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CompletedPhase 3

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

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

Lead sponsor

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

10

Recruiting sites

-

Actual enrollment

42

Study population

Prediabetes / glucose intolerance

Eligibility highlights

•Age 5-13

Primary endpoint

•Adverse Events

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03941236

Org study IDZP4207-17106

Timeline

Milestones

Study start2019-05-02actual

Study first posted2019-05-07actual

Primary completion2025-01-28actual

Study completion2026-05-26actual

Last update posted2026-08-03actual

Assets

Investigational agents

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age5 Weeks

Maximum age13 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

9

Safety / tolerability / PK

7

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Adverse Events

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Secondary/protocol endpoint

Amount of gastric carbohydrates administered to treat hypoglycemia

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Secondary/protocol endpoint

Time in hypoglycemia

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Secondary/protocol endpoint

Hypoglycemia episodes

Time frame:Baseline through treatment completion, up to 3 years

event count, event

Secondary/protocol endpoint

Clinically significant episodes of hypoglycemia

Time frame:Baseline through treatment completion, up to 3 years

event count, event

Secondary/protocol endpoint

Extent of hypoglycemia

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Secondary/protocol endpoint

Extent of clinically significant hypoglycemia

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Other (unclassified)

9 endpoints

Secondary/protocol endpoint/low confidence

Nasogastric (NG) tube or gastrostomy removal

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Secondary/protocol endpoint/low confidence

Pancreatic surgery

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Secondary/protocol endpoint/low confidence

Gastric carbohydrate administrations

Time frame:Baseline through treatment completion, up to 3 years

ratio, improvement

Secondary/protocol endpoint/low confidence

Nightly gastric carbohydrate administrations

Time frame:Baseline through treatment completion, up to 3 years

ratio, improvement

Secondary/protocol endpoint/low confidence

Diazoxide dose

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Secondary/protocol endpoint/low confidence

Somatostatin analog dose

Time frame:Baseline through treatment completion, up to 3 years

descriptive

Secondary/protocol endpoint/low confidence

Prescribed amount of continuous gastric carbohydrate administration

Time frame:Baseline through treatment completion, up to 3 years

ratio, improvement

Secondary/protocol endpoint/low confidence

Prescribed duration of continuous gastric carbohydrate administration

Time frame:Baseline through treatment completion, up to 3 years

ratio, improvement

Secondary/protocol endpoint/low confidence

Prescribed duration of nightly continuous gastric carbohydrate administration

Time frame:Baseline through treatment completion, up to 3 years

ratio, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.