Trials / Recruiting
RecruitingNCT04732416
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Hanmi Pharmaceutical Company Limited · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HM15136 | Low dose of HM15136/ High dose of HM15136, SC injection, weekly |
Timeline
- Start date
- 2022-05-05
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2021-02-01
- Last updated
- 2025-02-21
Locations
7 sites across 5 countries: United States, Germany, Israel, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04732416. Inclusion in this directory is not an endorsement.