Clinical Trial

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

Active, Not Recruiting Phase 2
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Record status
This record was last updated May 11, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2021-01-26; most recent amendment 2026-05-07.
Status change: Recruiting → Active, Not Recruiting 2026-05-07
Status change: Not Yet Recruiting → Recruiting 2022-04-01
Trial Details
NCT Number NCT04732416
Lead Sponsor Hanmi Pharmaceutical Company Limited
Conditions Congenital Hyperinsulinism
Enrollment 16 participants
Start Date 2022-05-05
Primary Completion 2026-07 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-11