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

Running, not enrolling · Phase 2

Conditions studied: Congenital Hyperinsulinism

In brief

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC). HM15136 will be administered once weekly in multiple doses to subjects in multiple age including pediatric to find appropriate exposure-response data.

Key facts

Study ID

NCT04732416

Run by

Hanmi Pharmaceutical Company Limited

People needed

16

Starts

2022-05-05

Expected to finish

2027-05-01

Last updated by the study team

2026-05-11

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Otto-von-Guericke-Universitaet Magdeburg — Magdeburg, Germany
• Hadassah Medical Center (HMC) — Jerusalem, Israel
• Pusan National University Yangsan Hospital — Pusan, South Korea
• Asan Medical Center — Seoul, South Korea
• Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust — London, United Kingdom
• Central Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child Health — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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