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New weekly shot shows promise for rare low blood sugar disorder

NCT ID NCT04732416

Disease control Sponsor: Hanmi Pharmaceutical Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests a new medicine called HM15136 for people aged 2 and older with congenital hyperinsulinism (CHI) who still have low blood sugar despite standard treatments. The medicine is given as a weekly shot for 8 weeks. The goal is to see if it is safe and helps control blood sugar levels. About 16 participants will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

17 people

The number who actually took part.

Started

May 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Congenital Hyperinsulinism familial hyperinsulinism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital hyperinsulinism

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

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

    Manchester, United Kingdom

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

    London, United Kingdom

  • Hadassah Medical Center (HMC)

    Jerusalem, Israel

  • Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, Germany

  • Pusan National University Yangsan Hospital

    Pusan, South Korea

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

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