DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02673931

GLORIOUS

Active not recruitingPhase NA

GLP-1 and Hyperoxia for Organ Protection in Heart Surgery

Efficacy of a Glucagon-like-peptide-1 Agonist and Restrictive vs. Liberal Oxygen Supply in Patients Undergoing Coronary Artery Bypass Grafting or Aortic Valve Replacement - a 2-by-2 Factorial Designed, Randomized Clinical Study

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

1,400

actual

Study population

Cardiovascular disease

Key I/E criterion

—

Primary endpoint

•Expanded / custom MACE composite (All-cause death, Kidney-replacement therapy, Stroke (any), Heart-failure 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 IDNCT02673931
Org study IDHJE-PHARMA-001

Timeline

Milestones

Study first posted2016-02-04estimated
Last update posted2024-08-28actual
Study start2016-02actual (month precision)
Primary completion2024-09estimated (month precision)
Study completion2024-09estimated (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

•Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained.
•≥ 18 years of age at the time of signing informed consent.
•Ischemic heart disease requiring coronary artery bypass grafting (multi-vessel coronary artery disease or coronary anatomy not suitable for percutaneous coronary intervention) and/or aortic valve disease scheduled for aortic valve replacement, irrespective of other concomitant valve surgery.

Exclusion criteria

•Active treatment with GLP-1 agonists
•Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism or history of or active acute pancreatitis.
•Acute (i.e. off hours, within hours surgery), Sub-acute surgery (i.e. the following days) are eligible.
•Known allergy towards Exenatide/Byetta or albumin (vehicle).
•On the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent). Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study.
•Recipient of any major organ transplant (e.g. lung, liver, heart)
•Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomization or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of > 2.5 years in the opinion of the investigator)
•Currently enrolled in, or at least 30 days not yet elapsed since ending participation in other investigational drug trial(s) for the treatment of diabetes or malignant obesity investigating the use of GLP-1 agonists or receiving other investigational agent(s). Concomitant participation in other non-pharmacological trials is not an exclusion criterion.
•Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
•Pregnant, based on investigator evaluation (e.g., positive human chorionic gonadotropin test) or currently breast feeding.
•Any condition (e.g., psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
•Previous participation in the 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
2
Safety / tolerability / PK
1
Other (unclassified)
1

Cardiovascular outcomes

2 endpoints
Primary/protocol endpoint

Time in days to the first occurring of the following co-primary end-points throughout the follow-up period

Time frame:Minimum 12 months

Expanded / custom MACE composite

time to event, event

componentsAll-cause death, Kidney-replacement therapy, Stroke (any), Heart-failure hospitalization

Secondary/protocol endpoint

Time in days to the occurrence of individual end-points throughout the follow-up period

Time frame:Minimum 12 months

Expanded / custom MACE composite

time to event, event

componentsAll-cause death, Stroke (any), Kidney-replacement therapy, Heart-failure hospitalization

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of serious adverse events

Time frame:12 months

Serious AEs (any)

composite event, event

componentsSerious AEs (any), Pancreatitis, Documented hypoglycemia, eGFR, change

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Time in days to the first occurring primary end-point within 90 days

Time frame:90 days

time to event, event

Publications (3)

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 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.