Phase 3 · Liraglutide

NCT04466566 trial results

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

Participants
21
Status
completed
Completed
2025-12-30
Sponsor
Adrian Vella

As posted on ClinicalTrials.gov (NCT04466566), updated at source Oct 28, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT04466566 measured first

Average Insulin Secretion in Response to HyperglycemiaμIU/mL · insulin secretion rate at the end of the hyperglycemic clamp i.e.: 180 minutes · mean
MeasureSalinen=17Exendin-9, 39n=16Liraglutiden=16
AG Genotype17(2)13(1)154(12)
AA Genotype33(3)58(23)542(143)
GG Genotype23(3)16(2)184(17)
Side effects by arm

Side effects in NCT04466566

Percent of participants affected, Adverse events were collected from the time of informed consent through study completion, approximately 16 weeks.. The most common events the registry lists.

EventSalineExendin-9,39Liraglutide
Any serious event0%0%5.9%
Hypoglycemia0%5.9%17.6%
Nausea/Vomiting11.8%5.9%11.8%
Flushed/Hot/Diaphoretic5.9%5.9%11.8%
Headache11.8%0%5.9%
Asymptomatic hypoglycemia0%0%5.9%
Lightheaded/Shaky/Pale/Sweaty5.9%0%0%
Hypotension0%5.9%0%
Secondary outcomes

What else it measured

Change in Glucagon Secretion Rate Measured by Immunoassaypmol/min · 0 Minutes, 180 Minutes · mean
MeasureSalinen=17Exendin-9,39n=16Liraglutiden=16
AG Genotype 0 Minutes20.6(5.5)22.8(4.6)22.1(3.4)
AA Genotype 0 Minutes36.4(7.9)57.7(15.3)46.0(6.4)
GG Genotype 0 Minutes18.7(1.3)19.3(2.5)17.2(1.9)
AG Genotype 180 Minutes5.8(0.1)6.4(0.6)6.3(0.1)
AA Genotype 180 Minutes6.6(0.1)6.5(0.1)6.3(0.1)
GG Genotype 180 Minutes6.1(0.1)6.0(0.1)6.0(0.2)
The trial

How NCT04466566 was run

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.

  • Saline: Saline will be infused during the study
  • Exendin-9,39: Exendin-9,39 will be infused during the study
  • Liraglutide: Liraglutide will be infused during the study
Who could join the trial

Inclusion Criteria: * 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. Exclusion Criteria: * Individuals under 18 and over 65 years of age.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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