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Active, not recruiting Phase 2

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

NCT04732416 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2022-05-05
Last updated
2026-08-26

Condition(s) studied

Congenital Hyperinsulinism

Investigational drug(s) / intervention(s)

HM15136

HM15136: Low dose of HM15136/ High dose of HM15136, SC injection, weekly

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0 — after multiple subcutaneous (SC) doses of 8 weeks
  • Number of incidence of clinical laboratory abnormalities — after multiple subcutaneous (SC) doses of 8 weeks
  • Maximum Serum Concentration [Cmax] — after multiple subcutaneous (SC) doses of 8 weeks
  • Time to reach Cmax — after multiple subcutaneous (SC) doses of 8 weeks

Trial sites (7)

FacilityCityRegionStatus
The Children's Hospital of Philadelphia Philadelphia Pennsylvania
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04732416 on ClinicalTrials.gov ↗ ← All trials in South Korea