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HM15136 for Congenital Hyperinsulinism

Phase 2
Recruiting
Research Sponsored by Hanmi Pharmaceutical Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously undergone near-total pancreatectomy or being treated with a nonsurgical approach, having been evaluated as not eligible for pancreatic surgery
Male and female subjects aged ≥2 years with CHI with persistent hypoglycemia despite current SoC treatment according to the investigator's evaluation or documentation
Must not have
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)
Subjects with type 1 or type 2 diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new drug to see if it's safe and works well to treat people with a certain type of diabetes who have low blood sugar. The drug will be given once a week in different doses to people of different ages.

Who is the study for?
This trial is for individuals aged 2 years or older with Congenital Hyperinsulinism who still have low blood sugar despite current treatments. They may have had surgery or be managed without it, and must not have diabetes or use medications that affect blood sugar levels.
What is being tested?
The study tests HM15136 as an additional weekly treatment to see if it's safe and effective in managing low blood sugar in patients with CHI. It will also look at how the body processes the drug across different ages.
What are the potential side effects?
While specific side effects of HM15136 are not listed, common concerns may include reactions at injection sites, potential liver issues, and possible interactions with other drugs affecting glucose metabolism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had most of my pancreas removed or am being treated without surgery because I can't have pancreatic surgery.
Select...
I am 2 years or older with CHI and still have low blood sugar despite treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not currently using any medications that could affect the study drug or my blood sugar levels.
Select...
I have type 1 or type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HM15136 activeExperimental Treatment1 Intervention
Cohort 1 / Cohort 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HM15136
2019
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Hanmi Pharmaceutical Company LimitedLead Sponsor
195 Previous Clinical Trials
62,038 Total Patients Enrolled

Media Library

HM15136 Clinical Trial Eligibility Overview. Trial Name: NCT04732416 — Phase 2
Congenital Hyperinsulinism Research Study Groups: HM15136 active
Congenital Hyperinsulinism Clinical Trial 2023: HM15136 Highlights & Side Effects. Trial Name: NCT04732416 — Phase 2
HM15136 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732416 — Phase 2
~1 spots leftby Mar 2025
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