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)

Hanmi Pharmaceutical Company Limited7 sites in 5 countries16 target enrollmentMay 5, 2022

ConditionsCongenital Hyperinsulinism

InterventionsHM15136

DrugsHM15136

Overview

Phase: Phase 2
Intervention: HM15136
Conditions: Congenital Hyperinsulinism
Sponsor: Hanmi Pharmaceutical Company Limited
Enrollment: 16
Locations: 7
Primary Endpoint: Time to reach Cmax
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

May 5, 2022

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Hanmi Pharmaceutical Company Limited

Responsible Party

Sponsor

Eligibility Criteria

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