Acronym / sponsor ID
- C0311011
- Keywords
- Growth hormone deficiency (GHD), Recombinant human growth hormone (hGH), once-weekly injection, Somatrogon
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 6 Apr 2029 (estimated)
- Study completion
- 6 Apr 2029 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.
Registration criteria of this study are the patients who:
- Have GHD without epiphyseal closure and receiving Ngenla for the first time.
- Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.
All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.
Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.
Detailed description
This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGENLA (Somatrogon) | – | Drug: NGENLA (Somatrogon)Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon) |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with GHD without epiphyseal closure who received NGENLA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGENLA (Somatrogon)Dosage, Frequency: Refer to the latest package insert. | Drug | NGENLA (Somatrogon) |
Primary outcome
The number of patients reporting Adverse Events (AEs)
Time frame: up to 5 years
Incidence of Glucose metabolism disorders per exposure period
Time frame: up to 5 years
Incidence of Neoplasm per exposure period
Time frame: up to 5 years
Annual growth rate (cm/year)
Time frame: up to 5 years
Growth rate standard deviation score (SDS) for chronological age
Time frame: up to 5 years
Change in height SDS for chronological age and time-course of height SDS for chronological age
Time frame: up to 5 years
Proportion of reported Adverse Events
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency Without Epiphyseal Closure, run by Pfizer at 1 site 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The number of patients reporting Adverse Events (AEs) (time frame: up to 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.