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Active, not recruiting Phase 2 Interventional Results available

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

ClinicalTrials.gov ID: NCT03878446

Public ClinicalTrials.gov record NCT03878446. 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.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 5:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.

Study identification

NCT ID
NCT03878446
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novo Nordisk A/S
Industry
Enrollment
62 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years 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
Jul 4, 2019 (Actual)
Primary completion
May 5, 2021 (Actual)
Completion
Dec 23, 2026 (Estimated)
Last update posted
Oct 6, 2026

2019 – 2026

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
14
Facility City State ZIP Site status
Univ of AL at Birmingham_BRM Birmingham Alabama 35233 —
Children's Hosp Of Orange Orange California 92868 —
St. Luke's Children's Endo Boise Idaho 83712 —
Univ of Minnesota M.C.H. Minneapolis Minnesota 55454 —
Children's Minnesota Saint Paul Minnesota 55102 —
Goryeb Children's Hospital Morristown New Jersey 07962 —
Rutgers-Rwjms New Brunswick New Jersey 08901 —
NYU Langone Hospital-LI Garden City New York 11530 —
NYU Langone Hospital-LI Mineola New York 11501 —
Icahn Sch of Med-Mt Sinai Hosp New York New York 10029 —
CCHMC_Cinc Cincinnati Ohio 45229 —
Univ Oklahoma Sci Ctr OK City Oklahoma City Oklahoma 73104 —
Cook Children's Hospital-Hematology-Oncology 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 81 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03878446, 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 6, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03878446 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →