This study is designed for children who have Central Precocious Puberty (CPP), a condition where puberty starts earlier than normal due to hormone activity in the brain. The study is testing a new drug called Debio 4326. Debio 4326, also known as triptorelin, is a drug that blocks or pauses puberty changes. It is a shot that is given once every 12 months under the skin. If your child joins this study, they will come to up to 21 study visits over two and a half years. Your child will get the study drug as a shot in their thigh or buttocks two times, once at the start of the study and a second time, one year later. During the study, we will check your child's height, weight, and vitals. At up to 11 of the visits, they will get a shot of the study drug under their skin and then we will use a needle in their arm to take a small blood sample to test if the study medication is still working. At some visits, they will also give a urine sample. We will use a machine to measure your child's heartbeat. We will also take X-ray pictures of their hand. We will ask about your child's medical history and have you and your child fill out surveys. There may be other optional tests your child will be asked to complete. Details about these tests will be discussed with you if your child joins the study.

Who can Participate

Your child can join this study if they are between 5 and 8 years old and have been diagnosed with central precocious puberty. A doctor will need to perform other tests to make sure they meet all the requirements to join the study.

Study ID