Growth Hormone Deficiency in ChildrenPhase 3NCT04970654
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.
A Phase 3 study testing somapacitan and Norditropin® in people with Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 32 sites in China.
Trial summary
The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Hormone Deficiency in Children
- 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
- 110 participants
- Where
- 32 sitesChina
- Study dates
- 22 Jul 2021to 18 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent of parent or legally acceptable representative of participant and child assent, as age-appropriate must be obtained before any trial related activities
- The parent or legally acceptable representative of the child must sign and date the Informed consent form (according to local requirements)
- The child must sign and date child assent form or provide oral assent (if required according to local requirements)
- Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than or equal to 11.0 years at the time of signing informed consent.
- Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than or equal to 10.0 years at the time of signing informed consent. Tanner stage 1 for breast development (no palpable glandular breast tissue)
- Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the WHO International Somatropin 98/574 standard
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- If only one growth hormone stimulation test is available before screening, then confirmation of growth hormone deficiency by second and different growth hormone stimulation test must be done
- For children with at least 2 additional pituitary hormone deficiencies (other than growth hormone deficiency) only one growth hormone stimulation test is needed
- Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender according to Chinese general population standards at screening
- Impaired height velocity defined as annualised height velocity at screening less than 7cm/year for subjects between 2.5 and 3 years old and less than 5 cm/year for subjects from 3 years and above calculated over a time span of minimum 3 months and maximum 18 months prior to screening according to Chinese guideline and expert consensus on children with short stature and GH therapy
- No prior exposure to growth hormone therapy or IGF-I treatment
- Bone age less than chronological age at screening
- Body Mass Index more than 5th and less than 95th percentile, Body Mass Index-for-age growth charts according to Chinese general population standards.
- IGF-I < -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
- No intracranial tumour confirmed by magnetic resonance imaging or computer tomography scan. An image or scan taken within 9 months prior to screening can be used as screening data if the medical evaluation and conclusion is available
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products.
- Previous participation in this trial. Participation is defined as randomisation.
- Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical trial before randomisation
- Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements:
- Turner Syndrome (including mosaicisms)
- Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Laron syndrome, Noonan syndrome, Prader-Willi Syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors
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- Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
- Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome or skeletal dysplasias
- Family history of skeletal dysplasia
- Children born small for gestational age (birth weight 10th percentile of the recommended gender-specific birth weight for gestational age according to national standards in China5
- Children diagnosed with diabetes mellitus or screening values from central laboratory of
- fasting plasma glucose more than or equal to 126 mg/dl (7.0 mmol/L) or
- HbA1c more than or equal to 6.5 %
- Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
- Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
- Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD)
- Diagnosis of attention deficit hyperactivity disorder
- Prior history or presence of malignancy including intracranial tumours
- Prior history or known presence of active Hepatitis B or Hepatitis C (exceptions to this exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B)
- Any clinically significant abnormal laboratory screening tests, as judged by the study doctor
- Any disorder which, in the opinion of the study doctor, might jeopardise Participant's safety or compliance with the protocol
- The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to trial conduct, as judged by the study doctor
- Children with hypothyroidism and/or adrenal insufficiency not on adequate and stable replacement therapy for at least 90 days prior to randomisation.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
Capital Center for Children's Health, Capital Medical University-Endocrinology
Beijing, Beijing Municipality, 100020
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
The First Bethune Hospital of Jilin University-Pediatric
Changchun, Jilin, 130021
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Julin
Hunan Children's Hospital-Child Health Center
Changsha, Hunan, 410007
Hunan Children's Hospital
Changsha, Hunan, 410007
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610000
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
The Third Affiliated Hospital, Sun Yat-Sen University-Pediatric
Guangzhou, Guangdong, 510630
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
The First Hospital of Jiaxing-Pediatric
Jiaxing, Jiangxi, 314001
The First Hospital of Jiaxing
Jiaxing, Jiangxi, 314001
Shandong Provincial Hospital-Pediatric
Jinan, Shandong, 250098
Women & Children's Health Care Hospital of Linyi-Endocrine Genetics and Metabolism
Linyi, Shandong, 276016
Jiangxi Provincial Children's Hospital-Endocrine Genetics and Metabolism
Nanchang, Jiangsu, 330006
Pingxiang Maternal and Child Health Care Hospital-Child Health Care
Pingxiang, Jiangxi, 337055
Pingxiang Maternal and Child Health Care Hospital
Pingxiang, Jiangxi, 337055
Qingdao Women and Children's Hospital-Pediatric Endocrinology&Metabolism
Qingdao, Shandong, 266034
Qingdao Women and Children's Hospital
Qingdao, Shandong, 266043
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, 200062
The First Affiliated Hospital of Shaoyang University-Pediatric
Shaoyang, Hunan, 422001
Children's Hospital of Soochow University-Endocrine Genetics and Metabolism
Suzhou, Jiangsu, 215025
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215025
Tongji Hospital, Tongji Medical College of HUST-Pediatric
Wuhan, Hubei, 430030
Wuhan Children Hospital-Endocrine Genetics and Metabolism
Wuhan
Wuxi Children's Hospital-Pediatric Endocrinology
Wuxi, Jiangsu, 214023
Wuxi Children's Hospital
Wuxi, Jiangsu, 214023
The First Affiliated Hospital of Xiamen University-Pediatric
Xiamen, Fujian, 361003
Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
Zhengzhou, Henan, 450018
Henan Children's Hospital
Zhengzhou, Henan, 450018
About this study
Official title: A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency
The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day. Researchers will test somapacitan to see how well it works, compared to the standard treatment with Norditropin®. The participants will either get Norditropin® once every day or somapacitan once every week - which treatment the participant gets is decided by chance. The participant and the study doctor will know which treatment the participant gets. The study includes a 52 week treatment period and a minimum of 30 days follow up period.
- Conditions
- Growth Hormone Deficiency in Children
- Being tested
- somapacitan, Norditropin®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somapacitanDrug
Somapacitan (0.16 mg/kg/week) will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
Norditropin®Drug
Norditropin® (0.034 mg/kg/day) will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.
| Study group | Role | What they receive |
|---|---|---|
| Somapacitan weekly | Experimental | participants will receive once-weekly somapacitan for 52 weeks Receives: Drug: somapacitan |
| Norditropin® daily | Active comparator | Participants will receive Norditropin® daily for 52 weeks Receives: Drug: Norditropin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height Velocity
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).
Measured: Baseline (Week 0); Week 52
Secondary outcomes (7)
Change in Bone Age
Change in bone age is presented from week -2 to week 52. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Measured: Week -2, week 52
Change in Height Standard Deviation Score
Change in the height standard deviation score (HSDS) is presented from baseline (week 0) to week 52. HSDS was derived using Chinese general population standards. The formula to calculate HSDS is: HSDS = ((Height / M)**L-1) / (L*S). L: The sex and age-specific power in the Box-Cox transformation, M: The sex and age-specific median, S: The sex and age-specific generalized coefficient of variation. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Measured: Baseline (week 0), week 52
Change in Height Velocity Standard Deviation Score
Change in height velocity standard deviation score (HVSDS) is presented from baseline (week 0) to week 52. HVSDS was derived using Prader standards. HVSDS was calculated using the formula: HVSDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Measured: Baseline (week 0), week 52
Change in Fasting Plasma Glucose
Change in fasting plasma glucose is presented from baseline (week 0) to week 52. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Measured: Baseline (week 0), week 52
Change in HbA1c
Change in glycosylated haemoglobin (HbA1c) is presented from baseline (week 0) to week 52 is presented. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Measured: Baseline (week 0), week 52
Change in IGF-I Standard Deviation Score
Change in Insulin like growth factor-I (IGF-I) standard deviation score is presented from baseline (week 0) to week 52. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Measured: Baseline (week 0), week 52
Change in IGFBP-3 Standard Deviation Score
Change in Insulin like growth factor binding protein 3 (IGFBP-3) standard deviation score is presented from baseline (week 0) to week 52. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Measured: Baseline (week 0), week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start22 Jul 2021
- Primary completion17 Nov 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Growth Hormone Deficiency in ChildrenStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970654
- Sponsor's protocol ID
- NN8640-4468
- Other IDs
- U1111-1250-7530, 2020-002974-28
- Status last verified
- Dec 2025
- First submitted
- 12 Jul 2021
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT04970654
- Acronym / sponsor ID
- NN8640-4468
- Conditions
- Growth Hormone Deficiency in Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day. Researchers will test somapacitan to see how well it works, compared to the standard treatment with Norditropin®. The participants will either get Norditropin® once every day or somapacitan once every week - which treatment the participant gets is decided by chance. The participant and the study doctor will know which treatment the participant gets. The study includes a 52 week treatment period and a minimum of 30 days follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somapacitan weekly | Experimental | Drug: somapacitanparticipants will receive once-weekly somapacitan for 52 weeks |
| Norditropin® daily | Active comparator | Drug: Norditropin®Participants will receive Norditropin® daily for 52 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Informed consent of parent or legally acceptable representative of participant and child assent, as age-appropriate must be obtained before any trial related activities
- The parent or legally acceptable representative of the child must sign and date the Informed consent form (according to local requirements)
- The child must sign and date child assent form or provide oral assent (if required according to local requirements)
- Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than or equal to 11.0 years at the time of signing informed consent.
- Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than or equal to 10.0 years at the time of signing informed consent. Tanner stage 1 for breast development (no palpable glandular breast tissue)
Key exclusion criteria (23 listed)
- Known or suspected hypersensitivity to trial product(s) or related products.
- Previous participation in this trial. Participation is defined as randomisation.
- Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical trial before randomisation
- Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements:
- Turner Syndrome (including mosaicisms)
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 |
|---|---|---|
| somapacitanSomapacitan (0.16 mg/kg/week) will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight. | Drug | Somapacitan weekly |
| Norditropin®Norditropin® (0.034 mg/kg/day) will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight. | Drug | Norditropin® daily |
Primary outcome
Height Velocity
Time frame: Baseline (Week 0); Week 52
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).
7 secondary outcomes
Change in Bone Age
Time frame: Week -2, week 52
Change in Height Standard Deviation Score
Time frame: Baseline (week 0), week 52
Change in Height Velocity Standard Deviation Score
Time frame: Baseline (week 0), week 52
Change in Fasting Plasma Glucose
Time frame: Baseline (week 0), week 52
Change in HbA1c
Time frame: Baseline (week 0), week 52
Change in IGF-I Standard Deviation Score
Time frame: Baseline (week 0), week 52
Change in IGFBP-3 Standard Deviation Score
Time frame: Baseline (week 0), week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency (dept. 1452) study director
Novo Nordisk A/S
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing somapacitan and Norditropin® in people with Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 32 sites in China.
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 15 inclusion and 23 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China. 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 10 Dec 2024). 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?
Height Velocity (time frame: Baseline (Week 0); Week 52). 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 Jan 2026.