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NCT05330325 · ClinicalTrials.gov registry record · Phase 3
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
A Phase 3 study of SGA, Turner Syndrome, Noonan Syndrome, ISS, sponsored by Novo Nordisk A/S.
- Active
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
- 20
- Study locations
NCT05330325: Active Phase 3 study of SGA, Turner Syndrome, Noonan Syndrome, ISS, sponsored by Novo Nordisk A/S.
NCT05330325 is a Phase 3 study of SGA, Turner Syndrome, Noonan Syndrome, ISS that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 412 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05330325, a Phase 3 study of SGA, Turner Syndrome, Noonan Syndrome, ISS, is active but no longer recruiting, sponsored by Novo Nordisk A/S.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.
Primary Outcome
Measured in centimeter per year (cm/year)
Conditions Studied
Interventions
- DRUG Somapacitan
- DRUG Norditropin®
Study Locations (20)
California
- Children's Hospital Los Angeles - Endocrinology - Los Angeles
- Sutter Valley Med Fdt Ped Endo - Sacramento
- Rady Childrens Hosp San Diego - San Diego
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mt Ped and Endo - Centennial
- Ped Endo Assoc PC-G.V - Greenwood Village
Idaho
- St. Luke's Children's Endo - Boise
- Rocky Mt Clin Res, LLC - Idaho Falls
Minnesota
- Univ of Minnesota M.C.H. - Minneapolis
- Children's Minnesota - Saint Paul
Alabama
- Univ of AL at Birmingham_BRM - Birmingham
Delaware
- Nemours/AI duPont Hosp-Chld - Wilmington
District of Columbia
- Childrens National Medical Ctr - Washington D.C.
Florida
- Nemours Chld Clnc Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2027-10-29 |
| Phase | Phase 3 |
What the registry record for NCT05330325 still lists
NCT05330325 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with SGA, Turner Syndrome, Noonan Syndrome, ISS appearing as the primary indexed condition, and to 2 interventions - of which Somapacitan is the first listed.
NCT05330325 names 20 study sites across 14 states, led by California, Colorado, Idaho.
Frequently Asked Questions
What is clinical trial NCT05330325 about?
NCT05330325 is a clinical study titled "A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow". The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new ...
What is the current status of trial NCT05330325?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2022-08-10. Estimated completion is 2027-10-29.
What conditions does trial NCT05330325 study?
This clinical trial studies the following conditions: SGA, Turner Syndrome, Noonan Syndrome, ISS.
What interventions are being tested in trial NCT05330325?
The interventions under investigation include: Somapacitan (DRUG), Norditropin® (DRUG).
Who is sponsoring clinical trial NCT05330325?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05330325 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05330325's enrollment target sits among peer trials
412 907th of 2000 higher than 1,092 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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