GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

A Randomized, Phase 1, Three-Period, Placebo- and Positive-Controlled, Double-Blind, Crossover Study to Assess the Electrophysiological Effects of Exenatide at Therapeutic and Supratherapeutic Concentrations on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

Lead sponsor

AstraZeneca

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 25-35•Healthy volunteers

Primary endpoints

•Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based•Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide

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 IDNCT01297062

Org study IDBCB112

Timeline

Milestones

Study first posted2011-02-16estimated

Results first posted2012-05-31estimated

Last update posted2015-04-14estimated

Study start2011-02 (month precision)

Primary completion2011-04actual (month precision)

Study completion2011-05actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Is overtly healthy, as determined by medical history and physical examination

•Has body mass index (BMI) between 25 and 35 kg/m2

•Has fasting serum glucose <110 mg/dL

•Has no clinically significant blood pressure or heart rate readings as judged by the investigator at study start

•Has electrocardiogram (ECG) results judged as not clinically significant by the investigator at study start

Exclusion criteria

•Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being

•Has an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as a Bazett's corrected QT (QTcB) interval >450 ms.

•Family history of sudden death

•Personal history of unexplained syncope within last year, or family history of Long QT Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months

Endpoints (9)

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.

Safety / tolerability / PK

9 endpoints

Primary/protocol endpoint

Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL)

Time frame:Baseline, Day 1

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), msec	95% CI
Exenatide	-2.25	-3.30 – -1.20
Placebo	-0.89	-1.88 – 0.10

Least Squares Mean Difference-1.3690% CI-2.21 – -0.50Mixed Models Analysis

Primary/protocol endpoint

Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL)

Time frame:Baseline, Day 2

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), msec	95% CI
Exenatide	-2.58	-3.64 – -1.52
Placebo	-0.56	-1.54 – 0.43

Least Squares Mean Difference-2.0290% CI-2.88 – -1.16Mixed Models Analysis

Primary/protocol endpoint

Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL)

Time frame:Baseline, Day 3

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), msec	95% CI
Exenatide	-3.54	-4.66 – -2.42
Placebo	-2.41	-3.44 – -1.38

Least Squares Mean Difference-1.1390% CI-2.11 – -0.15Mixed Models Analysis

Secondary/protocol endpoint

Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2

Time frame:Baseline, Day 2

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), msec	95% CI
Moxifloxacin	1.91	0.12 – 3.70
Placebo	-3.56	-5.14 – -1.98

Least Squares Mean Difference5.4790% CI2.82 – 8.12Mixed Models Analysis

Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.

Secondary/protocol endpoint

Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2

Time frame:Baseline, Day 2

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), msec	95% CI
Moxifloxacin	9.75	8.20 – 11.30
Placebo	-0.81	-2.26 – 0.63

Least Squares Mean Difference10.5690% CI8.46 – 12.67Mixed Models Analysis

Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.

Secondary/protocol endpoint

Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2

Time frame:Baseline, Day 2

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), msec	95% CI
Moxifloxacin	12.47	10.79 – 14.15
Placebo	1.56	0.18 – 2.93

Least Squares Mean Difference10.9290% CI8.71 – 13.13Mixed Models Analysis

Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.

Secondary/protocol endpoint

Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo

Time frame:Day 1, 2, or 3

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
Exenatide	0	—
Placebo	0	—

Secondary/protocol endpoint

Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo

Time frame:Baseline, Day 1, 2, or 3

threshold achievement, event

Posted result

Group	Value (number), particpants	95% CI
Exenatide	0	—
Placebo	0	—

Secondary/protocol endpoint

Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3

Time frame:Baseline, Day 1, 2, and 3

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg/mL	95% CI
ExenatideDay 1	252.74	—
Day 2	399.14	—
Day 3	626.65	—

Slope0.000890% CI-0.0017 – 0.0033p0.5962Mixed Models Analysis

The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.

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.