NCT04732416

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2022

Typical duration for phase_2

Geographic Reach
5 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

3.7 years

First QC Date

January 20, 2021

Last Update Submit

February 20, 2025

Conditions

Congenital Hyperinsulinism

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

HM15136 active

EXPERIMENTAL

Cohort 1 / Cohort 2

Drug: HM15136

Interventions

HM15136DRUG

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

HM15136 active

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, Germany

RECRUITING

Hadassah Medical Center (HMC)

Jerusalem, Israel

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

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

London, United Kingdom

RECRUITING

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

Manchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Congenital Hyperinsulinism

Interventions

HM15136

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypoglycemia

Central Study Contacts

JinHee Byeon

CONTACT

+82 2 410 0485jinhee.byeon@hanmi.co.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

February 1, 2021

Study Start

May 5, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)IL(1)KR(1)GB(2)DE(1)