Dasiglucagon for Congenital Hyperinsulinism

Recruiting at 9 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Zealand Pharma

Disqualifiers: New complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the long-term safety of dasiglucagon, an injectable medication, in children with Congenital Hyperinsulinism (CHI). Dasiglucagon works by raising blood sugar levels through prompting the liver to release stored sugar. Dasiglucagon is stable and well-absorbed, lasting longer in the body compared to traditional treatments.

Research Team

Jelena Ivkovic, MD

Principal Investigator

Zealand Pharma

Eligibility Criteria

This trial is for children with Congenital Hyperinsulinism who completed prior trials ZP4207-17103 or ZP4207-17109. They should continue to benefit from dasiglucagon, without new conditions or complications that would prevent safe participation as judged by the investigator.

Inclusion Criteria

My doctor thinks dasiglucagon treatment is good for me considering its benefits and side effects.

Completed treatment in either Trial ZP4207-17103 or ZP4207-17109

Exclusion Criteria

The patient developed any conditions prohibited by the lead-in trial

I need to take medication that is not allowed in the trial.

The patient has other new complications that preclude participation in the investigator's opinion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dasiglucagon as a subcutaneous infusion starting at 10 µg/hr on top of standard of care

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Long-term safety and efficacy of dasiglucagon are evaluated in children with CHI

Long-term

Treatment Details

Interventions

• Dasiglucagon

Trial Overview The trial tests the long-term safety and effectiveness of dasiglucagon, a medication given through under-the-skin injections, in managing blood sugar levels in children with Congenital Hyperinsulinism.

Participant Groups

Group I: Dasiglucagon open-label Experimental Treatment 1 Intervention

Dasiglucagon treatment as sc infusion starting at 10 µg/hr on top of standard of care

Who Is Running the Clinical Trial?

Zealand Pharma

Lead Sponsor

Trials

41

Recruited

3,400+