Study of Lonapegsomatropin for Short Stature or Growth Failure

This study is looking at how well a once-weekly injection called lonapegsomatropin (SKYTROFA®) works compared to a daily injection called somatropin. It's for children and teenagers aged 2 to 17 who have short stature or growth problems due to conditions like Turner Syndrome, SHOX gene mutation, Idiopathic Short Stature (unexplained short stature), or being Small for Gestational Age (born smaller than average). The main goal is to see how much children grow in a year (Annualized Height Velocity) after 52 weeks of treatment. About 186 participants will join this study, which is taking place in several countries, including the United States.

Study design
This interventional study will enroll approximately 186 participants. Participants will be randomly assigned to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year.
What's involved
Participants will receive either a once-weekly subcutaneous injection of lonapegsomatropin or a once-daily subcutaneous injection of somatropin. The study duration for each participant will be either 1 or 2 years, depending on the assigned treatment group.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Annualized Height Velocity, is measured at 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221851

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

Recruiting
PHASE3Ages 2–17InterventionalTreatment
Ascendis Pharma A/S
~186 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:Lonapegsomatropin [SKYTROFA®]Somatropin Pen Injector

At a glance

Recruiting sites
43 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized Height Velocity (AHV) (cm/year)
Measured over 52 Weeks
Turner Syndrome
Short Stature Homeobox Gene Mutation
Idiopathic Short Stature
Small for Gestational Age at Delivery

NCT07221851

Where you'd take part

This study runs at 43 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascendis Pharma Investigational Site

    Palo Alto, Californiano site contact published

    Recruiting

  • Ascendis Pharma Investigational Site

    Sacramento, Californiano site contact published

    Recruiting

  • Ascendis Pharma Investigational Site

    Aurora, Coloradono site contact published

    Recruiting

  • Ascendis Pharma Investigational Site

    Centennial, Coloradono site contact published

    Recruiting

  • Ascendis Pharma Investigational Site

    Wilmington, Delawareno site contact published

    Recruiting

  • Ascendis Pharma Investigational Site

    Orlando, Floridano site contact published

    Recruiting

  • Ascendis Pharma Investigational Site

    St. Petersburg, Floridano site contact published

    Recruiting

  • Ascendis Pharma Investigational Site

    Atlanta, Georgiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Medical Director, MD · STUDY_DIRECTOR · Ascendis Pharma A/S

Opens a ready-to-send draft in your own email app — review before sending.

  • Annualized Height Velocity (AHV) (cm/year)52 Weeks

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