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Congenital HyperinsulinismPhase 3NCT03941236

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

A Phase 3 study testing dasiglucagon in people with Congenital Hyperinsulinism, run by Zealand Pharma at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 (NCT04172441) or ZP4207-17109 (NCT03777176) (defined as lead-in trials). Read more about this study

Who is it for?
Ages 5 weeks to 13 years
Conditions the study is for
Congenital Hyperinsulinism
What is being tested?
dasiglucagon
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
10 sitesin 4 countries
Study dates
2 May 2019to 26 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 weeks to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

United Kingdom4 sites

  • NHS Greater Glasgow and Clyde

    Glasgow

  • Alder Hey Children's Hospital NHS Foundation Trust

    Liverpool

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London

  • Manchester University NHS Foundation Trust

    Manchester

Other trials in United Kingdom

United States3 sites

  • Children's Hospital Colorado

    Aurora, Colorado, 80045-7106

  • Cook Children's Endocrinology and Diabetes Clinic

    Fort Worth, Texas, 76104-2710

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Germany2 sites

  • University Hospital Düsseldorf, Department of Pediatrics

    Düsseldorf, 40225

  • Otto von Guericke University Magdeburg, Department of Pediatrics

    Magdeburg, 39120

Other trials in Germany

Israel1 site

  • Hadassah Medical Center

    Jerusalem, 9765422

Other trials in Israel

About this study

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

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 (NCT04172441) or ZP4207-17109 (NCT03777176) (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.

Being tested
dasiglucagon
Medical subject headings
Congenital Hyperinsulinism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dasiglucagonDrug

    Also called ZP4207

    Glucagon analog

Study groups in NCT03941236
Study groupRoleWhat they receive
Dasiglucagon open-labelExperimentalDasiglucagon treatment as an SC infusion in the dose range 10-70 μg/h titrated individually
Receives: Drug: dasiglucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline through treatment completion, up to 3 years

Secondary outcomes (15)

  1. Amount of gastric carbohydrates administered to treat hypoglycemia

    Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia

    Measured: Baseline through treatment completion, up to 3 years

  2. Nasogastric (NG) tube or gastrostomy removal

    Time to removal of NG tube or gastrostomy

    Measured: Baseline through treatment completion, up to 3 years

  3. Pancreatic surgery

    Time to pancreatic surgery (sub-total or total pancreatectomy)

    Measured: Baseline through treatment completion, up to 3 years

  4. Time in hypoglycemia

    Continuous glucose monitoring (CGM) percent time <70 mg/dL (3.9 mmol/L)

    Measured: Baseline through treatment completion, up to 3 years

  5. Hypoglycemia episodes

    Rate of CGM-detected hypoglycemia episodes <70 mg/dL (3.9 mmol/L) for 15 minutes or more

    Measured: Baseline through treatment completion, up to 3 years

  6. Clinically significant episodes of hypoglycemia

    Rate of clinically significant CGM-detected hypoglycemia episodes <54 mg/dL (3.0 mmol/L) for 15 minutes or more

    Measured: Baseline through treatment completion, up to 3 years

  7. Gastric carbohydrate administrations

    Number of gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia

    Measured: Baseline through treatment completion, up to 3 years

  8. Nightly gastric carbohydrate administrations

    Number of nightly (midnight to 6 am) gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia

    Measured: Baseline through treatment completion, up to 3 years

  9. Extent of hypoglycemia

    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitoring (CGM)

    Measured: Baseline through treatment completion, up to 3 years

  10. Extent of clinically significant hypoglycemia

    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 54 mg/dL [3.0 mmol/L]) as measured by continous glucose monitoring (CGM)

    Measured: Baseline through treatment completion, up to 3 years

  11. Diazoxide dose

    Reduction in diazoxide dose in mg/kg body weight/day from start of lead-in trial

    Measured: Baseline through treatment completion, up to 3 years

  12. Somatostatin analog dose

    Reduction in somatostatin analog dose from start of lead-in trial

    Measured: Baseline through treatment completion, up to 3 years

  13. Prescribed amount of continuous gastric carbohydrate administration

    Change in total amount of prescribed continuous gastric carbohydrate administration from start of lead-in trial (g/day)

    Measured: Baseline through treatment completion, up to 3 years

  14. Prescribed duration of continuous gastric carbohydrate administration

    Change in prescribed duration of infusion of continuous gastric carbohydrate administration from start of lead-in trial (h/day)

    Measured: Baseline through treatment completion, up to 3 years

  15. Prescribed duration of nightly continuous gastric carbohydrate administration

    Change in prescribed duration of infusion of nightly (8 pm - 8 am) continuous gastric carbohydrate administration from start of lead-in trial (h/day)

    Measured: Baseline through treatment completion, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2019
  2. Study start2 May 2019
  3. Primary completion28 Jan 2025
  4. Study completion26 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941236
Sponsor's protocol ID
ZP4207-17106
Status last verified
Jul 2026
First submitted
2 May 2019
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dasiglucagon in people with Congenital Hyperinsulinism, run by Zealand Pharma at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom, United States, Germany, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Baseline through treatment completion, up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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