DelfaGLP-1 Atlas

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COCONUT

CompletedPhase 4

Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants with Type 2 Diabetes

A Pilot Study on the Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants with Type 2 Diabetes (COCONUT)

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

10

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥25

Primary endpoints

•Part A - Myocardial glucose uptake•Part A - Global longitudinal strain / global circumferential strain / global•Part A - Ejection fraction

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 IDNCT04307797
Org study IDCOCONUT

Timeline

Milestones

Study first posted2020-03-13actual
Study start2022-01-18actual
Primary completion2022-10-07actual
Study completion2022-10-07actual
Last update posted2024-09-19actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Written informed consent to participate
•Aged >18 years
•Clinical diagnosis of T2DM, either diet controlled or treated with metformin (to be withheld on the morning of the imaging visit)
•BMI ≥25kg/m2
•Current non-smoker

Exclusion criteria

•Females of childbearing potential (Part A only) / current pregnancy (all parts)
•Sustained Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)
•Clinically significant heart disease
•Implanted heart pacemaker or implantable cardioverter defibrillator (ICD)
•Known active malignancy other than skin cancer
•Known renal failure (creatinine >150µmol/L)
•Known type one diabetes mellitus / known or clinically suspected diagnosis of a monogenic form of diabetes
•Poorly controlled blood glucose
•Current daily use of anti-diabetic medication including Insulin, GLP-1 based agonists, DPP4i or any other medication known to interact with either of the study drugs (exenatide or glucagon)
•Current involvement in the active treatment phase of other research studies, (excluding observational/non-interventional).
•Contraindication for MRI/PET scan, i.e. any reason which precludes MRI imaging according to local policy (ie internal pacemaker/defibrillator, metal fragments, claustrophobia)
•Participation in research studies in the last 3 years involving radiation (if the effective dose exceeded 10mSv). This does not include any diagnostic or therapeutic exposures which were clinically justified.
•Any other clinical reason which may preclude entry in the opinion of the investigator

Endpoints (21)

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)
13
Glycemic / diabetes
4
Cardiometabolic biomarkers
3
Safety / tolerability / PK
1

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Part A/B - Glucose

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Part A/B - Glucagon

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part A/B - Insulin

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part A/B - C-peptide

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Part A/B - Heart rate

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Part A/B - Blood pressure

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Part A/B - fatty acids

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Free fatty acids, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint/low confidence

Part A/B - exenatide

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

concentration, descriptive

Other (unclassified)

13 endpoints
Primary/protocol endpoint/low confidence

Part A - Myocardial glucose uptake

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Part A - Global longitudinal strain / global circumferential strain / global radial strain

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part A - Ejection fraction

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part A - Stroke volume

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Part A - Cardiac output

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Part B - Changes in phosphocreatine/adenosine (PCr/ATP) radio

Time frame:Comparison between scans over a maximum period of 16 weeks

ratio, descriptive

Primary/protocol endpoint/low confidence

Part B - Changes in absolute concentrations of PCr and ATP defined by AHA 17- segment territory as a measure of cardiac energy status (determined by 31P-MRS)

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part A - End systolic/diastolic ventricular/atrial volumes

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Part A - Radial strain

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Part A - Global systolic/diastolic longitudinal/circumferential/radial strain rate

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part A - Relationship between early and late filling (from mitral flow)

Time frame:Comparison between scans over a maximum period of 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Part A/B - Total GLP-1 and total active GLP-1

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part A/B - gastric inhibitory polypeptide

Time frame:Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

change from baseline, descriptive

Publications (1)

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.