Thepurpose of this study is to look at the safety and tolerability (how well youwill react) of the study drug (HM15136) and to determine if it is effective forthe treatment of Congenital Hyperinsulinism (HI). HM15136 is an experimentaldrug which is not approved by the FDA for the treatment of HI. HM15136 is stable and hasa long effect in the body, only requiring it to be given (by injection) once aweek. HM15136 is designed to act likeglucagon, a hormone produced by the pancreas that helps the body maintainnormal blood sugar levels by increasing the glucose produced in the liver andbreaking down glycogen (a form of stored glucose) into the usable glucose form.
Participationlasts for up to 22 weeks and will involve up to 13 study visits. Studyprocedures include taking the study drug for 8 weeks, havingelectrocardiograms, wearing a continuous glucose monitor (CGM) and using ahandheld glucose meter, having blood and urine tests, and completing anelectronic diary.
Themain risks of this study include: nausea, vomiting, diarrhea, abdominal pain,injection site reactions (swelling, itching, bleeding, or pain), loss ofappetite, weight loss, high blood sugar. You may benefit if the study drugproves to be more effective than your current treatment plan in treating lowblood sugar.
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