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

Open to people ages 2 years and up

• 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%

• 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