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

Primary Purpose

Congenital Hyperinsulinism

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

HM15136

About this trial

This is an interventional treatment trial for Congenital Hyperinsulinism

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of California Los AngelesRecruiting
Washington University School of Medicine
The Children's Hospital of PhiladelphiaRecruiting
University Hospital Düsseldorf
Otto-von-Guericke-Universitaet MagdeburgRecruiting
Hadassah Medical Center (HMC)Recruiting
Great Ormond Street Hospital (GOSH) for Children NHS Foundation TrustRecruiting
Central Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HM15136 active

Arm Description

Cohort A / Cohort C

Outcomes

Primary Outcome Measures

Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0

Number of incidence of clinical laboratory abnormalities

Maximum Serum Concentration [Cmax]

Time to reach Cmax

Secondary Outcome Measures

Full Information

NCT ID

NCT04732416

First Posted

January 20, 2021

Last Updated

March 6, 2023

Sponsor

Hanmi Pharmaceutical Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT04732416

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 28, 2021 (Actual)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Hyperinsulinism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HM15136 active

Arm Type

Experimental

Arm Description

Cohort A / Cohort C

Intervention Type

Drug

Intervention Name(s)

HM15136

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0

Time Frame

after multiple subcutaneous (SC) doses of 8 weeks

Title

Number of incidence of clinical laboratory abnormalities

Time Frame

after multiple subcutaneous (SC) doses of 8 weeks

Title

Maximum Serum Concentration [Cmax]

Time Frame

after multiple subcutaneous (SC) doses of 8 weeks

Title

Time to reach Cmax

Time Frame

after multiple subcutaneous (SC) doses of 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JinHee Byeon

Phone

+82 2 410 0485

jinhee.byeon@hanmi.co.kr

Facility Information:

Facility Name

University of California Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erin Okawa

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Terminated

Facility Name

The Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicole Carter

carternd@chop.edu

First Name & Middle Initial & Last Name & Degree

Diva De Leon-Crutchlow

Facility Name

University Hospital Düsseldorf

City

Düsseldorf

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sebastian Kummer

Facility Name

Otto-von-Guericke-Universitaet Magdeburg

City

Magdeburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Klaus Mohnike

Facility Name

Hadassah Medical Center (HMC)

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Zangen

Facility Name

Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust

City

London

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonia Dastamani

Facility Name

Central Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child Health

City

Manchester

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Indi Banerjee

12. IPD Sharing Statement

Learn more about this trial

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

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