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NCT07221851 · ClinicalTrials.gov registry record · Phase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
A Phase 3 study of Turner Syndrome and Idiopathic Short Stature, sponsored by Ascendis Pharma A/S.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 186
- Enrollment target
- 4
- Study locations
NCT07221851 is a Phase 3 study of Turner Syndrome and Idiopathic Short Stature that is actively recruiting participants, run by Ascendis Pharma A/S. The registered enrollment target is 186 participants, below the 506-participant average among 14 other Turner Syndrome trials with a reported enrollment target (63% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT07221851, a Phase 3 study of Turner Syndrome and Idiopathic Short Stature, is actively recruiting participants, sponsored by Ascendis Pharma A/S.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 186 participants
- Enrollment target
- 4
- Study locations
Study Summary
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \<18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Lonapegsomatropin [SKYTROFA®]
- COMBINATION_PRODUCT Somatropin Pen Injector
Study Locations (4)
Colorado
- Ascendis Investigational Site - Centennial
Idaho
- Ascendis Investigational Site - Idaho Falls
Minnesota
- Ascendis Pharma Investigational Site - Saint Paul
Texas
- Ascendis Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2025-12-12 |
| Est. Completion | 2029-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07221851
The ClinicalTrials.gov registry entry for NCT07221851 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 506-participant average among 14 other Turner Syndrome trials with a reported enrollment target (63% lower). The listed sponsor is Ascendis Pharma A/S, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Turner Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Lonapegsomatropin [SKYTROFA®] is the first listed.
NCT07221851 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Colorado, Idaho, Minnesota.
Frequently Asked Questions
What is clinical trial NCT07221851 about?
NCT07221851 is a clinical study titled "Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders". This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \<18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsoma...
What is the current status of trial NCT07221851?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2025-12-12. Estimated completion is 2029-03.
What conditions does trial NCT07221851 study?
This clinical trial studies the following conditions: Turner Syndrome, Idiopathic Short Stature, Small for Gestational Age at Delivery, Short Stature Homeobox Gene Mutation.
What interventions are being tested in trial NCT07221851?
The interventions under investigation include: Lonapegsomatropin [SKYTROFA®] (COMBINATION_PRODUCT), Somatropin Pen Injector (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07221851?
This trial is sponsored by Ascendis Pharma A/S, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07221851 being conducted?
This trial has 4 study locations across Colorado, Idaho, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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