HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

To be considered for this study, you or your child must be at least 2 years old and have a diagnosis of congenital hyperinsulinism (CHI). It's important that you are still experiencing episodes of low blood sugar despite already receiving your usual care for CHI.

Your current CHI treatment, which might include medication or nutritional support, needs to be stable. This means no recent changes in your regular medicines or diet for CHI. People who have had a near-total pancreatectomy (a surgery to remove part of the pancreas) or those who are managing their CHI without surgery because it wasn't an option for them can be included. Your long-term blood sugar control, measured by a test called HbA1c, should be below 7%.

However, some conditions would mean you cannot join the study. For example, if you have type 1 or type 2 diabetes, or if your low blood sugar is caused by other medical reasons or certain medications. You also can't have received continuous intravenous glucose or glucagon infusions within the last three months, or be taking certain drugs that might interfere with the study medication or affect your blood sugar levels.

If you decide to take part, you or your child will receive the study medicine, HM15136, once a week for eight weeks. This medicine will be given in addition to your current regular treatment for congenital hyperinsulinism. During the study, you'll have regular visits with the study team. These visits will involve health checks, blood tests to monitor your blood sugar and how your body is responding to the medicine, and discussions about how you're feeling and any side effects you might experience. The total duration of active treatment and follow-up will be carefully explained to you by the study team, along with all the assessments involved.