NCT03941236

Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism

An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 5 Weeks – 13 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with Congenital Hyperinsulinism (CHI) who completed either ZP4207-17103 or ZP4207-17109 (defined as lead-in trials). The primary objective is to evaluate the long-term safety of dasiglucagon administered as a subcutaneous (SC) infusion in children with CHI.

Conditions

• Congenital Hyperinsulinism

Interventions

Type	Name	Description
DRUG	dasiglucagon	Glucagon analog

Timeline

• Start date: 2019-05-02
• Primary completion: 2025-01-28
• Completion: 2026-12-31
• First posted: 2019-05-07
• Last updated: 2026-01-20

Locations

10 sites across 4 countries: United States, Germany, Israel, United Kingdom

Regulatory

• FDA-regulated drug study