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GLP-1 Receptor Antagonist

Exendin-9,39 for High Blood Sugar in Healthy Subjects

Phase 3
Recruiting
Led By Adrian Vella, MD
Research Sponsored by Adrian Vella
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals encompassing the age span of 25-65 years.
40 nondiabetic subjects will be recruited.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be averaged over the 0-180 minute data of the study
Awards & highlights

Study Summary

This trial is investigating how different versions of the GLP1R gene affect insulin secretion in people with and without diabetes.

Who is the study for?
This trial is for nondiabetic individuals aged 25-65. It's specifically looking at how genetic differences in a gene called GLP1R affect insulin secretion when fasting and during high blood sugar levels. Participants will be split into two groups based on their genetics: one with the AA genotype and another with the GG genotype at rs3765467.Check my eligibility
What is being tested?
The study tests the effects of saline (a placebo) and Exendin-9,39 (which affects insulin secretion) on beta-cell function in healthy subjects. The goal is to understand how variations in the GLP1R gene influence this process under different blood sugar conditions.See study design
What are the potential side effects?
Since Exendin-9,39 can impact insulin release, potential side effects may include changes in blood sugar levels that could lead to symptoms like dizziness or shakiness due to low blood sugar, or thirst and frequent urination if blood sugar goes too high.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 65 years old.
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I am not diabetic.
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My genetic test shows I have either the AA or GG genotype at rs3765467.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this will be averaged over the 0-180 minute data of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be averaged over the 0-180 minute data of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insulin secretion quantified using the minimal model to generate an index of beta-cell responsivity (Φ)
Secondary outcome measures
Glucagon secretion measured by immunoassay

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Exendin-9,39Active Control1 Intervention
Exendin-9,39 will be infused during the study
Group II: SalinePlacebo Group1 Intervention
Saline will be infused during the study

Find a Location

Who is running the clinical trial?

Adrian VellaLead Sponsor
8 Previous Clinical Trials
169 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,368 Total Patients Enrolled
Adrian Vella, MDPrincipal InvestigatorMayo Clinic
14 Previous Clinical Trials
469 Total Patients Enrolled

Media Library

Exendin-9,39 (GLP-1 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04466566 — Phase 3
Healthy Subjects Research Study Groups: Saline, Exendin-9,39
Healthy Subjects Clinical Trial 2023: Exendin-9,39 Highlights & Side Effects. Trial Name: NCT04466566 — Phase 3
Exendin-9,39 (GLP-1 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04466566 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present regulatory status of Exendin-9,39?

"Exendin-9,39's Phase 3 status indicates that, while more safety data is needed, there is enough efficacy data and supporting safety data to warrant a score of 3."

Answered by AI

Does this particular research project allow senior citizens to enroll?

"In order for an individual to participate in this clinical trial, they must be aged 25-65. There are currently 57 trials underway for patients younger than 18 and 446 for those older than 65."

Answered by AI

Could I take part in this clinical trial if I take this medication?

"This study requires 40 test subjects that are between 25 and 65 years old and considered to be healthy. Out of the 40 subjects, 20 must have the AA genotype at rs3765467, while the other 20 can have any genotype."

Answered by AI

Are there any patients that this research project is looking for right now?

"According to the latest update on clinicaltrials.gov, this study is not presently looking for patients. The trial was initially posted on 10/1/2022 and was last edited on 7/28/2022. However, there are 951 other trials that are presently searching for participants."

Answered by AI
~10 spots leftby Oct 2024