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
Public ClinicalTrials.gov record NCT07221851. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07221851
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 186 participants
Conditions and interventions
Conditions
Interventions
- Lonapegsomatropin [SKYTROFA®] Combination Product
- Somatropin Pen Injector Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 2 Years to 17 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
- Dec 11, 2025
- Primary completion
- Jan 31, 2028
- Completion
- Feb 28, 2029
- Last update posted
- Sep 1, 2026
2025 – 2029
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ascendis Pharma Investigational Site | Palo Alto | California | 94304 | Recruiting |
| Ascendis Pharma Investigational Site | Sacramento | California | 95821 | Recruiting |
| Ascendis Pharma Investigational Site | Aurora | Colorado | 80045 | Recruiting |
| Ascendis Pharma Investigational Site | Centennial | Colorado | 80112 | Recruiting |
| Ascendis Pharma Investigational Site | Wilmington | Delaware | 19803 | Recruiting |
| Ascendis Pharma Investigational Site | Orlando | Florida | 32806 | Recruiting |
| Ascendis Pharma Investigational Site | St. Petersburg | Florida | 33701 | Recruiting |
| Ascendis Pharma Investigational Site | Atlanta | Georgia | 30329 | Recruiting |
| Ascendis Pharma Investigational Site | Idaho Falls | Idaho | 83404 | Recruiting |
| Ascendis Pharma Investigational Site | New Orleans | Louisiana | 70118 | Recruiting |
| Ascendis Pharma Investigational Site | Minneapolis | Minnesota | 55454 | Recruiting |
| Ascendis Pharma Investigational Site | Saint Paul | Minnesota | 55102 | Recruiting |
| Ascendis Pharma Investigational Site | Lake Success | New York | 11042 | Recruiting |
| Ascendis Pharma Investigational Site | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Ascendis Pharma Investigational Site | Edinburg | Texas | 78539 | Recruiting |
| Ascendis Pharma Investigational Site | Fort Worth | Texas | 76104 | Recruiting |
| Ascendis Pharma Investigational Site | San Antonio | Texas | 78229 | Recruiting |
| Ascendis Pharma Investigational Site | San Antonio | Texas | 78232 | Recruiting |
| Ascendis Pharma Investigational Site | Seattle | Washington | 98105 | Recruiting |
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 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07221851, 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 Sep 1, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07221851 live on ClinicalTrials.gov.