HM15136 for the Treatment of Congenital Hyperinsulinism Research Study
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Description
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.
Eligibility and criteria
What to expect
The study includes up to 13 visits (11 outpatient and 2 inpatient) over a period of up to 22 weeks as described below.
- Screening Visit: This visit helps us determine if you are eligible for the study. We will ask you questions about your medical history, take blood and urine samples, do a physical exam (with vitals and alcohol breath test), and have you complete an ECG.
- Run-in Visits (if you meet study requirements): You will continue to receive your current HI medications; repeat some of the procedures from the screening visit and be given a glucose meter, CGM, and eDiary to wear/complete throughout the rest of the study.
- Baseline Visits: You will repeat procedures from the previous visits as well as completing questionnaires.
- Treatment Visits: You will receive study drug once a week at the inpatient and outpatient visits during the 8-week treatment period during which previous study visit procedures will be repeated.
- Follow-up Period: After completing study drug treatment, you will be asked to complete two follow-up visits. If you changed your standard of care treatment or nutritional supplementation during the Treatment Visits, you will return to your previous treatment, as instructed by the study doctor. You will have previous tests and procedures repeated.
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Related conditions
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