Growth Hormone DeficiencyNCT06709040
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
An observational study of Growth Hormone Deficiency and Neoplasms, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
The aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Growth Hormone Deficiency, Neoplasms, Diabetes Mellitus Type 2
- What is being tested?
- Somapacitan
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2024to 14 Apr 2034
- 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 18 years
- All sexes
- Child, Adult
Study population: Paediatric participants with growth hormone deficiency
Who may be able to join
- Treated with commercially available somapacitan according to local practice at the discretion of the physician.
- Primary confirmed diagnosis of growth hormone deficiency as per local practice.
- Male or female below 18 years of age at the time of signing informed consent in the GLoBE-Reg.
Who cannot join
- Participants with active malignancy or in treatment for active pre-existing malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical Practice
The aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions. The study population will include 400 paediatric growth hormone deficient participants from the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (GloBE-Reg) treated with once-weekly somapacitan and fulfilling the eligibility criteria of the study. The total duration of the study is planned to 10 years consisting of a 5-year recruitment period in the GLoBE-Reg followed by a 5-year follow-up period.
- Being tested
- Somapacitan
- Medical subject headings
- Dwarfism, Pituitary, Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomapacitanDrug
Participants will be treated with commercially available somapacitan according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Growth Hormone Deficieny | The study is non-interventional as there are no interventions involved and decision to treat participants with commerically available somapacitan will be made at the treating physician's discretion prior to, and independently from, the decision to include the participants in the GLoBE-Reg registry. Novo Nordisk will not provide any products for included participants during the conduct of the study. Receives: Drug: Somapacitan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse drug reactions
Measured as count of events.
Measured: From baseline (week 0) to end of study (up to 10 years)
Secondary outcomes (11)
Number of medication errors (incorrect dose administration)
Measured as count of errors.
Measured: From baseline (week 0) to end of study (up to 10 years)
Number of participants with incident neoplasm
Measured as number of participants (yes/no).
Measured: From baseline (week 0) to end of study (up to 10 years)
Number of participants with incident diabetes mellitus type 2
Measured as number of participants (yes/no).
Measured: From baseline (week 0) to end of study (up to 10 years)
Height velocity
measured as centimeter per year (cm/year).
Measured: From baseline (week 0) to end of study (up to 10 years)
Change in height velocity standard deviation score (HVSDS)
Measured as score ranging from -10 to +10.
Measured: From baseline (week 0) to end of study (up to 10 years)
Change in height standard deviation score (HSDS)
Measured as score ranging from -10 to +10.
Measured: From baseline (week 0) to end of study (up to 10 years)
Change in insulin-like growth factor I (IGF-I) standard deviation score (SDS)
Measured as score ranging from -10 to +10.
Measured: From baseline (week 0) to end of study (up to 10 years)
Change in bone age (measured as years)
Measured as years.
Measured: From baseline (week 0) to end of study (up to 10 years)
Change in bone age (measured as months)
Measured as months.
Measured: From baseline (week 0) to end of study (up to 10 years)
Participants reaching near adult height
Near adult height defined as: height velocity <2 cm/year over the last 9 months and chronological age >16 years (males) or >15 years (females) or bone age >16 years (males) and > 15 years (females). Measured as number of participants (yes/no). Only for those who are expected to reach near adult height during the study.
Measured: at 10 year
Change in height SDS in participants reaching near adult height
Near adult height can be defined as: height velocity <2 cm/year over the last 9 months and chronological age >16 years (males) or >15 years (females) or bone age >16 years (males) and > 15 years (females). Measured as score ranging from -10 to +10. Only for those who are expected to reach near adult height during the study.
Measured: From baseline (week 0) to end of study (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start13 Dec 2024
- Primary completion14 Apr 2034 (estimated)
- Study completion14 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709040
- Sponsor's protocol ID
- NN8640-4787
- Other IDs
- U1111-1294-5941
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT06709040
- Acronym / sponsor ID
- NN8640-4787
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 14 Apr 2034 (estimated)
- Study completion
- 14 Apr 2034 (estimated)
- First posted
- 29 Nov 2024 (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 aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions. The study population will include 400 paediatric growth hormone deficient participants from the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (GloBE-Reg) treated with once-weekly somapacitan and fulfilling the eligibility criteria of the study. The total duration of the study is planned to 10 years consisting of a 5-year recruitment period in the GLoBE-Reg followed by a 5-year follow-up period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Growth Hormone Deficieny | – | Drug: SomapacitanThe study is non-interventional as there are no interventions involved and decision to treat participants with commerically available somapacitan will be made at the treating physician's discretion prior to, and independently from, the decision to include the participants in the GLoBE-Reg registry. Novo Nordisk will not provide any products for included participants during the conduct of the study. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Paediatric participants with growth hormone deficiency
Key inclusion criteria (3 listed)
- Treated with commercially available somapacitan according to local practice at the discretion of the physician.
- Primary confirmed diagnosis of growth hormone deficiency as per local practice.
- Male or female below 18 years of age at the time of signing informed consent in the GLoBE-Reg.
Key exclusion criteria (1 listed)
- Participants with active malignancy or in treatment for active pre-existing malignancy.
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 |
|---|---|---|
| SomapacitanParticipants will be treated with commercially available somapacitan according to routine clinical practice at the discretion of the treating physician. | Drug | Participants with Growth Hormone Deficieny |
Primary outcome
Number of adverse drug reactions
Time frame: From baseline (week 0) to end of study (up to 10 years)
Measured as count of events.
11 secondary outcomes
Number of medication errors (incorrect dose administration)
Time frame: From baseline (week 0) to end of study (up to 10 years)
Number of participants with incident neoplasm
Time frame: From baseline (week 0) to end of study (up to 10 years)
Number of participants with incident diabetes mellitus type 2
Time frame: From baseline (week 0) to end of study (up to 10 years)
Height velocity
Time frame: From baseline (week 0) to end of study (up to 10 years)
Change in height velocity standard deviation score (HVSDS)
Time frame: From baseline (week 0) to end of study (up to 10 years)
Change in height standard deviation score (HSDS)
Time frame: From baseline (week 0) to end of study (up to 10 years)
Change in insulin-like growth factor I (IGF-I) standard deviation score (SDS)
Time frame: From baseline (week 0) to end of study (up to 10 years)
Change in bone age (measured as years)
Time frame: From baseline (week 0) to end of study (up to 10 years)
Change in bone age (measured as months)
Time frame: From baseline (week 0) to end of study (up to 10 years)
Participants reaching near adult height
Time frame: at 10 year
Change in height SDS in participants reaching near adult height
Time frame: From baseline (week 0) to end of study (up to 10 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 6 Apr 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Related trials for Growth Hormone Deficiency
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
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 and Neoplasms, run by Novo Nordisk A/S at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 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 United Kingdom. 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?
Number of adverse drug reactions (time frame: From baseline (week 0) to end of study (up to 10 years)). 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 6 Apr 2026.