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
← catalyst calendarNCT07221851 · readout ≤ 559 d
Sponsored by Ascendis Pharma A/S (industry) · ASND — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
186estimated
Sites
40
Countries
France, Germany, Italy +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-12 | actual | When the study began enrolling |
| Primary completion | Feb 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Turner Syndrome
- Short Stature Homeobox Gene Mutation
- Idiopathic Short Stature
- Small for Gestational Age at Delivery
Interventions
- Combination product: Lonapegsomatropin [SKYTROFA®]
- Combination product: Somatropin Pen Injector
Primary outcome
what the primary-completion date above is the date OFAnnualized Height Velocity (AHV) (cm/year)
measured 52 Weeks
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