22 completed, 4 unknown, 3 active not recruiting, 3 recruiting. 16 Phase 2, 7 Phase 1, 6 Phase 3, 5 Not applicable, 1 Early Phase 1.
Follow Congenital Hyperinsulinism: new trials by email Literature Review of Congenital Hyperinsulinism trials Research Report on Congenital Hyperinsulinism
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Umbilical Cord Glucose For the screening, the interventions will be glucose measurements (and possibly G-BOBH), while follow-up assessments will include Bayley testing, EEG, and MRI. - Congenital Hyperinsulinism (CHI) | Not applicable | Not yet recruiting | Odense University Hospital | 50 | 2026-09-01 | 2026-08-31 |
| Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders Continuous glucose monitor with threshold and predictive alerts (Dexcom G7), Continuous glucose monitor with threshold-only alerts (Dexcom ONE+) - Glycogen Storage Disease, Congenital Hyperinsulinism (CHI) | Not applicable | Completed | University Hospital Padova | 11 | 2025-01-08 | 2026-05-29 |
| RZ358 Treatment for Congenital Hyperinsulinism RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC, RZ358 (10 mg/kg) or Placebo + SOC, RZ358 (5-10 mg/kg) + SOC - Congenital Hyperinsulinism | Phase 3 | Active not recruiting | Rezolute | 56 | 2024-01-11 | 2026-01-08 |
| Baby Detect : Genomic Newborn Screening Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1 | Completed | Centre Hospitalier Universitaire de Liege | 6824 | 2022-09-01 | 2025-08-12 | |
| HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI) HM15136 - Congenital Hyperinsulinism | Phase 2 | Active not recruiting | Hanmi Pharmaceutical Company Limited | 17 | 2022-05-05 | 2026-08-26 |
| Treatment of Post-bariatric Hypoglycaemia Dasiglucagon, HyoPen, Placebo - Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia | Phase 2 | Completed | Filip Krag Knop | 24 | 2021-08-20 | 2023-02-02 |
| 18F-DOPA II - PET Imaging Optimization 18F-DOPA, Furosemide Injection - Congenital Hyperinsulinism, Neuroblastoma | Phase 3 | Recruiting | University of Alberta | 800 | 2021-01-20 | 2026-02-09 |
| Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism dasiglucagon, Placebo - Congenital Hyperinsulinism | Phase 2 / Phase 3 | Completed | Zealand Pharma | 12 | 2020-06-19 | 2025-03-14 |
| An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, RZ358 Sequential Group Cohort 3 - Congenital Hyperinsulinism | Phase 2 | Completed | Rezolute | 23 | 2020-02-24 | 2025-05-28 |
| Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass ZP4207, Placebo (saline) - Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia | Phase 2 | Completed | University Hospital, Gentofte, Copenhagen | 10 | 2019-09-18 | 2020-03-31 |
| Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery Glucagon RTU, Placebo - Hyperinsulinemic Hypoglycemia | Phase 2 | Completed | Xeris Pharmaceuticals | 14 | 2019-05-10 | 2020-05-21 |
| Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism dasiglucagon - Congenital Hyperinsulinism | Phase 3 | Completed | Zealand Pharma | 42 | 2019-05-02 | 2026-08-03 |
| Application of Raw Corn Starch on Patients With Insulinoma low GI diet with regular supplementation of raw corn starch - Hyperinsulinemic Hypoglycemia, Insulinoma | Not applicable | Unknown | Peking Union Medical College Hospital | 20 | 2019-04-15 | 2019-04-29 |
| A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism Dasiglucagon, Standard of Care - Congenital Hyperinsulinism | Phase 3 | Completed | Zealand Pharma | 32 | 2019-02-07 | 2023-12-13 |
| Early Check: Expanded Screening in Newborns Confirmatory Testing - Spinal Muscular Atrophy, Fragile X Syndrome | Active not recruiting | RTI International | 30000 | 2018-10-15 | 2026-07-01 | |
| GLP-1 Receptor Expression in CHI 68Ga-exendin-4 PET/CT - Congenital Hyperinsulinism | Unknown | Radboud University Medical Center | 40 | 2018-02-07 | 2018-12-07 | |
| 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety 18F-DOPA - Congenital Hyperinsulinism, Neuroblastoma | Phase 3 | Completed | University of Alberta | 400 | 2017-06-29 | 2022-01-10 |
| Pasireotide in Hyperinsulinemic Hypoglycemia Pasireotide 0.6Mg Solution for Injection, Saline Solution - Congenital Hyperinsulinism, Insulinoma | Phase 2 | Withdrawn | Montefiore Medical Center | 2017-04-01 | 2021-05-14 | |
| Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia Pasireotide - Hyperinsulinemic Hypoglycemia, Post Gastrointestinal Tract Surgery Hypoglycaemia | Phase 1 | Completed | University of Colorado, Denver | 1 | 2017-03-22 | 2021-09-29 |
| 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism 18F-Fluoro Dopa Imaging - Congenital Hyperinsulinism | Phase 2 | Recruiting | Miguel Pampaloni | 50 | 2016-11-03 | 2026-05-01 |
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Hypoglycemia (15) · Hyperinsulinism (12) · Insulinoma (5) · Glucose Metabolism Disorders (3) · Metabolic Diseases (3) · Pancreatic Diseases (3) · 3-Hydroxy-3-Methylglutaryl-CoA Lyase Deficiency (2) · Acidemia, isovaleric (2) · Anemia, Sickle Cell (2) · Argininosuccinic Aciduria (2) · Ataxia with vitamin E deficiency (2) · Basal ganglia disease, biotin-responsive (2) · Beta ketothiolase deficiency (2) · Biotinidase Deficiency (2)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (38) · Nutritional and Metabolic Diseases (38) · Infant, Newborn, Diseases (37) · Digestive System Diseases (36) · Glucose Metabolism Disorders (35) · Metabolic Diseases (35) · Pancreatic Diseases (35) · Hyperinsulinism (26) · Hypoglycemia (23) · Neoplasms (9) · Neoplasms by Histologic Type (9) · Neoplasms, Glandular and Epithelial (9) · Neoplasms by Site (8) · Endocrine System Diseases (7) · Endocrine Gland Neoplasms (6)
fluorodopa F 18 (7) · dasiglucagon (5) · exendin (9-39) (4) · pasireotide (3) · Glucagon (2) · Saline Solution (2) · Standard of Care (2) · 4-chloro-N-(2-furylmethyl)-5-sulfamoylanthranilic acid (1) · 68Ga-NOTA-exendin-4 (1) · Acarbose (1) · Carbohydrates (1) · Electroencephalography (1) · Exenatide (1) · Furosemide (1) · HM15136 (1)
Children's Hospital of Philadelphia (3) · Diva De Leon (3) · Zealand Pharma (3) · Montefiore Medical Center (2) · Peking Union Medical College Hospital (2) · Rezolute (2) · University of Alberta (2) · University of Minnesota (2) · Xeris Pharmaceuticals (2) · Assistance Publique - Hôpitaux de Paris (1) · Baylor College of Medicine (1) · Centre Hospitalier Universitaire de Liege (1) · Cook Children's Health Care System (1) · Filip Krag Knop (1) · Hanmi Pharmaceutical Company Limited (1)
United States (24) · United Kingdom (7) · Germany (6) · Israel (6) · Denmark (4) · Canada (3) · Bulgaria (2) · China (2) · France (2) · Georgia (2) · Netherlands (2) · Spain (2) · Turkey (Türkiye) (2) · Belgium (1) · Greece (1)
Lisa J States, MD (2) · Allan Gordon, MD, PhD (1) · Charlotte Teglman Schioeler (1) · Curt Scharfe, MD, PhD (1) · Dalit Modan, M.D. (1) · Diva D De Leon, MD (1) · Diva D De Leon, MD MSCE (1) · Diva D DeLeon, MD (1) · Erika Brutsaert, M.D., M.P.H. (1) · Fang Li, MD (1) · Filip K Knop, MD, PhD (1) · Filip M. Knop, Prof., MD (1) · Gopal Saha, MD (1) · Helen Lawler, MD (1)
PMID 17236890, PMID 17895314, PMID 21697252, PMID 22855730, PMID 23414871, PMID 24314195, PMID 24314196, PMID 26037514, PMID 31315600, PMID 35142618, PMID 35320361, PMID 35416981, PMID 40107271
2017 (1), 2019 (1), R03DK078535 (1), R44DK105691 (1), ZIAEB000073 (1)