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HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
Sponsor: Hanmi Pharmaceutical Company Limited
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.
Official title: A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2022-05-05
Completion Date
2025-12-31
Last Updated
2025-02-21
Healthy Volunteers
No
Conditions
Interventions
HM15136
Low dose of HM15136/ High dose of HM15136, SC injection, weekly
Locations (7)
University of California Los Angeles
Los Angeles, California, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany
Hadassah Medical Center (HMC)
Jerusalem, Israel
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