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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: Recruiting Phase 3 study of Turner Syndrome and Idiopathic Short Stature, sponsored by Ascendis Pharma A/S.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To evaluate the efficacy of lonapegsomatropin as compared to somatropin in children and adolescents with TS, SHOX-D, SGA, or ISS

Conditions Studied

Turner Syndrome Idiopathic Short Stature Small for Gestational Age at Delivery Short Stature Homeobox Gene Mutation

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

FieldValue
Enrollment Target 186 participants
Start Date 2025-12-12
Est. Completion 2029-03
Phase Phase 3
Ascendis Pharma A/S

9 total trials

What NCT07221851 shows while recruiting

NCT07221851 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 506-participant average among 14 other Turner Syndrome trials with a reported enrollment target (63% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Turner Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07221851's enrollment target sits among peer trials

186 6th of 14 higher than 9 of 14 other Turner Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Turner Syndrome 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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More recruiting context for NCT07221851

Source: ClinicalTrials.gov NCT07221851, the US trial registry maintained by the National Library of Medicine. NCT07221851 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.