Congenital HyperinsulinismPhase 2NCT04732416
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
A Phase 2 study testing HM15136 in people with Congenital Hyperinsulinism, run by Hanmi Pharmaceutical Company Limited at 7 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Congenital Hyperinsulinism
- What is being tested?
- HM15136
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 5 May 2022to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
South Korea2 sites
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul
United Kingdom2 sites
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
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 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 in multiple age including pediatric to find appropriate exposure-response data.
- Conditions
- Congenital Hyperinsulinism
- Being tested
- HM15136
- Medical subject headings
- Congenital Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM15136Drug
Low dose of HM15136/ High dose of HM15136, SC injection, weekly
| Study group | Role | What they receive |
|---|---|---|
| HM15136 active | Experimental | Cohort 1 / Cohort 2 Receives: Drug: HM15136 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0
Measured: after multiple subcutaneous (SC) doses of 8 weeks
Number of incidence of clinical laboratory abnormalities
Measured: after multiple subcutaneous (SC) doses of 8 weeks
Maximum Serum Concentration [Cmax]
Measured: after multiple subcutaneous (SC) doses of 8 weeks
Time to reach Cmax
Measured: after multiple subcutaneous (SC) doses of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start5 May 2022
- Primary completion16 Jun 2026
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital HyperinsulinismStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732416
- Sponsor's protocol ID
- HM-GCG-201
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
- ClinicalTrials.gov ID
- NCT04732416
- Acronym / sponsor ID
- HM-GCG-201
- Conditions
- Congenital Hyperinsulinism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM15136 active | Experimental | Drug: HM15136Cohort 1 / Cohort 2 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM15136Low dose of HM15136/ High dose of HM15136, SC injection, weekly | Drug | HM15136 active |
Primary outcome
Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0
Time frame: after multiple subcutaneous (SC) doses of 8 weeks
Number of incidence of clinical laboratory abnormalities
Time frame: after multiple subcutaneous (SC) doses of 8 weeks
Maximum Serum Concentration [Cmax]
Time frame: after multiple subcutaneous (SC) doses of 8 weeks
Time to reach Cmax
Time frame: after multiple subcutaneous (SC) doses of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HM15136 in people with Congenital Hyperinsulinism, run by Hanmi Pharmaceutical Company Limited at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea, United Kingdom, United States, Germany, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0 (time frame: after multiple subcutaneous (SC) doses of 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.