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NCT Number: NCT04732416

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Congenital Hyperinsulinism Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Infant, Newborn, Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Otto-von-Guericke-Universitaet Magdeburg, Magdeburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM15136

Drug

Low dose of HM15136/ High dose of HM15136, SC injection, weekly

Primary outcomes

  1. Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0

    Time frame: after multiple subcutaneous (SC) doses of 8 weeks

  2. Number of incidence of clinical laboratory abnormalities

    Time frame: after multiple subcutaneous (SC) doses of 8 weeks

  3. Maximum Serum Concentration [Cmax]

    Time frame: after multiple subcutaneous (SC) doses of 8 weeks

  4. Time to reach Cmax

    Time frame: after multiple subcutaneous (SC) doses of 8 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2021
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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