This study is looking at children aged 3 to 11 who have idiopathic short stature (ISS), meaning they are significantly shorter than average for their age and sex without a clear medical reason. The study aims to see how effective vosoritide injection is at helping children grow, compared to a placebo (an inactive substance) or human growth hormone (hGH). Researchers will measure changes in growth speed and overall height over 6 months and up to 4 years to see if vosoritide helps children grow taller. To join, children must have a height Z-score of -2.25 or less and be in Tanner Stage I (early puberty) if they are 5 years or older.

Study design

This is an interventional study with a planned enrollment of 100 participants. It compares vosoritide, human growth hormone, and a placebo.

What's involved

Participants will have an initial observation period of at least 6 months. After that, they will receive treatment for at least 6 months, with some continuing treatment until they reach near-final adult height or a certain age.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for changes in height for up to 4 years. If treatment is discontinued, follow-up assessments may continue per the protocol schedule.

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