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NCT04732416 · ClinicalTrials.gov registry record · Phase 2
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
A Phase 2 study of Congenital Hyperinsulinism, sponsored by Hanmi Pharmaceutical Company Limited.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 7
- Study locations
NCT04732416: Recruiting Phase 2 study of Congenital Hyperinsulinism, sponsored by Hanmi Pharmaceutical Company Limited.
NCT04732416 is a Phase 2 study of Congenital Hyperinsulinism that is actively recruiting participants, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 16 participants, below the 76-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04732416, a Phase 2 study of Congenital Hyperinsulinism, is actively recruiting participants, sponsored by Hanmi Pharmaceutical Company Limited.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 7
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG HM15136
Study Locations (7)
Other
- Otto-von-Guericke-Universitaet Magdeburg - Magdeburg
- Hadassah Medical Center (HMC) - Jerusalem
- Asan Medical Center - Seoul
- Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust - London
- Central Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child Health - Manchester
California
- University of California Los Angeles - Los Angeles
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-05-05 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What NCT04732416 shows while recruiting
NCT04732416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 76-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 1 intervention - of which HM15136 is the first listed.
NCT04732416 lists 7 locations in 3 states (Other, California, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04732416 about?
NCT04732416 is a clinical study titled "HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)". 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 ...
What is the current status of trial NCT04732416?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2022-05-05. Estimated completion is 2025-12-31.
What conditions does trial NCT04732416 study?
This clinical trial studies the following conditions: Congenital Hyperinsulinism.
What interventions are being tested in trial NCT04732416?
The interventions under investigation include: HM15136 (DRUG).
Who is sponsoring clinical trial NCT04732416?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04732416 being conducted?
This trial has 7 study locations across California, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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