HealthyPhase 3NCT04466566

A Study to Evaluate the Effect of Genetic Variation on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetics

A Phase 3 study testing Saline, Exendin-9,39 and Liraglutide in people with Healthy, run by Adrian Vella at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Saline, Exendin-9,39 and Liraglutide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 17 Oct 2022to 30 Dec 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

40 nondiabetic subjects will be recruited.
20 subjects with the AA or AG genotype at rs3765467 and remainder will have the GG genotype.
Individuals encompassing the age span of 18-65 years.

Who cannot join

Individuals under 18 and over 65 years of age.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Effect of Genetic Variation in the GLP-1 Receptor on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetic Humans

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 to find out how genetic variations in GLP1R alter insulin secretion, in the fasting state and when blood sugars levels are elevated.

Conditions: Healthy
Being tested: Saline, Exendin-9,39, Liraglutide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SalineOther
Saline will serve as the control
Exendin-9,39Biological
Exendin-9,39 will block the GLP-1 receptor
LiraglutideBiological
Liraglutide will serve as the GLP-1 receptor agonist/stimulator

Study groups in NCT04466566
Study group	Role	What they receive
Saline	Placebo comparator	Saline will be infused during the study Receives: Other: Saline
Exendin-9,39	Active comparator	Exendin-9,39 will be infused during the study Receives: Biological: Exendin-9,39
Liraglutide	Active comparator	Liraglutide will be infused during the study Receives: Biological: Liraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Insulin Secretion in Response to Hyperglycemia
Insulin secretion was estimated from C-peptide concentrations using the deconvolution method which incorporates c-peptide kinetics, and the subject's age, body surface area, body mass index, and diabetes status. A hyperglycemic clamp will be used which allows the glucose to be maintained at 160mg/dL (9mmol/L). C-peptide concentrations were drawn every 10 minutes from -30 minutes to 180 minutes, and the insulin secretion at 180 minutes was reported.
Measured: insulin secretion rate at the end of the hyperglycemic clamp i.e.: 180 minutes

Secondary outcomes (1)

Change in Glucagon Secretion Rate Measured by Immunoassay
The Glucagon secretion rate during fasting (0 minutes) and at the end of the hyperglycemic clamp (180 minutes).
Measured: 0 Minutes, 180 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 202230 Dec 2025

First posted10 Jul 2020
Study start17 Oct 2022
Primary completion30 Sep 2025
Study completion30 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04466566
Sponsor's protocol ID: 20-003984
Other IDs: R01DK126206
Status last verified: Oct 2026
First submitted: 30 Jun 2020
Last updated: 28 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Genetic Variation in the GLP-1 Receptor on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetic Humans
ClinicalTrials.gov ID: NCT04466566
Acronym / sponsor ID: 20-003984
Conditions: Healthy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Adrian VellaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 17 Oct 2022 (actual)
Primary completion: 30 Sep 2025 (actual)
Study completion: 30 Dec 2025 (actual)
First posted: 10 Jul 2020 (actual)
Results: Posted 28 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Saline	Placebo comparator	Other: SalineSaline will be infused during the study
Exendin-9,39	Active comparator	Biological: Exendin-9,39Exendin-9,39 will be infused during the study
Liraglutide	Active comparator	Biological: LiraglutideLiraglutide will be infused during the study

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

40 nondiabetic subjects will be recruited.
20 subjects with the AA or AG genotype at rs3765467 and remainder will have the GG genotype.
Individuals encompassing the age span of 18-65 years.

Key exclusion criteria (1 listed)

Individuals under 18 and over 65 years of age.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SalineSaline will serve as the control	Other	Saline
Exendin-9,39Exendin-9,39 will block the GLP-1 receptor	Biological	Exendin-9,39
LiraglutideLiraglutide will serve as the GLP-1 receptor agonist/stimulator	Biological	Liraglutide

Primary outcome

Average Insulin Secretion in Response to Hyperglycemia
Time frame: insulin secretion rate at the end of the hyperglycemic clamp i.e.: 180 minutes
Insulin secretion was estimated from C-peptide concentrations using the deconvolution method which incorporates c-peptide kinetics, and the subject's age, body surface area, body mass index, and diabetes status. A hyperglycemic clamp will be used which allows the glucose to be maintained at 160mg/dL (9mmol/L). C-peptide concentrations were drawn every 10 minutes from -30 minutes to 180 minutes, and the insulin secretion at 180 minutes was reported.

1 secondary outcome

Change in Glucagon Secretion Rate Measured by Immunoassay
Time frame: 0 Minutes, 180 Minutes

Results and safety

Results posted to the registry on 28 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saline Exendin Victoza	7	6
Saline Victoza Exendin	2	1
Exendin Saline Victoza	6	6
Exendin Victoza Saline	1	1
Victoza Saline Exendin	1	0
Victoza Exendin Saline	3	2

Primary outcome: Average Insulin Secretion in Response to Hyperglycemia

Time frame: insulin secretion rate at the end of the hyperglycemic clamp i.e.: 180 minutes. Mean (Standard Error). Unit: μIU/mL

Measure	Saline n = 17	Exendin-9, 39 n = 16	Liraglutide n = 16
AG Genotype	17 (2)	13 (1)	154 (12)
AA Genotype	33 (3)	58 (23)	542 (143)
GG Genotype	23 (3)	16 (2)	184 (17)

Population analysed: Subjects were further broken down into the following categories based on genotype: AG Genotype, AA Genotype and GG Genotype. In the Saline arm, 6 subjects were AG genotype, 2 were AA genotype and 9 were GG genotype. In the Exendin-9, 39 arm, 6 were AG Genotype, 2 were AA Genotype and 8 were GG genotype. In the Liraglutide arm, 5 were AG genotype, 2 were AA genotype and 9 were GG genotype.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent through study completion, approximately 16 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saline	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17
Exendin-9,39	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17
Liraglutide	1 of 17 (5.9%)	7 of 17 (41.2%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adrian Vella, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saline, Exendin-9,39 and Liraglutide in people with Healthy, run by Adrian Vella at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Insulin Secretion in Response to Hyperglycemia (time frame: insulin secretion rate at the end of the hyperglycemic clamp i.e.: 180 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04466566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.