DelfaGLP-1 Atlas

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CompletedPhase 3Results posted

Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome

MB001-067 A PROSPECTIVE, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, RANDOMIZED TRIAL OF EXTENDED RELEASE EXENATIDE VERSUS PLACEBO (COHORT A) AND A PROSPECTIVE, SINGLE GROUP, OPEN-LABEL, BLINDED OUTCOME TRIAL OF EXTENDED RELEASE EXENATIDE (COHORT B) IN DIABETIC PATIENTS WITH TYPE 4 CARDIORENAL SYNDROME (EXTEND-CRS TRIAL) AMENDMENT 3

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

57

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

•HbA1c 6.6-9.9%•eGFR 50-90

Primary endpoints

•Galectin-3•ST2•NGAL

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 IDNCT02251431
Org study ID014-149
Secondary IDD5551L00004/ISSEXEN0013AstraZeneca

Timeline

Milestones

Study first posted2014-09-29estimated
Results first posted2023-05-17actual
Last update posted2026-02-19actual
Study start2015-11actual (month precision)
Primary completion2019-12actual (month precision)
Study completion2019-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18
•Type 2 diabetes mellitus with hemoglobin A1C 6.6-9.9% with or without the use of insulin
•Estimated glomerular filtration rate (eGFR) between 50 and 90 ml/min/1.73 m2

Exclusion criteria

•Allergy or intolerance to gadolinium
•Implanted cardiac pacemaker, defibrillator, loop recorder, or other implanted metallic device
•Any other metallic implanted device that is a contra-indication to MRI scanning
•eGFR < 50 ml/min/1.73 m2
•eGFR > 90 ml/min/1.73 m2
•Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA™ (exenatide), BYDUREON™ (Exenatide extended-release), VICTOZA™ (liraglutide), or taspoglutide
•Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
•Disorders of iron metabolism
•Collagen vascular diseases
•Myocardial infarction
•Use of DDP4 inhibitors, and PPAR gamma agonists
•Pregnancy or planned pregnancy during the trial period
•Hemoglobin A1C of ≥ 10.0% or <6.6%
•Fasting glucose ≥ 260 mg/dl
•Clinically significant abnormal baseline laboratories
•Morbid obesity or body girth that prohibits the ability to undergo echocardiography or MRI scanning with high-quality image results
•Renal transplantation
•Severe gastrointestinal, liver, or neurodegenerative disease
•Decompensated liver cirrhosis (Child-Pugh score >7)
•New York Heart Association Class III or IV heart failure
•Patients have alanine aminotransaminase (ALT) greater than 5 times the upper limit of the reference range.
•Prior pancreatitis
•Personal or family history of medullary thyroid adenoma or carcinoma (MTC)
•Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
•History of severe hypoglycemia
•Prior bariatric surgery

Endpoints (13)

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

Renal / kidney
9
Cardiometabolic biomarkers
3
Heart failure
1

Heart failure

1 endpoint
Primary/protocol endpoint

BNP

Time frame:38 weeks

NT-proBNP, change

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Exenatide-extended ReleaseBaseline4.87—
End of study (38th week)5.59—
PlaceboBaseline9.88—
End of study (38th week)14.02—

Renal / kidney

9 endpoints
Primary/protocol endpoint

NGAL

Time frame:38 weeks

ratio, improvement

Posted result

GroupValue (mean), ng/mmol Creat95% CI
Exenatide-extended ReleaseBaseline17.35—
End of study (38th week)14.01—
PlaceboBaseline18.44—
End of study (38th week)24.39—
Primary/protocol endpoint

KIM-1

Time frame:38 weeks

ratio, improvement

Posted result

GroupValue (mean), ng/mmol Creat95% CI
Exenatide-extended ReleaseBaseline0.1—
End of study (38th week)0.13—
PlaceboBaseline0.13—
End of study (38th week)0.1—
Primary/protocol endpoint

L-FABP

Time frame:38 weeks

ratio, improvement

Posted result

GroupValue (mean), ng/mmol Creat95% CI
Exenatide-extended ReleaseBaseline2.61—
End of study (38th week)2.05—
PlaceboBaseline3.24—
End of study (38th week)3—
Primary/protocol endpoint

IL-18

Time frame:38 weeks

ratio, improvement

Posted result

GroupValue (mean), pg/mmol Creat95% CI
Exenatide-extended ReleaseBaseline1.68—
End of study (38th week)1.96—
PlaceboBaseline3.48—
End of study (38th week)2.68—
Primary/protocol endpoint

Alpha GST

Time frame:38 weeks

ratio, improvement

Posted result

GroupValue (mean), ng/mmol Creat95% CI
Exenatide-extended ReleaseBaseline0.06—
End of study (38th week)0.05—
PlaceboBaseline0.67—
End of study (38th week)0.27—
Primary/protocol endpoint/low confidence

Pi GST

Time frame:38 weeks

ratio, improvement

Posted result

GroupValue (mean), ng/mmol Creat95% CI
Exenatide-extended ReleaseBaseline2.2—
End of study (38th week)3.03—
PlaceboBaseline3.99—
End of study (38th week)4.27—
Primary/protocol endpoint

NAG

Time frame:38 weeks

ratio, improvement

Posted result

GroupValue (mean), ng/mmol Creat95% CI
Exenatide-extended ReleaseBaseline17.35—
End of study (38th week)14.01—
PlaceboBaseline18.44—
End of study (38th week)24.39—
Primary/protocol endpoint

Cystatin-C

Time frame:38 weeks

ratio, improvement

Posted result

GroupValue (mean), ng/mmol Creat95% CI
Exenatide-extended ReleaseBaseline2.07—
End of study (38th week)1.47—
PlaceboBaseline1.84—
End of study (38th week)1.57—
Primary/protocol endpoint

ACR

Time frame:38 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Posted result

GroupValue (mean), ng/mmol Creat95% CI
Exenatide-extended ReleaseBaseline6678.23—
End of study (38th week)3963.49—
PlaceboBaseline9713.65—
End of study (38th week)9825.2—

Cardiometabolic biomarkers

3 endpoints
Primary/protocol endpoint

Galectin-3

Time frame:38 weeks

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Exenatide-extended ReleaseBaseline9570.91—
End of study (38th week)9539.21—
PlaceboBaseline9266.7—
End of study (38th week)8098.78—
Primary/protocol endpoint/low confidence

ST2

Time frame:38 weeks

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Exenatide-extended ReleaseBaseline635.2—
End of study (38th week)524.68—
PlaceboBaseline443.18—
End of study (38th week)534.53—
Primary/protocol endpoint

Troponin I

Time frame:38 weeks

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Exenatide-extended ReleaseBaseline230.85—
End of study (38th week)238.53—
PlaceboBaseline415.65—
End of study (38th week)504.48—

Publications (7)

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.