DelfaGLP-1 Atlas

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ELIXA

CompletedPhase 3Results posted

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

829

Recruiting sites

—

Enrollment

6,068

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•4-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke, Unstable angina hospitalization)

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 IDNCT01147250
Org study IDEFC11319
Secondary ID2009-012852-26
Secondary IDU1111-1116-5558UTN

Timeline

Milestones

Study first posted2010-06-22estimated
Results first posted2016-10-14estimated
Last update posted2016-12-20estimated
Study start2010-06 (month precision)
Primary completion2015-02actual (month precision)
Study completion2015-02actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable angina) with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an ACS which lead to admission to an acute care facility, within 180 days following the ACS event and prior to screening.
•Participants with a history of type 2 diabetes (for participants newly diagnosed, diagnosis was based on the World Health Organization (WHO) criteria: i.e., either a fasting venous plasma glucose concentration ≥ 7.0 mmol/L [126 mg/dL] or 2-hour post glucose load venous plasma glucose ≥ 11.1 mmol/L [200 mg/dL], confirmed on 2 occasions) prior to the screening visit.

Exclusion criteria

•Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.
•Glycosylated hemoglobin (HbA1c) <5.5 % or >11% measured at screening visit.
•Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the double-blind treatment period.
•Participants who had undergone coronary artery bypass graft (CABG) surgery following the qualifying ACS event.
•Participants who had undergone percutaneous coronary intervention (PCI) within 15 days prior to screening.
•Participants with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit.
•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).
•Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Endpoints (4)

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
3
Renal / kidney
1

Cardiovascular outcomes

3 endpoints
Primary/protocol endpoint

Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina

Time frame:From randomization up to the end of study (median follow-up of 25 months)

4-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Unstable angina hospitalization

Posted result

GroupValue (number), participants95% CI
Placebo399—
Lixisenatide406—
Hazard Ratio (HR)1.01795% CI0.886 – 1.168
Hazard Ratio (HR)1.01795% CI0.886 – 1.168p0.8542Log Rank
Secondary/protocol endpoint

Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure

Time frame:From randomization up to the end of study (median follow-up of 25 months)

5-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Unstable angina hospitalization, Heart-failure hospitalization

Posted result

GroupValue (number), participants95% CI
Placebo469—
Lixisenatide456—
Secondary/protocol endpoint

Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure

Time frame:From randomization up to the end of study (median follow-up of 25 months)

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization

Posted result

GroupValue (number), participants95% CI
Placebo659—
Lixisenatide661—

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108

Time frame:Baseline to Week 108 (LOCF)

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Posted result

GroupValue (geometric_mean), percent change95% CI
Placebo34.21—
Lixisenatide24.17—

Publications (12)

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.