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TerminatedPhase 1Results posted

Pharmacogenomics of GLP1 Receptor Agonists

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

63

actual

Study population

Healthy volunteers

Key I/E criterion

BMI 18-40

Primary endpoints

Exenatide Effect on First Phase Insulin SecretionExenatide Effect on Glucose Disappearance Rate

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05762744
Org study IDHP-00067574

Timeline

Milestones

Study start2016-06-01actual
Primary completion2018-11-30actual
Study completion2022-10-31actual
Study first posted2023-03-10actual
Last update posted2025-07-01actual
Results first posted2025-07-01actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Member of the Old Order Amish community in Lancaster County, Pennsylvania
BMI: 18-40 kg/sq.m.

Exclusion criteria

Known allergy to exenatide
History of diabetes, random glucose >200 mg/dL, or HbA1c > 6.5%
Significant debilitating chronic cardiac, hepatic, pulmonary, or renal disease or other diseases that the investigator judges will make interpretation of the results difficult or increase the risk of participation
Seizure disorder
Pregnant by self-report or known pregnancy within 3 months of the start of study
Currently breast feeding or breast feeding within 3 months of the start of the study
Estimated glomerular filtration rate <60 mL/min/1.73m2
Hematocrit <35%
Liver function tests greater than 2 times the upper limit of normal
Abnormal thyroid stimulating hormone
History of pancreatitis or pancreatic cancer. Personal or family history of medullary carcinoma of the thyroid.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

16 endpoints
Primary/registry result

Exenatide Effect on First Phase Insulin Secretion

Time frame:0-10 minutes

descriptive

Posted result

GroupValue (mean), Ratio (no units)95% CI
Exenatide First Followed by Saline1.90
Saline First Followed by Exenatide2.18
p0.37t-test, 2 sided

Null hypothesis: the order of FSIGTs (saline or exenatide-stimulated) does not affect the response during an FSIGT

Primary/registry result

Exenatide Effect on Glucose Disappearance Rate

Time frame:25-50 minutes

descriptive

Posted result

GroupValue (mean), Ratio (no units)95% CI
Exenatide First Followed by Saline2.16
Saline First Followed by Exenatide2.28
p0.66t-test, 2 sided

Null hypothesis: The order of FSIGT (exenatide-stimulated or saline) does not affect the response to an FSIGT.

Primary/protocol endpoint

Exenatide Effect on First Phase Insulin Secretion

Time frame:0-10 minutes

ratio, improvement

Primary/protocol endpoint/low confidence

Exenatide Effect on Glucose Disappearance Rate

Time frame:25-50 minutes

ratio, improvement

Secondary/registry result

Glucose Disappearance Rate (Exenatide)

Time frame:25-50 minutes

descriptive

Posted result

GroupValue (mean), Log(mg/dL) per min95% CI
Exenatide First Followed by Saline1056
Saline First Followed by Exenatide1131
p0.55t-test, 2 sided

Null hypothesis: the order of testing (exenatide-stimulated or saline FSIGT) does not affect data obtained in the FSIGTs.

Secondary/registry result

Glucose Disappearance Rate (Placebo)

Time frame:25-50 minutes

descriptive

Posted result

GroupValue (mean), Log(mg/dL) per min95% CI
Exenatide First Followed by Saline500
Saline First Followed by Exenatide547
p0.45t-test, 2 sided

The order of FSIGTs (exenatide-stimulated or saline) does not affect the response during an FSIGT

Secondary/registry result

First Phase Insulin Secretion (Exenatide)

Time frame:0-10 minutes

descriptive

Posted result

GroupValue (mean), microunits/mL*min95% CI
Exenatide First Followed by Saline561
Saline Followed by Exenatide494
p0.86t-test, 2 sided

Null hypothesis: the order of FSIGT (exenatide or saline) does not affect the response during an FSIGT

Secondary/registry result

First Phase Insulin Secretion (Placebo)

Time frame:0-10 minutes

descriptive

Posted result

GroupValue (mean), microunits/mL*min95% CI
Exenatide First Followed by Normal Saline305
Placebo First Followed by Exenatide254
p0.44t-test, 2 sided

Null hypothesis: The order of FSIGTs (exenatide-stimulated or saline) does not affect the response to an FSIGT

Secondary/registry result

Drug Effect on First-Phase Insulin Secretion (Genotype-specific)

Time frame:0 - 10 min during the FSIGT

descriptive

Posted result

GroupValue (mean), Ratio: no units95% CI
Major Allele Homozygotes2.25
Homozygotes for the p.G40S Allele of GCGR1.94
Homozygotes for the p.E354Q Allele of GIPR1.87
p0.41t-test, 2 sided

Null hypothesis: no differences between the two groups with respect to exenatide's effect on first-phase insulin secretion. t-test conducted on logarithms of the values

p0.38t-test, 2 sided

Null hypothesis: no difference between two groups with respect to exenatide's effect on first phase insulin secretion

Secondary/registry result

Exenatide's Effect on the Rate of Glucose-disappearance (Genotype Specific)

Time frame:25-50 min during the FSIGT

descriptive

Posted result

GroupValue (mean), Log(mg/dL) per min95% CI
Major Allele Homozygotes2.19
Homozygotes for the p.G40S Allele of GCGR2.28
Homozygotes for the p.E354Q Allele of GIPR2.18
p0.80t-test, 2 sided

Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance

p0.98t-test, 2 sided

Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance during an FSIGT

Secondary/protocol endpoint/low confidence

Glucose Disappearance Rate (Exenatide)

Time frame:25-50 minutes

descriptive

Secondary/protocol endpoint/low confidence

Glucose Disappearance Rate (Placebo)

Time frame:25-50 minutes

descriptive

Secondary/protocol endpoint/low confidence

First Phase Insulin Secretion (Exenatide)

Time frame:0-10 minutes

concentration, descriptive

Secondary/protocol endpoint

First Phase Insulin Secretion (Placebo)

Time frame:0-10 minutes

concentration, descriptive

Secondary/protocol endpoint

Drug Effect on First-Phase Insulin Secretion (Genotype-specific)

Time frame:0 - 10 min during the FSIGT

ratio, improvement

Secondary/protocol endpoint/low confidence

Exenatide's Effect on the Rate of Glucose-disappearance (Genotype Specific)

Time frame:25-50 min during the FSIGT

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.