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New drug aims to control blood sugar in kids with rare condition

NCT ID NCT03941236

Disease control Sponsor: Zealand Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 04, 2026 · Updated 5 times

Summary

This study is testing the long-term safety of dasiglucagon, a drug given as a continuous injection under the skin, in children with congenital hyperinsulinism (a condition causing dangerously low blood sugar). The trial includes 42 children who completed earlier studies. Researchers will monitor side effects and check if the drug helps reduce the need for tube feeding or surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dasiglucagon (a glucagon analog given as a continuous injection under the skin)
What this could lead to
If successful, dasiglucagon could provide a long-term treatment option to control blood sugar levels in children with congenital hyperinsulinism, potentially reducing the need for tube feeding or surgery.
What could go wrong
This is an extension trial with no placebo group, so results may be less definitive. The drug may cause side effects, and long-term benefits are not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

42 people

The number who actually took part.

Started

May 2019

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 weeks to 13 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Congenital Hyperinsulinism familial hyperinsulinism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital hyperinsulinism

Contacts and locations

Locations

  • Alder Hey Children's Hospital NHS Foundation Trust

    Liverpool, United Kingdom

  • Children's Hospital Colorado

    Aurora, Colorado, 80045-7106, United States

  • Cook Children's Endocrinology and Diabetes Clinic

    Fort Worth, Texas, 76104-2710, United States

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London, United Kingdom

  • Hadassah Medical Center

    Jerusalem, 9765422, Israel

  • Manchester University NHS Foundation Trust

    Manchester, United Kingdom

  • NHS Greater Glasgow and Clyde

    Glasgow, United Kingdom

  • Otto von Guericke University Magdeburg, Department of Pediatrics

    Magdeburg, 39120, Germany

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • University Hospital Düsseldorf, Department of Pediatrics

    Düsseldorf, 40225, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.