This clinical trial is focused on children with short stature, which means they are shorter than most children their age. The study includes children who were either born small for their age, or have conditions like Turner syndrome, Noonan syndrome, or idiopathic short stature, which means the cause of their short stature is unknown. The trial is testing a new treatment called somapacitan, which is given once a week, and comparing it to a daily treatment called Norditropin®. Both treatments are designed to help children grow taller.
The purpose of the study is to see if the once-weekly somapacitan is as effective as the daily Norditropin® in helping children grow. The study will last for a period of time, during which children will receive either somapacitan or Norditropin®. The somapacitan is administered using a special pen-injector called the PDS290 pen-injector, which is a pre-filled device that makes it easier to give the injection. The study will monitor the children’s growth over time, specifically looking at how fast they grow in height.
Throughout the study, researchers will also keep an eye on the long-term safety of somapacitan. They will measure various health indicators, such as changes in bone age and levels of certain substances in the blood, like IGF-I and IGFBP-3, which are related to growth. The study aims to provide valuable information on whether somapacitan can be a safe and effective option for children with short stature conditions.



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