NCT04459338

A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion

Completed Phase 3 Results posted Last updated 9 June 2023

What this trial tests

Phase 3 trial testing Exendin-9,39 in Healthy in 11 participants. Completed in 14 June 2022.

Timeline

4 March 2021

Primary endpoint
14 June 2022

14 June 2022

Quick facts

Lead sponsor	Adrian Vella
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	11
Start date	4 March 2021
Primary completion	14 June 2022
Estimated completion	14 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Exendin-9,39
• Saline

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Adrian Vella — full company profile →

Who can join

Adults 25 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Insulin Secretion Rate During Exendin-9,39 Infusion vs. Insulin Secretion Rate During Saline Infusion Primary · Area under the curve was quantified at the end of the Saline Study and at the end of the Exendin-9,39 study

This is the area under the curve for insulin secretion over the duration of the hyperglycemic clamp (0 to 300 minutes during the study in the Clinical Research Unit).

Group	Value	95% CI
Insulin Secretion During the Saline Study	191	± 23
Insulin Secretion During the Exendin-9,39 Study	171	± 19

Adverse events — posted to ClinicalTrials.gov

Time frame: Time between screening and completion of the study = 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Saline

Serious: 0/11 (0%)

Deaths: 0/11

Exendin-9,39

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (2 terms — click to expand)

Reaction	System	Saline	Exendin-9,39
Infusion line lost	Skin and subcutaneous tissue disorders	—	—
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04459338 adverse events section.

Sponsor's own description

The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study is to evaluate the role of GLP1R in the response to elevated glucagon concentrations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effect of Glucagon-Like Peptide 1 Receptor Blockade on Glucagon-Induced Stimulation of Insulin Secretion.
   Farahani RA, Egan AM, Welch AA, Laurenti MC, et al · · 2023 · cited 9× · PMID 36562995 · DOI 10.2337/db22-0709