DelfaGLP-1 Atlas

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GLIP1

CompletedPhase NA

GLP-1 Analogs for Neuroprotection After Cardiac Arrest

GLP-1 Analogs for Neuroprotection After Out-of-hospital Cardiac Arrest, a Randomized Clinical Trail

Lead sponsor

Jesper Kjaergaard

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

120

actual

Study population

Brain Injuries, Cardiovascular disease

Key I/E criterion

—

Primary endpoints

•Feasibility•Efficacy

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 IDNCT02442791
Org study ID2013-TTMPharma-001

Timeline

Milestones

Study first posted2015-05-13estimated
Last update posted2017-09-28actual
Study start2014-06 (month precision)
Primary completion2016-06actual (month precision)
Study completion2016-06actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Brain InjuriesCardiovascular disease

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Out of hospital cardiac arrest (OHCA) of presumed cardiac cause
•Sustained return of spontaneous circulation (ROSC)
•Unconsciousness (GCS <8 (Glasgow coma scale)) (patients not able to obey verbal commands)
•Sustained ROSC (Sustained ROSC: Sustained ROSC is when chest compressions have been not required for 20 consecutive minutes and signs of circulation persist)

Exclusion criteria

•Conscious patients (obeying verbal commands)
•Females of childbearing potential (unless a negative pregnancy test can rule out pregnancy within the inclusion window)
•In-hospital cardiac arrest (IHCA)
•OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
•Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, clopidogrel) does not exclude the patient).
•Suspected or confirmed acute intracranial bleeding
•Suspected or confirmed acute stroke
•Unwitnessed asystole
•Known limitations in therapy and Do Not Resuscitate-order
•Known disease making 180 days survival unlikely
•Known pre-arrest cerebral performance category 3 or 4
•>4 hours (240 minutes) from ROSC to screening
•Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump/axial flow device*
•Temperature on admission <30°C.
•Known allergy to GLP-1 analogs, including Exenatide
•Known pancreatitis
•Diabetic ketoacidosis,
•Uncorrected blood glucose at admission < 2.5 mmol/l.
–If the systolic blood pressure (SBP) is recovering during the inclusion window (220 minutes) the patient can be included.

Endpoints (10)

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

Other (unclassified)
5
Other clinical outcomes
3
Cardiovascular outcomes
1
Safety / tolerability / PK
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

All cause mortality

Time frame:180 days

All-cause death

time to event, event

SNOMED 419620001

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety: Cumulated incidence of serious adverse events related to study drug: death, need for mechanical hemodynamic support, hypoglycaemia < 3.0 mmol/l, pancreatitis (S-amylase > 3 UNL), need for renal replacement therapy in the first 3 days.

Time frame:180 days

Serious AEs (any)

composite event, event

componentsDeath (safety endpoint), Documented hypoglycemia, Pancreatitis, Kidney-replacement therapy

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint/low confidence

Neurological prognostication

Time frame:Day 5

descriptive

Secondary/protocol endpoint

Cerebral status

Time frame:30 days, 90 days and 180 days

descriptive

Other/protocol endpoint/low confidence

EEG findings

Time frame:Day 3 to 5

categorical status, descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint

Feasibility: Over 90% initiation of study drug infusion

Time frame:4 hours from return of spontaneous circulation

threshold achievement, descriptive

Primary/protocol endpoint/low confidence

Efficacy assessed by Area under the Neuron-specific Enolase curve

Time frame:72 hours from admission

descriptive

Secondary/protocol endpoint/low confidence

Area under Neuron-specific Enolase curves (NSE)

Time frame:48 hours

descriptive

Secondary/protocol endpoint/low confidence

Area under S100b curve

Time frame:48 hours

descriptive

Other/protocol endpoint/low confidence

Left Ventricular Ejection Fraction (LVEF)

Time frame:Day 5 or later

descriptive

Publications (4)

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.