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CompletedNCT03811535REAL4Updated Oct 22, 2026Results posted

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

A Phase 3 interventional study of Somapacitan and Norditropin® in Growth Hormone Deficiency in Children, sponsored by Novo Nordisk A/S. Completed at 139 sites in 26 countries. Open to participants aged Up to 11 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Updated Oct 22, 2026Study documents postedPosted results revised+2 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
Up to 11 Years
Sex
All
01

Study summary

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

02

Conditions studied

  • Growth Hormone Deficiency in Children
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.

Browse Novo Nordisk A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. 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 World Health Organisation (WHO) International Somatropin 98/574 standard
  • Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
  • Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
  • Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
  • No prior exposure to growth hormone therapy or IGF-I treatment

Exclusion criteria

Exclusion Criteria:

  • Any known or suspected abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
  • Current inflammatory diseases requiring systemic treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
  • Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
  • Diagnosis of attention deficit hyperactivity disorder
  • 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
  • Prior history or presence of including intracranial tumours
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Somapacitan weekly

    Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).

    Drug: Somapacitan

  • Active comparator
    Norditropin® daily

    Participants will receive Norditropin® daily for 52 weeks (main trial period).

    Drug: Norditropin®

Interventions

  • DrugSomapacitan

    Somapacitan 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.

  • DrugNorditropin®

    Norditropin® 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.

06

What researchers measure

Primary outcomes

  1. Height Velocity: In-trial Observation Period

    Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: From baseline (week 0) to visit 7 (week 52)

  2. Height Velocity: On-treatment Observation Period

    Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.

    Time frame: From baseline (week 0) to visit 7 (week 52)

Secondary outcomes

  1. Change in Bone Age

    Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week -2), week 52

  2. Change in Height Standard Deviation Score (HSDS)

    Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. 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. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 52

  3. Change in Height Velocity Standard Deviation Score (HV SDS)

    Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (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 HV SDS 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. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 52

  4. Change in Fasting Plasma Glucose (FPG) at Week 52

    Change from baseline (week -2) in FPG at week 52 is presented.

    Time frame: Baseline (week -2), week 52

  5. Change in FPG at Week 104

    Change from baseline (week -2) in FPG at week 104 is presented.

    Time frame: Baseline (week -2), week 104

  6. Change in FPG at Week 156

    Change from baseline (week -2) in FPG at week 156 is presented.

    Time frame: Baseline (week -2), week 156

  7. Change in FPG at Week 208

    Change from baseline (week -2) in FPG at week 208 is presented.

    Time frame: Baseline (week -2), week 208

  8. Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52

    Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin (picomoles per liter \[pmol/L\]) \* 1/6(microunit per milliliter \[µU/mL\]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

    Time frame: Baseline (week -2), week 52

  9. Change in HOMA-B at Week 104

    Change from baseline (week -2) in HOMA-B at week 104 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin \[pmol/L\]) \* 1/6 (\[µU/mL\] / FPG (mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

    Time frame: Baseline (week -2), week 104

  10. Change in HOMA-B at Week 156

    Change from baseline (week -2) in HOMA-B at week 156 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin \[pmol/L\]) \* 1/6 (\[µU/mL\] / FPG (mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

    Time frame: Baseline (week -2), week 156

  11. Change in HOMA-B at Week 208

    Change from baseline (week -2) in HOMA-B at week 208 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin \[pmol/L\]) \* 1/6 (\[µU/mL\] / FPG (mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

    Time frame: Baseline (week -2), week 208

  12. Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52

    Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

    Time frame: Baseline (week -2), week 52

  13. Change in HOMA-IR at Week 104

    Change from baseline (week -2) in HOMA-IR at week 104 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG (mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

    Time frame: Baseline (week -2), week 104

  14. Change in HOMA-IR at Week 156

    Change from baseline (week -2) in HOMA-IR at week 156 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG (mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

    Time frame: Baseline (week -2), week 156

  15. Change in HOMA-IR at Week 208

    Change from baseline (week -2) in HOMA-IR at week 208 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG (mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

    Time frame: Baseline (week -2), week 208

  16. Change in Glycated Haemoglobin (HbA1c) at Week 52

    Change from baseline (week -2) in HbA1c at week 52 is presented.

    Time frame: Baseline (week -2), week 52

  17. Change in HbA1c at Week 104

    Change from baseline (week -2) in HbA1c at week 104 is presented.

    Time frame: Baseline (week -2), week 104

  18. Change in HbA1c at Week 156

    Change from baseline (week -2) in HbA1c at week 156 is presented.

    Time frame: Baseline (week -2), week 156

  19. Change in HbA1c at Week 208

    Change from baseline (week -2) in HbA1c at week 208 is presented.

    Time frame: Baseline (week -2), week 208

  20. Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52

    Change from baseline (week 0) in IGF-I SDS at week 52 is presented. 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. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 52

  21. Change in IGF-I SDS at Week 104

    Change from baseline (week 0) in IGF-I SDS at week 104 is presented. 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. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 104

  22. Change in IGF-I SDS at Week 156

    Change from baseline (week 0) in IGF-I SDS at week 156 is presented. 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. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 156

  23. Change in IGF-I SDS at Week 208

    Change from baseline (week 0) in IGF-I SDS at week 208 is presented. 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. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 208

  24. Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52

    Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. 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. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 52

  25. Change in IGFBP-3 SDS at Week 104

    Change from baseline (week 0) in IGFBP-3 SDS at week 104 is presented. 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. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 104

  26. Change in IGFBP-3 SDS at Week 156

    Change from baseline (week 0) in IGFBP-3 SDS at week 156 is presented. 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. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 156

  27. Change in IGFBP-3 SDS at Week 208

    Change from baseline (week 0) in IGFBP-3 SDS at week 208 is presented. 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. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

    Time frame: Baseline (week 0), week 208

07

Results

Posted Aug 4, 2023

Participant flow

The trial was conducted at 85 sites in 20 countries as follows: Austria; Canada; Denmark; France; Germany; Hungary; India; Israel; Italy; Japan; Korea; Latvia; Poland; Russia; Serbia; Slovenia; Spain; Switzerland; Thailand; Ukraine; United Kingdom; United States.

Main Period (52 Weeks)
Participant flow — Main Period (52 Weeks)
MilestoneNorditropin/ SomapacitanSomapacitan/ Somapacitan
Started68132
Completed68131
Not completed01
Withdrew: Withdrawal by parent/ guardian01
Safety Extension Period (Week 52 to 208)
Participant flow — Safety Extension Period (Week 52 to 208)
MilestoneNorditropin/ SomapacitanSomapacitan/ Somapacitan
Started68131
Completed62120
Not completed611
Withdrew: Lost to follow-up04
Withdrew: Physician decision10
Withdrew: Withdrawal by subject01
Withdrew: Withdrawal by parent/ guardian33
Withdrew: Other23
Additional Extensionperiod(afterweek208)
Participant flow — Additional Extensionperiod(afterweek208)
MilestoneNorditropin/ SomapacitanSomapacitan/ Somapacitan
Started3568
Completed00
Not completed3568
Withdrew: Physician decision01
Withdrew: Withdrawal by parent/ guardian01
Withdrew: Somapacitan was available for prescription3566

Outcome measures

PrimaryHeight Velocity: In-trial Observation Period

Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
From baseline (week 0) to visit 7 (week 52)
Reported as:
Mean · centimeters per year (cm/year)
Height Velocity: In-trial Observation Period
centimeters per year (cm/year)NorditropinSomapacitan
Height Velocity: In-trial Observation Period11.8 ± 2.911.2 ± 2.5
Statistical analysis
  • Norditropin vs Somapacitan · ANCOVA · Treatment difference: -0.5 · 95% CI -1.1 to 0.2
PrimaryHeight Velocity: On-treatment Observation Period

Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.

Time frame:
From baseline (week 0) to visit 7 (week 52)
Reported as:
Mean · cm/year
Height Velocity: On-treatment Observation Period
cm/yearNorditropinSomapacitan
Height Velocity: On-treatment Observation Period11.8 ± 2.911.2 ± 2.5
Statistical analysis
  • Norditropin vs Somapacitan · Mixed Models Analysis · Treatment difference: -0.5 · 95% CI -1.1 to 0.2
SecondaryChange in Bone Age

Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week -2), week 52
Reported as:
Mean · Years
Change in Bone Age
YearsNorditropinSomapacitan
Change in Bone Age1.28 ± 0.761.13 ± 0.78
SecondaryChange in Height Standard Deviation Score (HSDS)

Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. 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. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 52
Reported as:
Mean · Score on a scale
Change in Height Standard Deviation Score (HSDS)
Score on a scaleNorditropinSomapacitan
Change in Height Standard Deviation Score (HSDS)1.37 ± 0.691.21 ± 0.54
SecondaryChange in Height Velocity Standard Deviation Score (HV SDS)

Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (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 HV SDS 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. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 52
Reported as:
Mean · Score on a scale
Change in Height Velocity Standard Deviation Score (HV SDS)
Score on a scaleNorditropinSomapacitan
Change in Height Velocity Standard Deviation Score (HV SDS)8.97 ± 4.387.97 ± 3.36
SecondaryChange in Fasting Plasma Glucose (FPG) at Week 52

Change from baseline (week -2) in FPG at week 52 is presented.

Time frame:
Baseline (week -2), week 52
Reported as:
Mean · Millimoles per liter (mmol/L)
Change in Fasting Plasma Glucose (FPG) at Week 52
Millimoles per liter (mmol/L)NorditropinSomapacitan
Change in Fasting Plasma Glucose (FPG) at Week 520.255 ± 0.80.083 ± 0.6
SecondaryChange in FPG at Week 104

Change from baseline (week -2) in FPG at week 104 is presented.

Time frame:
Baseline (week -2), week 104
Reported as:
Mean · mmol/L
Change in FPG at Week 104
mmol/LNorditropinSomapacitan
Change in FPG at Week 1040.108 ± 0.90.068 ± 0.5
SecondaryChange in FPG at Week 156

Change from baseline (week -2) in FPG at week 156 is presented.

Time frame:
Baseline (week -2), week 156
Reported as:
Mean · mmol/L
Change in FPG at Week 156
mmol/LNorditropinSomapacitan
Change in FPG at Week 1560.033 ± 0.80.111 ± 0.6
SecondaryChange in FPG at Week 208

Change from baseline (week -2) in FPG at week 208 is presented.

Time frame:
Baseline (week -2), week 208
Reported as:
Mean · mmol/L
Change in FPG at Week 208
mmol/LNorditropinSomapacitan
Change in FPG at Week 2080.249 ± 0.80.225 ± 0.6
SecondaryChange in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52

Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin (picomoles per liter \[pmol/L\]) \* 1/6(microunit per milliliter \[µU/mL\]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

Time frame:
Baseline (week -2), week 52
Reported as:
Mean · Percentage of HOMA-B
Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52
Percentage of HOMA-BNorditropinSomapacitan
Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 5269.24 ± 81.5937.71 ± 59.25
SecondaryChange in HOMA-B at Week 104

Change from baseline (week -2) in HOMA-B at week 104 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin \[pmol/L\]) \* 1/6 (\[µU/mL\] / FPG (mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

Time frame:
Baseline (week -2), week 104
Reported as:
Mean · Percentage of HOMA-B
Change in HOMA-B at Week 104
Percentage of HOMA-BNorditropinSomapacitan
Change in HOMA-B at Week 10460.86 ± 59.2247.43 ± 88.48
SecondaryChange in HOMA-B at Week 156

Change from baseline (week -2) in HOMA-B at week 156 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin \[pmol/L\]) \* 1/6 (\[µU/mL\] / FPG (mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

Time frame:
Baseline (week -2), week 156
Reported as:
Mean · Percentage of HOMA-B
Change in HOMA-B at Week 156
Percentage of HOMA-BNorditropinSomapacitan
Change in HOMA-B at Week 15664.74 ± 93.0245.51 ± 68.60
SecondaryChange in HOMA-B at Week 208

Change from baseline (week -2) in HOMA-B at week 208 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin \[pmol/L\]) \* 1/6 (\[µU/mL\] / FPG (mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

Time frame:
Baseline (week -2), week 208
Reported as:
Mean · Percentage of HOMA-B
Change in HOMA-B at Week 208
Percentage of HOMA-BNorditropinSomapacitan
Change in HOMA-B at Week 208110.22 ± 212.9646.41 ± 65.14
SecondaryChange in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52

Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

Time frame:
Baseline (week -2), week 52
Reported as:
Mean · Percentage of HOMA-IR
Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52
Percentage of HOMA-IRNorditropinSomapacitan
Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 521.03 ± 1.120.60 ± 1.13
SecondaryChange in HOMA-IR at Week 104

Change from baseline (week -2) in HOMA-IR at week 104 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG (mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

Time frame:
Baseline (week -2), week 104
Reported as:
Mean · Percentage of HOMA-IR
Change in HOMA-IR at Week 104
Percentage of HOMA-IRNorditropinSomapacitan
Change in HOMA-IR at Week 1040.85 ± 1.010.51 ± 0.96
SecondaryChange in HOMA-IR at Week 156

Change from baseline (week -2) in HOMA-IR at week 156 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG (mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

Time frame:
Baseline (week -2), week 156
Reported as:
Mean · Percentage of HOMA-IR
Change in HOMA-IR at Week 156
Percentage of HOMA-IRNorditropinSomapacitan
Change in HOMA-IR at Week 1560.61 ± 0.800.63 ± 1.06
SecondaryChange in HOMA-IR at Week 208

Change from baseline (week -2) in HOMA-IR at week 208 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG (mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

Time frame:
Baseline (week -2), week 208
Reported as:
Mean · Percentage of HOMA-IR
Change in HOMA-IR at Week 208
Percentage of HOMA-IRNorditropinSomapacitan
Change in HOMA-IR at Week 2081.24 ± 1.530.91 ± 1.72
SecondaryChange in Glycated Haemoglobin (HbA1c) at Week 52

Change from baseline (week -2) in HbA1c at week 52 is presented.

Time frame:
Baseline (week -2), week 52
Reported as:
Mean · Percentage of HbA1c
Change in Glycated Haemoglobin (HbA1c) at Week 52
Percentage of HbA1cNorditropinSomapacitan
Change in Glycated Haemoglobin (HbA1c) at Week 520.11 ± 0.260.09 ± 0.22
SecondaryChange in HbA1c at Week 104

Change from baseline (week -2) in HbA1c at week 104 is presented.

Time frame:
Baseline (week -2), week 104
Reported as:
Mean · Percentage of HbA1c
Change in HbA1c at Week 104
Percentage of HbA1cNorditropinSomapacitan
Change in HbA1c at Week 1040.19 ± 0.250.11 ± 0.22
SecondaryChange in HbA1c at Week 156

Change from baseline (week -2) in HbA1c at week 156 is presented.

Time frame:
Baseline (week -2), week 156
Reported as:
Mean · Percentage of HbA1c
Change in HbA1c at Week 156
Percentage of HbA1cNorditropinSomapacitan
Change in HbA1c at Week 1560.14 ± 0.260.12 ± 0.21
SecondaryChange in HbA1c at Week 208

Change from baseline (week -2) in HbA1c at week 208 is presented.

Time frame:
Baseline (week -2), week 208
Reported as:
Mean · Percentage of HbA1c
Change in HbA1c at Week 208
Percentage of HbA1cNorditropinSomapacitan
Change in HbA1c at Week 2080.11 ± 0.240.08 ± 0.23
SecondaryChange in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52

Change from baseline (week 0) in IGF-I SDS at week 52 is presented. 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. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 52
Reported as:
Mean · Score on a scale
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52
Score on a scaleNorditropinSomapacitan
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 522.41 ± 1.092.32 ± 1.27
SecondaryChange in IGF-I SDS at Week 104

Change from baseline (week 0) in IGF-I SDS at week 104 is presented. 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. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 104
Reported as:
Mean · Score on a scale
Change in IGF-I SDS at Week 104
Score on a scaleNorditropinSomapacitan
Change in IGF-I SDS at Week 1042.05 ± 1.331.78 ± 0.98
SecondaryChange in IGF-I SDS at Week 156

Change from baseline (week 0) in IGF-I SDS at week 156 is presented. 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. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 156
Reported as:
Mean · Score on a scale
Change in IGF-I SDS at Week 156
Score on a scaleNorditropinSomapacitan
Change in IGF-I SDS at Week 1561.96 ± 1.021.79 ± 1.12
SecondaryChange in IGF-I SDS at Week 208

Change from baseline (week 0) in IGF-I SDS at week 208 is presented. 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. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 208
Reported as:
Mean · Score on a scale
Change in IGF-I SDS at Week 208
Score on a scaleNorditropinSomapacitan
Change in IGF-I SDS at Week 2082.19 ± 1.251.77 ± 1.12
SecondaryChange in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52

Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. 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. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 52
Reported as:
Mean · Score on a scale
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52
Score on a scaleNorditropinSomapacitan
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 521.68 ± 1.021.58 ± 0.92
SecondaryChange in IGFBP-3 SDS at Week 104

Change from baseline (week 0) in IGFBP-3 SDS at week 104 is presented. 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. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 104
Reported as:
Mean · Score on a scale
Change in IGFBP-3 SDS at Week 104
Score on a scaleNorditropinSomapacitan
Change in IGFBP-3 SDS at Week 1041.49 ± 0.951.43 ± 0.84
SecondaryChange in IGFBP-3 SDS at Week 156

Change from baseline (week 0) in IGFBP-3 SDS at week 156 is presented. 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. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 156
Reported as:
Mean · Score on a scale
Change in IGFBP-3 SDS at Week 156
Score on a scaleNorditropinSomapacitan
Change in IGFBP-3 SDS at Week 1561.53 ± 0.861.56 ± 0.96
SecondaryChange in IGFBP-3 SDS at Week 208

Change from baseline (week 0) in IGFBP-3 SDS at week 208 is presented. 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. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Time frame:
Baseline (week 0), week 208
Reported as:
Mean · Score on a scale
Change in IGFBP-3 SDS at Week 208
Score on a scaleNorditropinSomapacitan
Change in IGFBP-3 SDS at Week 2081.69 ± 0.881.51 ± 0.87

Adverse events

Collected over Week -2 to week 312. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Somapacitan Week 0-520/132 (0%)7/132 (5.3%)63/132 (47.7%)
Norditropin Week 0-520/68 (0%)2/68 (2.9%)32/68 (47.1%)
Somapacitan/Somapacitan Week 52-2080/131 (0%)11/131 (8.4%)92/131 (70.2%)
Norditropin/Somapacitan Week 52-2080/68 (0%)4/68 (5.9%)46/68 (67.6%)
Norditropin/Somapacitan Week > 2080/35 (0%)1/35 (2.9%)14/35 (40%)
Somapacitan/Somapacitan Week > 2080/68 (0%)4/68 (5.9%)27/68 (39.7%)
Most frequent serious events
Showing 10 of 33
Most frequent serious events
EventSomapacitan Week 0-52Norditropin Week 0-52Somapacitan/Somapacitan Week 52-208Norditropin/Somapacitan Week 52-208Norditropin/Somapacitan Week > 208Somapacitan/Somapacitan Week > 208
Tonsillar hypertrophyRespiratory, thoracic and mediastinal disorders0/1320/680/1310/681/350/68
GastroenteritisInfections and infestations0/1321/682/1310/680/350/68
Adenoidal hypertrophyRespiratory, thoracic and mediastinal disorders2/1320/681/1311/680/350/68
Adrenocortical insufficiency acuteEndocrine disorders0/1321/680/1310/680/350/68
Blood creatine phosphokinase increasedInvestigations0/1320/680/1311/680/350/68
COVID-19Infections and infestations0/1321/681/1310/680/350/68
Chromosomal microduplicationCongenital, familial and genetic disorders0/1320/680/1311/680/350/68
ConcussionInjury, poisoning and procedural complications0/1320/681/1311/680/350/68
SynovitisMusculoskeletal and connective tissue disorders0/1320/680/1311/680/350/68
Umbilical herniaGastrointestinal disorders1/1320/680/1310/680/351/68
Most frequent other events
Showing 10 of 24
Most frequent other events
EventSomapacitan Week 0-52Norditropin Week 0-52Somapacitan/Somapacitan Week 52-208Norditropin/Somapacitan Week 52-208Norditropin/Somapacitan Week > 208Somapacitan/Somapacitan Week > 208
COVID-19Infections and infestations3/1322/6831/13118/680/350/68
NasopharyngitisInfections and infestations15/1327/6825/13111/682/355/68
PyrexiaGeneral disorders10/1328/6817/13111/686/353/68
HeadacheNervous system disorders17/1327/689/1314/680/352/68
InfluenzaInfections and infestations3/1322/6816/1314/681/352/68
Viral infectionInfections and infestations2/1321/687/1318/682/353/68
VomitingGastrointestinal disorders6/1324/6814/1315/681/353/68
BronchitisInfections and infestations4/1325/689/1317/681/352/68
Upper respiratory tract infectionInfections and infestations3/1321/688/1317/680/353/68
Pain in extremityMusculoskeletal and connective tissue disorders12/1322/687/1311/682/350/68

Baseline characteristics

Full analysis set included all randomized participants.

Age, Continuous
Age, Continuous(years)Norditropin/ SomapacitanSomapacitan/ SomapacitanTotal
Mean6.43 ± 2.426.38 ± 2.236.40 ± 2.29
Sex: Female, Male
Sex: Female, Male(Participants)Norditropin/ SomapacitanSomapacitan/ SomapacitanTotal
Female183351
Male5099149
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Norditropin/ SomapacitanSomapacitan/ SomapacitanTotal
Hispanic or Latino145
Not Hispanic or Latino63119182
Unknown or Not Reported4913
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Norditropin/ SomapacitanSomapacitan/ SomapacitanTotal
Race — White3678114
Race — Asian284674
Race — Black or African American101
Race — Other011
Race — Not reported3710
08

Study locations

139 sites
  • Univ of AL at Birmingham_BRM
    Birmingham, Alabama 35233, United States
  • Children's Hospital Los Angeles - Endocrinology
    Los Angeles, California 90027, United States
  • Valley Children's Hospital
    Madera, California 93636-8762, United States
  • Children's Hosp Of Orange
    Orange, California 92868, United States
  • Sutter Valley Med Fdt Ped Endo
    Sacramento, California 95821, United States
  • Rocky Mt Ped and Endo
    Centennial, Colorado 80112, United States
  • Ped Endo Assoc PC-G.V
    Greenwood Village, Colorado 80111-2803, United States
  • Yale-New Haven Hospital
    New Haven, Connecticut 06504, United States
  • A.I. duPont Hospital for Children/Nemours
    Wilmington, Delaware 19803, United States
  • Pediatric Endocrine & Wellness Center
    Aventura, Florida 33180, United States
  • Van Meter Pediatric Endo PC
    Atlanta, Georgia 30318, United States
  • Riley Hospital For Children
    Indianapolis, Indiana 46202, United States
  • University OF Iowa
    Iowa City, Iowa 52242, United States
  • Univ of Minnesota M.C.H.
    Minneapolis, Minnesota 55454, United States
  • Children's Minnesota
    Saint Paul, Minnesota 55102, United States
  • Children's Mercy Clinics
    Kansas City, Missouri 64111, United States
  • The Docs
    Las Vegas, Nevada 89113, United States
  • Goryeb Children's Hospital
    Morristown, New Jersey 07962, United States
  • UBMD Peds-Div of Endo/Diabetes
    Buffalo, New York 14203, United States
  • NYU Langone Hospital-LI
    Mineola, New York 11501, United States
  • WakeMed Childn Endo-Dbt_Raleig
    Raleigh, North Carolina 27610, United States
  • CCHMC_Cinc
    Cincinnati, Ohio 45229, United States
  • Univ Oklahoma Sci Ctr OK City
    Oklahoma City, Oklahoma 73104, United States
  • UPMC Child Hosp-Pittsburgh
    Pittsburgh, Pennsylvania 15224, United States
  • Dell Children's Medical Center
    Austin, Texas 78723, United States
  • Cook Children's Medical Center
    Fort Worth, Texas 76104, United States
  • MultiCare Inst for Res & Innov
    Tacoma, Washington 98405, United States
  • CHU Bab El Oued Pediatrics Dept
    Algiers, 16000, Algeria
  • Endo and Diab Dept El Oued
    Algiers, 16000, Algeria
  • endocrino-diabetology department, Hospital IBN BADIS.
    Constantine, 25000, Algeria
  • Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie
    Graz, 8036, Austria
  • LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde
    Salzburg, A 5020, Austria
  • LKH St. Poelten, Kinder-und Jugendheilkunde
    Sankt Pölten, 3100, Austria
  • Salzkammergut-Klinikum Vöcklabruck
    Vöcklabruck, 4840, Austria
  • Stollery Children's Hospital
    Edmonton, Alberta T6G 2B7, Canada
  • Mntrl Chldrn Hsptl PedEndoMUHC
    Montreal, Quebec H4A 3J1, Canada
  • Rigshospitalet Klinik for Vækst og Reproduktion Afsnit 5064
    Copenhagen Ø, 2100, Denmark
  • Tallinn Children's Hospital
    Tallinn, 13419, Estonia
  • Tartu University Hospital Children's Clinic
    Tartu, 50406, Estonia
  • Centre Hospitalier Universitaire D'Angers-2
    Angers, 49100, France
  • Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
    Bordeaux, 33000, France
  • Ap-Hp-Hopital de Bicetre
    Le Kremlin-Bicêtre, 94270, France
  • Hopital de Bicetre_Le Kremlin-Bicetre
    Le Kremlin-Bicêtre, 94275, France
  • Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2
    Marseille, 13005, France
  • Hopital de La Timone
    Marseille Cédex 05, 13385, France
  • Ap-Hp-Hopital Necker
    Paris, 75015, France
  • HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie
    Toulouse, 31059, France
  • Endokrinologikum Frankfurt
    Frankfurt am Main, 60596, Germany
  • Auf der Bult Medizinisches Versorgungszentrum Hannover
    Hanover, 30159, Germany
  • Uniklinik Tübingen - Kinder- und Jugendmedizin
    Tübingen, 72076, Germany
  • Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
    Ulm, 89075, Germany
  • Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
    Budapest, 1023, Hungary
  • Szegedi Tudományegyetem Gyermekgyógyászati Klinika
    Szeged, 6720, Hungary
  • Amrita Institute Of Medical Sciences & Research Centre
    Kochi, Kerala 682041, India
  • Jehangir Clinical Development Centre
    Pune, Maharashtra 411001, India
  • All India Institute of Medical Sciences
    New Dehli, New Delhi 110029, India
  • CHI Crumlin Dept of Endocrinology
    Dublin, D12 N512, Ireland
  • Rambam MC - Department of Pediatrics A
    Haifa, 31096, Israel
  • Meir MC - Department of Paediatrics
    Kfar Saba, 44281, Israel
  • Schneider MC - Endrocrinology and Diabetes
    Petah Tikva, 49202, Israel
  • Shamir MC - Pediatric and Adolescents Endocrinology unit
    Tsrifin, 7033001, Israel
  • IRCCS Meyer Firenze
    Florence, 50139, Italy
  • Ospedale Pediatrico Gaslini
    Genova, 16147, Italy
  • Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
    Milan, 20122, Italy
  • Ospedale Pediatrico Bambino Gesu
    Roma, 00165, Italy
  • Kurume University Hospital, Pediatrics
    Fukuoka, 830-0011, Japan
  • Fukuoka Children's Hospital_Endocrinology and Metabolism
    Fukuoka-shi, Fukuoka, 813-0017, Japan
  • National Hospital Organization FUKUYAMA MEDICAL CENTER_Pediatrics
    Fukuyama-shi, Hiroshima, 720-8520, Japan
  • National Hospital Organization FUKUYAMA MEDICAL CENTER
    Fukuyama-shi, Hiroshima, 720-8520, Japan
  • Fukuyama City Hospital_Department of Pediatrics
    Fukuyama-shi, Hiroshima, 721-8511, Japan
  • Kanagawa Children's Medical Center_Endo and Metabo
    Kanagawa, 232-8555, Japan
  • Hyogo Prefectual Kobe Children's Hospital_Metab & endo
    Kobe-shi, Hyogo, 650-0047, Japan
  • Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics
    Kyoto, 602-8566, Japan
  • Ibaraki Children's Hospital_General Pediatrics
    Mito, Ibaraki, 311-4145, Japan
  • Nara Prefecture General Medical Center_ Nara-shi, Nara
    Nara-shi, Nara, 630-8581, Japan
  • Nara Prefecture General Medical Center_Pediatric
    Nara-shi, Nara, 630-8581, Japan
  • Niigata University Medical & Dental Hospital_Pediatrics
    Niigata-shi, Niigata, 951 8520, Japan
  • Aichi Children's Health and Medical Center
    Obu-shi, Aichi, 474-8710, Japan
  • Okayama Medical Center_Cardiology
    Okayama-shi, Okayama, 701-1192, Japan
  • Osaka City General Hospital, Pediatric Endocrinology and Me
    Osaka, 534-0021, Japan
  • Osaka Women's and Children's Hospital
    Osaka, 594-1101, Japan
  • Saitama Children's Medical Center, Endocrinorogy&Metabolism
    Saitama-shi, Saitama, 330-8777, Japan
  • Hamamatsu University Hospital_Pediatrics
    Shizuoka, 431-3192, Japan
  • Osaka University Hospital_Pediatrics
    Suita-shi, Osaka, 565-0871, Japan
  • Institute of Science Tokyo Hospital_Pediatrics
    Tokyo, 113-8519, Japan
  • KOUJIYA Kodomo Clinic
    Tokyo, 144-0034, Japan
  • National Center for Child Health and Dev, Endo and Metabo
    Tokyo, 157 8535, Japan
  • National Center for Child Health and Development_Endo and Metabo
    Tokyo, 157 8535, Japan
  • Tanaka Growth Clinic
    Tokyo, 158-0097, Japan
  • Keio University Hospital_Pediatrics
    Tokyo, 160-8582, Japan
  • Tokyo Metropolitan Children's Medical Center_Endo and Metab
    Tokyo, 183-8561, Japan
  • Children's Clinical University Hospital
    Riga, 1004, Latvia
  • Haukeland Universitetssykehus, Barneklinikken
    Bergen, 5021, Norway
  • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
    Rzeszów, Podkarpackie Voivodeship 35-301, Poland
  • SPSK nr 1 im Prof. T Sokolowskiego
    Szczecin, 71-252, Poland
  • Instytut ''Pomnik - Centrum Zdrowia Dziecka''
    Warsaw, 04-730, Poland
  • Republic Children's Hospital of Ministry of Health of Udmurt
    Izhevsk, 426009, Russia
  • Setchenov First Moscow State Medical University
    Moscow, 119435, Russia
  • RMAPE
    Moscow, 125373, Russia
  • Children's clinical city hospital #1
    Novosibirsk, 630048, Russia

Showing the first 100 of 139 sites across 26 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Miller BS, Blair JC, Rasmussen MH, Frystyk J, Lemminger AK, Maniatis A, Mori J, Bottcher V, Kim HS, Polak M, Horikawa R. Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4. Eur J Endocrinol. 2025 Apr 30;192(5):651-661. doi: 10.1093/ejendo/lvaf096. PubMed 40400262 ↗
  • Mori J, Ohata Y, Fujisawa Y, Sato Y, Rohrich S, Rasmussen MH, Bang RB, Horikawa R. Effective growth hormone replacement with once-weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial. Clin Endocrinol (Oxf). 2024 Apr;100(4):389-398. doi: 10.1111/cen.15025. Epub 2024 Feb 18. PubMed 38368603 ↗
  • Garner T, Clayton P, Hojby M, Murray P, Stevens A. Gene Expression Signatures Predict First-Year Response to Somapacitan Treatment in Children With Growth Hormone Deficiency. J Clin Endocrinol Metab. 2024 Apr 19;109(5):1214-1221. doi: 10.1210/clinem/dgad717. PubMed 38066644 ↗
  • Miller BS, Blair JC, Rasmussen MH, Maniatis A, Mori J, Bottcher V, Kim HS, Bang RB, Polak M, Horikawa R. Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH. J Clin Endocrinol Metab. 2023 Nov 17;108(12):3090-3099. doi: 10.1210/clinem/dgad394. PubMed 37406251 ↗
  • Miller BS, Blair JC, Rasmussen MH, Maniatis A, Kildemoes RJ, Mori J, Polak M, Bang RB, Bottcher V, Stagi S, Horikawa R. Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3378-3388. doi: 10.1210/clinem/dgac513. PubMed 36062966 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · www.novonordisk-trials.com

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Nov 2021, 29 months.

Results were first posted in Aug 2023, 1 year 8 months after primary completion. A results delay was requested in Oct 2022.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2019
First posted
Jan 22, 2019
StartActual
May 20, 2019
Primary completionActual
Nov 10, 2021
CompletionActual
Sep 30, 2025
Results delay requested
Oct 31, 2022
Results first posted
Aug 4, 2023
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Posted results revised
revised Oct 22, 2026
Sites
10 sites added, 6 sites removed
Show 10 added (7 Japan, 2 France, 1 South Korea)
  • Ap-Hp-Hopital de Bicetre · Le Kremlin-Bicêtre, France
  • Ap-Hp-Hopital Necker · Paris, France
  • National Hospital Organization FUKUYAMA MEDICAL CENTER_Pediatrics · Fukuyama-shi, Hiroshima, Japan
  • Kanagawa Children's Medical Center_Endo and Metabo · Kanagawa, Japan
  • Hyogo Prefectual Kobe Children's Hospital_Metab & endo · Kobe-shi, Hyogo, Japan
  • Nara Prefecture General Medical Center_Pediatric · Nara-shi, Nara, Japan
  • Hamamatsu University Hospital_Pediatrics · Shizuoka, Japan
  • National Center for Child Health and Development_Endo and Metabo · Tokyo, Japan
  • Keio University Hospital_Pediatrics · Tokyo, Japan
  • Ajou University Hospital · Suwon, South Korea
Show 6 removed
  • Ap-Hp-Hopital de Bicetre-1 · Le Kremlin-Bicêtre, France
  • Ap-Hp-Hopital Necker-2 · Paris, France
  • Kanagawa Children's Medical Center, Dev. Endo and Metabo · Kanagawa, Japan
  • Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo · Kobe-shi, Hyogo, Japan
  • Hamamatsu Univ. School of Medicine Hospital, Pediatrics · Shizuoka, Japan
  • Keio University Hospital, Pediatrics · Tokyo, Japan
Oct 22, 2026
Documents
Oct 22, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 38066644 ↗
Oct 22, 2026
Secondary outcomes
18 description edited
What changed in the outcomes
  • DescriptionChange in FPG at Week 104: how it is measured was reworded
  • DescriptionChange in FPG at Week 156: how it is measured was reworded
  • DescriptionChange in FPG at Week 208: how it is measured was reworded
  • DescriptionChange in HOMA-B at Week 104: how it is measured was reworded
  • DescriptionChange in HOMA-B at Week 156: how it is measured was reworded
  • DescriptionChange in HOMA-B at Week 208: how it is measured was reworded
  • DescriptionChange in HOMA-IR at Week 104: how it is measured was reworded
  • DescriptionChange in HOMA-IR at Week 156: how it is measured was reworded
  • DescriptionChange in HOMA-IR at Week 208: how it is measured was reworded
  • DescriptionChange in HbA1c at Week 104: how it is measured was reworded
  • DescriptionChange in HbA1c at Week 156: how it is measured was reworded
  • DescriptionChange in HbA1c at Week 208: how it is measured was reworded
  • DescriptionChange in IGF-I SDS at Week 104: how it is measured was reworded
  • DescriptionChange in IGF-I SDS at Week 156: how it is measured was reworded
  • DescriptionChange in IGF-I SDS at Week 208: how it is measured was reworded
  • DescriptionChange in IGFBP-3 SDS at Week 104: how it is measured was reworded
  • DescriptionChange in IGFBP-3 SDS at Week 156: how it is measured was reworded
  • DescriptionChange in IGFBP-3 SDS at Week 208: how it is measured was reworded
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Posted results revised
    Documents Protocol and statistical analysis plan ↗ updated
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 38066644 ↗
    10 sites added, 6 sites removed
    Show 10 added (7 Japan, 2 France, 1 South Korea)
    • Ap-Hp-Hopital de Bicetre · Le Kremlin-Bicêtre, France
    • Ap-Hp-Hopital Necker · Paris, France
    • National Hospital Organization FUKUYAMA MEDICAL CENTER_Pediatrics · Fukuyama-shi, Hiroshima, Japan
    • Kanagawa Children's Medical Center_Endo and Metabo · Kanagawa, Japan
    • Hyogo Prefectual Kobe Children's Hospital_Metab & endo · Kobe-shi, Hyogo, Japan
    • Nara Prefecture General Medical Center_Pediatric · Nara-shi, Nara, Japan
    • Hamamatsu University Hospital_Pediatrics · Shizuoka, Japan
    • National Center for Child Health and Development_Endo and Metabo · Tokyo, Japan
    • Keio University Hospital_Pediatrics · Tokyo, Japan
    • Ajou University Hospital · Suwon, South Korea
    Show 6 removed
    • Ap-Hp-Hopital de Bicetre-1 · Le Kremlin-Bicêtre, France
    • Ap-Hp-Hopital Necker-2 · Paris, France
    • Kanagawa Children's Medical Center, Dev. Endo and Metabo · Kanagawa, Japan
    • Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo · Kobe-shi, Hyogo, Japan
    • Hamamatsu Univ. School of Medicine Hospital, Pediatrics · Shizuoka, Japan
    • Keio University Hospital, Pediatrics · Tokyo, Japan
    Secondary outcomes 18 description edited
    What changed in the outcomes
    • DescriptionChange in FPG at Week 104: how it is measured was reworded
    • DescriptionChange in FPG at Week 156: how it is measured was reworded
    • DescriptionChange in FPG at Week 208: how it is measured was reworded
    • DescriptionChange in HOMA-B at Week 104: how it is measured was reworded
    • DescriptionChange in HOMA-B at Week 156: how it is measured was reworded
    • DescriptionChange in HOMA-B at Week 208: how it is measured was reworded
    • DescriptionChange in HOMA-IR at Week 104: how it is measured was reworded
    • DescriptionChange in HOMA-IR at Week 156: how it is measured was reworded
    • DescriptionChange in HOMA-IR at Week 208: how it is measured was reworded
    • DescriptionChange in HbA1c at Week 104: how it is measured was reworded
    • DescriptionChange in HbA1c at Week 156: how it is measured was reworded
    • DescriptionChange in HbA1c at Week 208: how it is measured was reworded
    • DescriptionChange in IGF-I SDS at Week 104: how it is measured was reworded
    • DescriptionChange in IGF-I SDS at Week 156: how it is measured was reworded
    • DescriptionChange in IGF-I SDS at Week 208: how it is measured was reworded
    • DescriptionChange in IGFBP-3 SDS at Week 104: how it is measured was reworded
    • DescriptionChange in IGFBP-3 SDS at Week 156: how it is measured was reworded
    • DescriptionChange in IGFBP-3 SDS at Week 208: how it is measured was reworded
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03811535
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jan 22, 2019
Start date
May 20, 2019
Primary completion
Nov 10, 2021
Completion
Sep 30, 2025
Results posted
Aug 4, 2023
Last update
Oct 22, 2026

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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