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.
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
At a glance
Conditions
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.
Study leadership
- Medical Director, MD · STUDY_DIRECTOR · Ascendis Pharma A/S
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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