GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

A Placebo- and Positive-Controlled Study of the Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 19-35•Healthy volunteers

Primary endpoint

•Comparison of exenatide's effect on QT interval when

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 IDNCT00672399

Org study IDH8O-EW-GWCI

Timeline

Milestones

Study first posted2008-05-06estimated

Last update posted2015-02-24estimated

Study start2008-04 (month precision)

Primary completion2008-07actual (month precision)

Study completion2008-07actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Are between the ages of 18 and 65 years, inclusive.

•Have body mass index (BMI) between 19 and 35 kg/m2, inclusive.

•If females, are not of child-bearing potential due to surgical sterilisation (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they have had cessation of menses for at least 1 year or 6 to 12 months of spontaneous amenorrhea with follicle stimulating hormone >40 IU/mL; age ≥45 years; not taking oral contraceptives for at least 1 year; and otherwise healthy.

•Subjects receiving hormone replacement therapy (HRT) or thyroxine as replacement therapy may participate providing they have been on stable therapy for at least 3 months and have a normal thyroid stimulating hormone (TSH) value.

Exclusion criteria

•Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

•Known allergies to exenatide or excipients, moxifloxacin or related compounds, or a history of multiple adverse drug allergies of any origin.

•Family history of sudden death.

•Personal history of unexplained syncope within last year.

•History or presence of cardiovascular (myocardial infarction, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, GI, endocrine, haematological, or neurological disorders.

•Evidence or history of Long QT Syndrome or significant active cardiac disease (e.g., arrhythmia, hypertension, congestive heart failure, hypokalaemia, mitral valve regurgitation, endocarditis, coronary artery heart disease), or symptoms of angina pectoris or transient ischaemic attacks within the previous 6 months.

•Females who are lactating.

•Have previously completed or withdrawn from this study or any other study investigating exenatide.

•Evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.

•Evidence of hepatitis C and/or positive hepatitis C antibody.

•Evidence of hepatitis B and/or positive hepatitis B surface antigen.

•Use of over-the-counter or prescription medication (other than, for example, thyroid replacement, occasional intake of paracetamol, or vitamin or mineral supplements) 7 and 14 days, respectively, before dosing and throughout the study.

•Cumulative blood donation of more than 500 mL within the last 3 months.

•Subjects who have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or subjects unwilling to stop alcohol consumption for the duration of the study(1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).

•Subjects who smoke or have smoked within 28 days of their screening visit and who are unable to abide by the study restrictions.

Endpoints (3)

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

3 endpoints

Primary/protocol endpoint

Comparison of exenatide's effect on QT interval when compared to placebo

Time frame:single doses - measurements at 1, 2, 3, 4, 5.5 and 10 hours after dosing

change from baseline, improvement

Secondary/protocol endpoint

Measurement of any QTcF changes following exenatide versus glucose, potassium, and insulin

Time frame:single doses - samples drawn at and EKGs at -15 min, hours 1, 2, 3, 4, 5.5, 10

change from baseline, descriptive

Secondary/protocol endpoint

Assessment of plasma exenatide concentrations and QTc interval

Time frame:During Periods I, II, and III, ECGs should be recorded at the following

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.