HM15136 for the Treatment of Congenital Hyperinsulinism Research Study

Description

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The
purpose of this study is to look at the safety and tolerability (how well you
will react) of the study drug (HM15136) and to determine if it is effective for
the treatment of Congenital Hyperinsulinism (HI). HM15136 is an experimental
drug which is not approved by the FDA for the treatment of HI. HM15136 is stable and has
a long effect in the body, only requiring it to be given (by injection) once a
week.  HM15136 is designed to act like
glucagon, a hormone produced by the pancreas that helps the body maintain
normal blood sugar levels by increasing the glucose produced in the liver and
breaking down glycogen (a form of stored glucose) into the usable glucose form.

Participation
lasts for up to 22 weeks and will involve up to 13 study visits. Study
procedures include taking the study drug for 8 weeks, having
electrocardiograms, wearing a continuous glucose monitor (CGM) and using a
handheld glucose meter, having blood and urine tests, and completing an
electronic diary.

The
main risks of this study include: nausea, vomiting, diarrhea, abdominal pain,
injection site reactions (swelling, itching, bleeding, or pain), loss of
appetite, weight loss, high blood sugar. You may benefit if the study drug
proves to be more effective than your current treatment plan in treating low
blood sugar.

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