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A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
NCT05330325 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05330325
The ClinicalTrials.gov registry entry for NCT05330325 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 412 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05330325 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Colorado, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05330325?
The interventions under investigation include: Somapacitan (DRUG), Norditropin® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05330325?
This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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