NCT03941236

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
8mo left

Started May 2019

Longer than P75 for phase_3

Geographic Reach
4 countries

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2019Dec 2026

First Submitted

Initial submission to the registry

May 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2025

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5.7 years

First QC Date

May 2, 2019

Last Update Submit

January 9, 2026

Conditions

Congenital Hyperinsulinism

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Number of adverse events occurring up to Month 1, Month 1 to Month 3 and in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis

    Baseline through treatment completion, up to 3 years

Secondary Outcomes (15)

  • Amount of gastric carbohydrates administered to treat hypoglycemia

    Baseline through treatment completion, up to 3 years

  • Nasogastric (NG) tube or gastrostomy removal

    Baseline through treatment completion, up to 3 years

  • Pancreatic surgery

    Baseline through treatment completion, up to 3 years

  • Time in hypoglycemia

    Baseline through treatment completion, up to 3 years

  • Hypoglycemia episodes

    Baseline through treatment completion, up to 3 years

  • +10 more secondary outcomes

Study Arms (1)

Dasiglucagon open-label

EXPERIMENTAL

Dasiglucagon treatment as an SC infusion in the dose range 10-70 μg/h titrated individually +/- standard of care

Drug: dasiglucagon

Interventions

dasiglucagonDRUG

Glucagon analog

Also known as: ZP4207
Dasiglucagon open-label

Eligibility Criteria

Age5 Weeks - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Completed treatment in either Trial ZP4207-17103 or ZP4207-17109
  • Expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon (based on considerations of glycemic effect, tolerability, and nature and frequency of adverse events experienced in the lead-in trial)

You may not qualify if:

  • The patient developed any conditions prohibited by the lead-in trial, requires medication prohibited by the lead-in trial, or has other new complications that preclude participation in the investigator's opinion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Children's Hospital Colorado

Aurora, Colorado, 80045-7106, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Cook Children's Endocrinology and Diabetes Clinic

Fort Worth, Texas, 76104-2710, United States

Location

University Hospital Düsseldorf, Department of Pediatrics

Düsseldorf, 40225, Germany

Location

Otto von Guericke University Magdeburg, Department of Pediatrics

Magdeburg, 39120, Germany

Location

Hadassah Medical Center

Jerusalem, 9765422, Israel

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Alder Hey Children's Hospital NHS Foundation Trust

Liverpool, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Congenital Hyperinsulinism

Interventions

dasiglucagon

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypoglycemia

Study Officials

  • Clinical Trial Information Desk

    Zealand Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 7, 2019

Study Start

May 2, 2019

Primary Completion

January 28, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)IL(1)US(3)GB(4)