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NCT03878446 · ClinicalTrials.gov registry record · Phase 2
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
A Phase 2 study of Short Stature Children Born Small for Gestational Age (SGA), sponsored by Novo Nordisk A/S.
- Active
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 20
- Study locations
NCT03878446: Active Phase 2 study of Short Stature Children Born Small for Gestational Age (SGA), sponsored by Novo Nordisk A/S.
NCT03878446 is a Phase 2 study of Short Stature Children Born Small for Gestational Age (SGA) that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878446, a Phase 2 study of Short Stature Children Born Small for Gestational Age (SGA), is active but no longer recruiting, sponsored by Novo Nordisk A/S.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and week 26 visit as: HV = (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years). The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first.
Conditions Studied
Interventions
- DRUG Somapacitan
- DRUG Norditropin®
Study Locations (20)
Other
- CHU Bab El Oued Pediatrics Dept - Algiers
- Endo and Diab Dept El Oued - Algiers
- endocrino-diabetology department, Hospital IBN BADIS. - Constantine
- Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie - Graz
- LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde - Salzburg
New York
- NYU Langone Hospital-LI - Garden City
- NYU Langone Hospital-LI - Mineola
- Icahn Sch of Med-Mt Sinai Hosp - New York
Minnesota
- Univ of Minnesota M.C.H. - Minneapolis
- Children's Minnesota - Saint Paul
New Jersey
- Goryeb Children's Hospital - Morristown
- Rutgers-Rwjms - New Brunswick
Alabama
- Univ of AL at Birmingham_BRM - Birmingham
California
- Children's Hosp Of Orange - Orange
Idaho
- St. Luke's Children's Endo - Boise
Ohio
- CCHMC_Cinc - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-07-04 |
| Est. Completion | 2026-12-23 |
| Phase | Phase 2 |
What the registry record for NCT03878446 still lists
NCT03878446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Short Stature Children Born Small for Gestational Age (SGA) appearing as the primary indexed condition, and to 2 interventions - of which Somapacitan is the first listed.
NCT03878446 names 20 study sites across 12 states, led by Other, New York, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03878446 about?
NCT03878446 is a clinical study titled "A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day". 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 ...
What is the current status of trial NCT03878446?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2019-07-04. Estimated completion is 2026-12-23.
What conditions does trial NCT03878446 study?
This clinical trial studies the following conditions: Short Stature Children Born Small for Gestational Age (SGA).
What interventions are being tested in trial NCT03878446?
The interventions under investigation include: Somapacitan (DRUG), Norditropin® (DRUG).
Who is sponsoring clinical trial NCT03878446?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03878446 being conducted?
This trial has 20 study locations across Alabama, California, Idaho, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03878446's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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