Congenital Hyperinsulinism clinical trials
The registry lists 38 studies for Congenital Hyperinsulinism across more than 10 countries. 6 are recruiting or about to start. 34 of them are mainly about Congenital Hyperinsulinism (how this is decided). Per ClinicalTrials.gov, last updated 2026-08-31. Counting its narrower condition Nesidioblastosis too: 39 studies, 5 open.
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Status
Who runs them
Zealand Pharma (3) · Diva De Leon (3) · Children's Hospital of Philadelphia (3) · Xeris Pharmaceuticals (2) · Montefiore Medical Center (2) · University of Minnesota (2) · University of Alberta (2) · Rezolute (2)
What is being tested here
Drugs under test in Congenital Hyperinsulinism studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 2
- Nov 2026Early Check: Expanded Screening in Newborns · RTI International
- Dec 202618FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism · Miguel Pampaloni
Who these studies take
Of the 4 Congenital Hyperinsulinism studies recruiting now, 2 (50%) set no upper age limit and 2 (50%) stop at 75 or younger. 3 (75%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 1 (25%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 3 (75%) | 3 (75%) |
| 18 | 4 (100%) | 4 (100%) |
| 30 | 2 (50%) | 2 (50%) |
| 40 | 2 (50%) | 2 (50%) |
| 50 | 2 (50%) | 2 (50%) |
| 65 | 2 (50%) | 2 (50%) |
| 75 | 2 (50%) | 2 (50%) |
| 85 | 2 (50%) | 2 (50%) |
Across all 38 studies, recruiting or not: 66% stop at 75 or younger and 55% at 65; 66% take children; 0% are for women only and 0% for men only; 13% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
Studies
Recruiting first, then most recently updated. Showing 38 of 38. search them.
- Umbilical Cord GlucoseNot yet recruitingNCT07795047Not applicable
- 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital HyperinsulinismRecruitingNCT04205604Phase 21 country
- 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic HypoglycemiaAvailableNCT019161481 country
- 18F-DOPA II - PET Imaging OptimizationRecruitingNCT04706910Phase 31 country
- Fluorodopa F 18 in Congenital Hyperinsulinism and InsulinomaRecruitingNCT02021604Phase 11 country
- GLP1R-imaging in Post-RYGB HypoglycemiaRecruitingNCT05597475Not applicable1 country
- HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)Active, not recruitingNCT04732416Phase 25 countries
- Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital HyperinsulinismCompletedNCT03941236Phase 34 countries
- Early Check: Expanded Screening in NewbornsActive, not recruitingNCT036552231 country
- Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic DisordersCompletedNCT07614139Not applicable1 country
- RZ358 Treatment for Congenital HyperinsulinismActive, not recruitingNCT06208215Phase 313 countries
- Baby Detect : Genomic Newborn ScreeningCompletedNCT056874741 country
- An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital HyperinsulinismCompletedNCT04538989Phase 211 countries
- Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital HyperinsulinismCompletedNCT04172441Phase 2/34 countries
- Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric HypoglycemiaCompletedNCT02996812Phase 11 country
- Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of InfancyCompletedNCT01070758Phase 41 country
- A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital HyperinsulinismCompletedNCT03777176Phase 34 countries
- Treatment of Post-bariatric HypoglycaemiaCompletedNCT04836273Phase 21 country
- Utility of [F-18] fluoroDOPA for Neonatal HyperinsulinismCompletedNCT00674440Phase 21 country
- Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic HypoglycemiaCompletedNCT01468454Phase 21 country
- Compassionate Use of SOM230 for Hyperinsulinemic/HypoglycemiaNo longer availableNCT028351311 country
- 18F-DOPA PET Imaging: an Evaluation of Biodistribution and SafetyCompletedNCT03042416Phase 31 country
- Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic HypoglycemiaCompletedNCT03103009Phase 11 country
- Pasireotide in Hyperinsulinemic HypoglycemiaWithdrawnNCT03053284Phase 2
- Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic HypoglycemiaCompletedNCT02685852Phase 11 country
- Study of the Use of [18F]-DOPA in Hyperinsulinemic HypoglycemiaNo longer availableNCT025332191 country
- Effect of Exendin (9-39) on Glucose Requirements to Maintain EuglycemiaTerminatedNCT00835328Phase 1/21 country
- Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric SurgeryCompletedNCT03770637Phase 21 country
- Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric BypassCompletedNCT03984370Phase 21 country
- Effect of Exendin-(9-39) on Fasting Adaptation and Protein SensitivityCompletedNCT00897676Phase 1/21 country
- CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital HyperinsulinismCompletedNCT02937558Phase 21 country
- Post-Gastric Bypass HypoglycemiaCompletedNCT01933490Not applicable1 country
- Application of Raw Corn Starch on Patients With InsulinomaStatus unknownNCT03930368Not applicable1 country
- GLP-1 Receptor Expression in CHIStatus unknownNCT037685181 country
- Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital HyperinsulinismCompletedNCT00571324Phase 1/21 country
- A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital HyperinsulinismCompletedNCT02604485Phase 22 countries
- Towards Individualized Surgery in Non-focal Congenital HyperinsulinismCompletedNCT021087301 country
- Sandostatine® LP and HyperinsulinismCompletedNCT00987168Phase 21 country