A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

This study is looking for children between 2.5 and 11 years old who were born smaller than most babies and are still shorter than average for their age. For boys, they need to be pre-pubertal, meaning their body is not yet starting to develop into an adult. This is checked by a doctor looking at their testicles. For girls, they also need to be pre-pubertal, meaning there are no signs of breast development yet.

Children who have already received growth hormone or similar treatments in the past cannot join this study. Also, children with other medical conditions that might affect their growth, or those taking other medicines that could interfere with growth, generally won't be able to participate. This includes certain inflammatory conditions, specific hormone problems, or some treatments for ADHD, especially if they have been used for a long time or at high doses.

If your child joins this study, they will receive either a once-a-week injection of somapacitan or a once-a-day injection of Norditropin®. The treatment they receive will be chosen randomly, and you and your study doctor will know which one it is. The study involves regular visits to the clinic for assessments, which will include measurements of your child's height and weight, and possibly blood tests.

The study is planned to last for a long time, around five years. During this period, your child will continue to receive their assigned medication and attend scheduled follow-up appointments. These visits are important to monitor their growth, check for any side effects, and make sure the treatment is working as expected. You will be given full instructions on how to administer the injections at home.