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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04732416

Collaborator

(none)

Enrollment

Locations

Arm

41.1

Anticipated Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Hyperinsulinism	Drug: HM15136	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Oct 28, 2021

Anticipated Primary Completion Date :

Mar 31, 2025

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HM15136 active Cohort A / Cohort C	Drug: HM15136 Low dose of HM15136/ High dose of HM15136, SC injection, weekly

Arm

Intervention/Treatment

Experimental: HM15136 active

Cohort A / Cohort C

Drug: HM15136

Low dose of HM15136/ High dose of HM15136, SC injection, weekly

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90095
2	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
3	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
4	University Hospital Düsseldorf	Düsseldorf		Germany
5	Otto-von-Guericke-Universitaet Magdeburg	Magdeburg		Germany
6	Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust	London		United Kingdom
7	Central Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child Health	Manchester		United Kingdom

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT04732416

Other Study ID Numbers:

HM-GCG-201

First Posted:

Feb 1, 2021

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Congenital Hyperinsulinism

Nesidioblastosis

Hyperinsulinism

Study Results

No Results Posted as of Jul 22, 2022