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RECRUITING
NCT04732416
PHASE2

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

Sponsor: Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

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

Interventions

DRUG

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