Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Erin Okawa (ucla)

Description

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.

Official Title

A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

Keywords

Congenital Hyperinsulinism Nesidioblastosis Hyperinsulinism

Eligibility

You can join if…

Open to people ages 2 years and up

  • 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 CAN'T join 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

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Washington University School of Medicine accepting new patients
    Saint Louis Missouri 63110 United States

Lead Scientist at University of California Health

  • Erin Okawa (ucla)
    HS Assistant Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 19 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hanmi Pharmaceutical Company Limited
ID
NCT04732416
Phase
Phase 2 Congenital Hyperinsulinism Research Study
Study Type
Interventional
Participants
Expecting 16 study participants
Last Updated