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HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment target: estimated 16 to confirmed 17
    • Primary completion date changed from estimate of Jul 2026 to Jun 16, 2026
    v19
  2. Primary completion date: Dec 31, 2025 to Jul 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2025 to May 2027
    • Study sites revised (7)
    v18
  3. Primary and study completion dates: Mar 31, 2025 to Dec 31, 2025
    • Start date: Oct 28, 2021 to May 5, 2022
    v17
  4. Study title expanded, about 1 wordv16
  5. Study sites: 8 to 7v15
Show 13 earlier versionsHide 13 earlier versions
  1. Site details revised at 1 of 8 sitesv14
  2. Study sites: 7 to 8v13
  3. Study sites: 8 to 7v12
  4. Site details revised at 4 of 8 sitesv11
  5. Study sites: 7 to 8v10
  6. Primary completion date: Dec 14, 2022 to Mar 31, 2025
    • Study completion date: Apr 14, 2023 to Mar 31, 2025
    • Site details revised at 1 of 7 sites
    v9
  7. Re-verified, no change to tracked fieldsv8
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2022 to Oct 28, 2021
    • Site details revised at 7 of 7 sites
    v7
  9. Start date: Oct 30, 2021 to Apr 1, 2022v6
  10. Start date: Jun 5, 2021 to Oct 30, 2021
    • Study sites: 0 to 7
    v5
  11. 3 versions Re-verified since Feb 3, 2021, no change to tracked fieldsv2-v4
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04732416
Lead Sponsor Hanmi Pharmaceutical Company Limited
Conditions
(from sponsor)		 Congenital Hyperinsulinism
Related terms Congenital Hyperinsulinism
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov