Status:
RECRUITING
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Congenital Hyperinsulinism
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief 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 stand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04732416
Start Date
May 5 2022
End Date
December 31 2025
Last Update
February 21 2025
Active Locations (7)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany
4
Hadassah Medical Center (HMC)
Jerusalem, Israel