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

Congenital Hyperinsulinism Clinical Trial

Official title:

A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04732416
• Other study ID #: HM-GCG-201
• Status: Recruiting
• Phase: Phase 2
• Start date: October 28, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Hanmi Pharmaceutical Company Limited
• Contact: JinHee Byeon
• Phone: +82 2 410 0485
• Email: jinhee.byeon[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Hyperinsulinism
• Nesidioblastosis

Intervention

Drug:
• HM15136
Low dose of HM15136/ High dose of HM15136, SC injection, weekly

Locations

Country	Name	City	State
Germany	Otto-von-Guericke-Universitaet Magdeburg	Magdeburg
Israel	Hadassah Medical Center (HMC)	Jerusalem
United Kingdom	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 States	University of California Los Angeles	Los Angeles	California
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Countries where clinical trial is conducted

United States,  Germany,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0		after multiple subcutaneous (SC) doses of 8 weeks
Primary	Number of incidence of clinical laboratory abnormalities		after multiple subcutaneous (SC) doses of 8 weeks
Primary	Maximum Serum Concentration [Cmax]		after multiple subcutaneous (SC) doses of 8 weeks
Primary	Time to reach Cmax		after multiple subcutaneous (SC) doses of 8 weeks