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ACTIVE NOT RECRUITING Phase 3

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

NCT03941236 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG dasiglucagon

Study Locations (10)

Other

  • University Hospital Düsseldorf, Department of Pediatrics — Düsseldorf
  • Otto von Guericke University Magdeburg, Department of Pediatrics — Magdeburg
  • Hadassah Medical Center — Jerusalem
  • 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

Colorado

  • Children's Hospital Colorado — Aurora

Pennsylvania

  • The Children's Hospital of Philadelphia — Philadelphia

Texas

  • Cook Children's Endocrinology and Diabetes Clinic — Fort Worth

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2019-05-02
Est. Completion 2026-12-31
Phase Phase 3

Sponsor

Zealand Pharma

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03941236

The ClinicalTrials.gov registry entry for NCT03941236 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zealand Pharma, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 1 intervention — of which dasiglucagon is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03941236 reports 10 study locations spanning 4 distinct geographic areas — top geographies include Other, Colorado, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03941236 about?

NCT03941236 is a clinical study titled "Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in 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 or ZP4207-17109 (defined as lead-in trials). The primary objective is to evaluate the long-term safety of dasiglucagon...

What is the current status of trial NCT03941236?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2019-05-02. Estimated completion is 2026-12-31.

What conditions does trial NCT03941236 study?

This clinical trial studies the following conditions: Congenital Hyperinsulinism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03941236?

The interventions under investigation include: dasiglucagon (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03941236?

This trial is sponsored by Zealand Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03941236 being conducted?

This trial has 10 study locations across Colorado, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial