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)
Public ClinicalTrials.gov record NCT03811535. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03811535
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 20, 2019 (Actual)
- Primary completion
- Nov 10, 2021 (Actual)
- Completion
- Sep 30, 2025 (Actual)
- Last update posted
- Oct 22, 2026
2019 – 2025
United States locations
- U.S. sites
- 27
- U.S. states
- 20
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of AL at Birmingham_BRM | Birmingham | Alabama | 35233 | — |
| Children's Hospital Los Angeles - Endocrinology | Los Angeles | California | 90027 | — |
| Valley Children's Hospital | Madera | California | 93636-8762 | — |
| Children's Hosp Of Orange | Orange | California | 92868 | — |
| Sutter Valley Med Fdt Ped Endo | Sacramento | California | 95821 | — |
| Rocky Mt Ped and Endo | Centennial | Colorado | 80112 | — |
| Ped Endo Assoc PC-G.V | Greenwood Village | Colorado | 80111-2803 | — |
| Yale-New Haven Hospital | New Haven | Connecticut | 06504 | — |
| A.I. duPont Hospital for Children/Nemours | Wilmington | Delaware | 19803 | — |
| Pediatric Endocrine & Wellness Center | Aventura | Florida | 33180 | — |
| Van Meter Pediatric Endo PC | Atlanta | Georgia | 30318 | — |
| Riley Hospital For Children | Indianapolis | Indiana | 46202 | — |
| University OF Iowa | Iowa City | Iowa | 52242 | — |
| Univ of Minnesota M.C.H. | Minneapolis | Minnesota | 55454 | — |
| Children's Minnesota | Saint Paul | Minnesota | 55102 | — |
| Children's Mercy Clinics | Kansas City | Missouri | 64111 | — |
| The Docs | Las Vegas | Nevada | 89113 | — |
| Goryeb Children's Hospital | Morristown | New Jersey | 07962 | — |
| UBMD Peds-Div of Endo/Diabetes | Buffalo | New York | 14203 | — |
| NYU Langone Hospital-LI | Mineola | New York | 11501 | — |
| WakeMed Childn Endo-Dbt_Raleig | Raleigh | North Carolina | 27610 | — |
| CCHMC_Cinc | Cincinnati | Ohio | 45229 | — |
| Univ Oklahoma Sci Ctr OK City | Oklahoma City | Oklahoma | 73104 | — |
| UPMC Child Hosp-Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Dell Children's Medical Center | Austin | Texas | 78723 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| MultiCare Inst for Res & Innov | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 112 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03811535, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03811535 live on ClinicalTrials.gov.