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

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · Jan 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HM15136 for children and adults aged 2 years and older who have a condition called Congenital Hyperinsulinism (CHI). CHI causes the body to produce too much insulin, leading to low blood sugar levels, or hypoglycemia, even when patients are already receiving standard treatments. The researchers want to see if HM15136 can help these patients feel better by reducing their hypoglycemic episodes when taken in addition to their current medications.

To participate in the trial, individuals must be at least 2 years old and still experiencing low blood sugar despite being on standard treatments. They should have stable treatment plans and must not have diabetes or other specific medical conditions that could affect their blood sugar. Participants will receive HM15136 once a week for eight weeks and will be closely monitored for safety and how well the treatment works. This trial is currently looking for volunteers, and your involvement could help advance our understanding of how to treat CHI more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects aged ≥2 years with CHI with persistent hypoglycemia despite current SoC treatment according to the investigator's evaluation or documentation
• • Stable therapy with SoC medications with or without nutritional supplementation
• • Previously undergone near-total pancreatectomy or being treated with a nonsurgical approach, having been evaluated as not eligible for pancreatic surgery
• • HbA1c \<7%
• Exclusion Criteria:
• • Subjects with type 1 or type 2 diabetes mellitus
• • Other reasons for hypoglycemia, including but not limited to drug-induced hyperinsulinemic hypoglycemia, etc
• • Treatment of CHI with continuous intravenous glucose or glucagon infusion within 3 months prior to screening
• • Subjects with current use of any drugs that are known to interfere with the study drug, glucose metabolism, or study procedures (eg, use of systemic glucocorticoids \[excluding topical, intra-articular or ophthalmic application, nasal spray, or inhaled forms\] or insulin)
• • Have conditions that could affect glucose levels such as pheochromocytoma, insulinoma, and glucagonoma