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Glucagon Receptor Agonist

Dasiglucagon for Congenital Hyperinsulinism

Phase 3
Waitlist Available
Research Sponsored by Zealand Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through treatment completion, up to 3 years
Awards & highlights

Study Summary

This trial is for children with Congenital Hyperinsulinism who have completed either ZP4207-17103 or ZP4207-17109. The objective is to evaluate the long-term safety of dasiglucagon administered as a subcutaneous infusion.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, low blood sugar events (hypoglycemia), and other adverse effects noted during previous studies. The exact profile will be monitored over time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through treatment completion, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through treatment completion, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Secondary outcome measures
Amount of gastric carbohydrates administered to treat hypoglycemia
Clinically significant episodes of hypoglycemia
Diazoxide dose
+12 more

Side effects data

From 2018 Phase 3 trial • 112 Patients • NCT03216226
47%
Hypoglycemia
46%
Nausea
21%
Vomiting
14%
Headache
11%
Viral upper respiratory tract infection
7%
Diarrhea
5%
Hyperglycemia
4%
Upper respiratory tract infection
4%
Leukocytosis
4%
Dizziness
4%
Hypotension
2%
Fatigue
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dasiglucagon (ZP4207)
GlucaGen

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dasiglucagon open-labelExperimental Treatment1 Intervention
Dasiglucagon treatment as sc infusion starting at 10 µg/hr on top of standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dasiglucagon
2018
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Zealand PharmaLead Sponsor
37 Previous Clinical Trials
2,734 Total Patients Enrolled
3 Trials studying Congenital Hyperinsulinism
68 Patients Enrolled for Congenital Hyperinsulinism
Benedikte BandakStudy DirectorZealand Pharma
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Congenital Hyperinsulinism
32 Patients Enrolled for Congenital Hyperinsulinism
Have Andersen Aliu, MSc, PhDStudy DirectorZealand Pharma
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Congenital Hyperinsulinism
12 Patients Enrolled for Congenital Hyperinsulinism

Media Library

Dasiglucagon (Glucagon Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03941236 — Phase 3
Congenital Hyperinsulinism Research Study Groups: Dasiglucagon open-label
Congenital Hyperinsulinism Clinical Trial 2023: Dasiglucagon Highlights & Side Effects. Trial Name: NCT03941236 — Phase 3
Dasiglucagon (Glucagon Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03941236 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other scientific articles that mention dasiglucagon?

"dasiglucagon was first studied in the year 2019 at Great Osmond Street Hospital for Children NHS Foundation Trust. So far there are 14 completed studies. There are presently 4 live studies, with many of these trials based in Philadelphia, Pennsylvania."

Answered by AI

To what extent do I fit the profile of patients that this research is seeking?

"44 individuals are being recruited for this study that require treatment for congenital hyperinsulinism. To be eligible, patients must be between 6 weeks and 13 years old."

Answered by AI

Does this research include young adults in the age demographic?

"This trial is open to anyone who is under 13 years old and has been at least 6 weeks old."

Answered by AI

Are there any reported side effects of dasiglucagon?

"Dasiglucagon's safety has been clinically supported in multiple ways, so it received a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
2019. "Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03941236.
~5 spots leftby Jan 2025
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