A Phase 1 interventional study of Exendin (9-39) in Hyperinsulinemia Hypoglycemia, sponsored by Tracey McLaughlin. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Tracey McLaughlin · Phase 1, Interventional, and Treatment
Among 24 studies in Congenital Hyperinsulinism with a site in United States — 3 open to participants now, 6 under way, 1 of them phase 3. Congenital Hyperinsulinism · United States.
Among the 24 studies in Congenital Hyperinsulinism with a site in United States, this one is the 17th largest by enrollment of the 20 interventional ones, is one of 2 that started in 2015, is one of 4 in phase 1, and was the 14th registered.
38 studies on the registry are indexed under Congenital Hyperinsulinism; 6 are open to participants now.
This study's enrollment of 9 is below the median of 17 across 30 interventional studies indexed under Congenital Hyperinsulinism.
Browse Congenital Hyperinsulinism studies →3 of the 24 studies in Congenital Hyperinsulinism with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 4 Congenital Hyperinsulinism studies recruiting now, 2 (50%) set no upper age limit and 2 (50%) stop at 75 or younger; 3 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2015.
Median enrollment 16 across the 20 interventional studies, 30,000 across the 1 observational. Of the 16 that completed or were terminated, 9 (56%) have results posted.
7 of 24 have an industry lead sponsor. The 10 most frequent:
Tracey McLaughlin is the lead sponsor of 3 studies on the registry; none are open to participants now.
Tracey McLaughlin has 1 study filed under Congenital Hyperinsulinism — fewer than ten, so there is no comparison to draw.
2 of the studies in Congenital Hyperinsulinism with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
| NCT04205604Miguel Pampaloni18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism | 2026-12-01 |
Among the 24 studies in Congenital Hyperinsulinism with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with post-bariatric hypoglycemia.
Post-Bariatric Hypoglycemia (PBH) is a debilitating rare disease afflicting 0.2-6.9% of post-bariatric patients, characterized by repeated severe hypoglycemic episodes with neuroglycopenic symptoms and marked disability. There are no effective medical therapies.
While the cause is not known, exaggerated postprandial secretion of glucagon-like peptide-1 (GLP-1) as a result of altered nutrient transit likely plays a major role. GLP-1 is an incretin hormone secreted primarily by the distal ileum that contributes to postprandial glucose regulation. Exendin 9-39 (Ex9) is a specific GLP-1 receptor antagonist, that when given via continuous IV infusion, has been shown to effectively prevent postprandial hypoglycemia in patients with PBH. Subcutaneous (SC) injection of Ex9 may represent a safe, effective and practical therapeutic approach to treating PBH.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous injection of Dose A of Exendin (9-39)
Drug: Exendin (9-39)
Subcutaneous injection of Dose B of Exendin (9-39)
Drug: Exendin (9-39)
Subcutaneous injection of Dose C of Exendin (9-39)
Drug: Exendin (9-39)
Subcutaneous injection of Dose D of Exendin (9-39)
Drug: Exendin (9-39)
Treatment effect on plasma glucose
Magnitude of plasma glucose nadir during repeat OGTT after treatment
Time frame: 0-180 minutes following initiation of oral glucose tolerance test (OGTT) conducted after treatment.
Treatment effect on symptoms of hypoglycemia
Response rate in symptom score during repeat OGTT after treatment.
Time frame: 0-180 minutes following initiation of OGTT
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2015 to primary completion in Aug 2016, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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