DelfaGLP-1 Atlas

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EMPRES

UnknownPhase 2

Exenatide for Myocardial Protection During Reperfusion Study

Exenatide for Myocardial Protection During Reperfusion Study: A Double-blind, Placebo-controlled Trial

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

10

Recruiting sites

10

Enrollment

198

estimated

Study population

Cardiovascular disease

Key I/E criterion

—

Primary endpoint

•Ratio of final infarct size

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 IDNCT01938235
Org study IDMB001-001
Secondary ID9427-D0416-21CHealth Canada

Timeline

Milestones

Study first posted2013-09-10estimated
Last update posted2016-08-05estimated
Study start2014-02 (month precision)
Primary completion2017-07estimated (month precision)
Study completion2018-01estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Cardiovascular disease

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Admission for primary PCI for STEMI, with enrollment within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥1mm in 2 or more limb leads, or ≥2mm in 2 or more precordial leads, or new onset LBBB) associated with acute chest pain or an elevation of cardiac enzymes.
•Antegrade TIMI 0 or 1 prior to PCI in the infarct-related artery
•Age ≥18 years

Exclusion criteria

•Symptomatic hypoglycemia (serum glucose <3.3 µmol/L; 60 mg/dl)
•Diabetes mellitus requiring insulin therapy
•Diabetic ketoacidosis
•Coronary anatomy warranting emergent coronary artery bypass graft surgery
•Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation)
•Need for hemodialysis
•Malignancy, HIV, or central nervous system disorder
•Cardiopulmonary resuscitation >15 min and compromised level of consciousness.
•Cardiogenic shock
•Current participation in any research study involving investigational drugs or devices
•Inability to give informed consent
•Inability to safely undergo cMRI (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant, severe claustrophobia)
•Women of childbearing potential who are known to be pregnant or lactating or who have a positive pregnancy test on admission
•History of pancreatitis
•Known end stage renal failure or known eGFR <30 mL/min
•Currently taking exenatide (Byetta, Bydureon), liraglutide (Victoza), or any other GLP-1 agonist

Endpoints (32)

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.

Coverage by outcome category

Cardiovascular outcomes
8
Other (unclassified)
6
Glycemic / diabetes
5
Heart failure
5
Other clinical outcomes
4
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2

Cardiovascular outcomes

8 endpoints
Secondary/protocol endpoint

Death

Time frame:3 months

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Myocardial infarction (heart attack)

Time frame:3 months

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization)

Time frame:6 months

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Myocardial infarction (any), Stroke (any), Coronary revascularization

Secondary/protocol endpoint

Death

Time frame:6 months

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Recurrent myocardial infarction (heart attack)

Time frame:6 months

Myocardial infarction (any)

event count, event

SNOMED 22298006

Secondary/protocol endpoint

Stroke

Time frame:6 months

Stroke (any)

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

Unplanned repeat revascularization

Time frame:6 months

Coronary revascularization

event count, event

SNOMED 415070008

Secondary/protocol endpoint/low confidence

Cardiogenic shock

Time frame:During index hospitalization (up to 6 months)

event count, event

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

Serum glucose concentration

Time frame:Baseline

descriptive, improvement

Secondary/protocol endpoint

Serum glucose concentration

Time frame:8 hours

descriptive, improvement

Secondary/protocol endpoint

Serum glucose concentration

Time frame:16 hours

descriptive

Secondary/protocol endpoint

Serum glucose concentration

Time frame:24 hours

descriptive, improvement

Secondary/protocol endpoint

Serum glucose concentration

Time frame:72 hours

concentration, descriptive

Heart failure

5 endpoints
Secondary/protocol endpoint

Left ventricular global and regional LV systolic ejection fraction

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint

NT-proBNP blood levels

Time frame:24 hours

NT-proBNP, change

change from baseline, improvement

Secondary/protocol endpoint

Measure of extent of heart failure (NYHA classification)

Time frame:72 hours

NYHA class, change

categorical status, improvement

Secondary/protocol endpoint

Measure of extent of heart failure (NYHA classification)

Time frame:3 months

NYHA class, change

change from baseline, improvement

Secondary/protocol endpoint

Development of heart failure

Time frame:6 months

time to event, event

SNOMED 84114007

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Myocardial enzyme levels (troponin I and CK-MB)

Time frame:24 hours

descriptive

Secondary/protocol endpoint/low confidence

Angiographic myocardial blush score

Time frame:At the time of the PCI procedure

descriptive

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Blood glucose < 3.0 mmol/L

Time frame:During index hospitalization (up to 6 months)

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Hypotension (defined as SBP <90 mmHg)

Time frame:During index hospitalization (up to 6 months)

threshold achievement, event

LOINC 8480-6

Other clinical outcomes

4 endpoints
Secondary/protocol endpoint

ST segment elevation resolution (measured by ECG)

Time frame:1 hour

categorical status, improvement

Secondary/protocol endpoint

ST segment elevation resolution (measured by ECG)

Time frame:24 hours

categorical status, improvement

Secondary/protocol endpoint

ST segment elevation resolution (measured by ECG)

Time frame:72 hours

categorical status, improvement

Secondary/protocol endpoint

ST segment elevation resolution (measured by ECG)

Time frame:3 months

categorical status, improvement

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Ratio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI)

Time frame:3 months

ratio, improvement

Secondary/protocol endpoint/low confidence

Left ventricular global and regional LV systolic ejection fraction

Time frame:72 hours

descriptive

Secondary/protocol endpoint/low confidence

Left ventricular volume

Time frame:72 hours

descriptive

Secondary/protocol endpoint/low confidence

Left ventricular volume

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Infarct size/area of risk (measured by cMRI)

Time frame:3 months

descriptive

Secondary/protocol endpoint/low confidence

Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha)

Time frame:24 hours

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.