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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

Study comparing weekly and daily growth hormone treatments for children.

Recruiting
2-17 years
All
Phase 3
This study is for children and teens (ages 2-18) with short height or growth issues due to certain growth hormone problems. It will compare a *new once-a-week medicine called lonapegsomatropin* to a *daily medicine called somatropin*. Participants will either take lonapegsomatropin for two years or somatropin for one year and then switch to lonapegsomatropin for one year. This study is happening in several countries, including the United States and Europe. **Key Points:** - **Duration:** This study lasts for 2 years. - **Treatment:** Participants will receive growth hormone treatment either weekly or daily. - **Eligibility:** Children must not have taken growth hormone treatments before and must be able to stand on their own. Children with certain conditions like Turner Syndrome (TS), Short Stature Homeobox-Containing Gene (SHOX-D), Small for Gestational Age (SGA), or Idiopathic Short Stature (ISS) can join if they meet specific criteria. Participants will have to visit study sites for check-ups and tests, and parents/guardians must consent for their child's participation. The study will ensure the safety and effectiveness of the treatment.
Study details
    Turner Syndrome
    Short Stature Homeobox Gene Mutation
    Idiopathic Short Stature
    Small for Gestational Age at Delivery

NCT07221851

Ascendis Pharma A/S

17 October 2026

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