DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT03835013

COCOA

CompletedPhase NA

Haemodynamic Effects of GLP-1 and Glucagon in Healthy Male Volunteers

A Comparison of the Haemodynamic and Metabolic Effects of Intravenous Glucagon-like Peptide-1, Glucagon and Glucagon-like Peptide-1:Glucagon Co-agonism in Healthy Male Participants

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

26

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-30•Male

Primary endpoints

•Heart rate, change•Systolic BP, change•Changes in haemodynamic parameters following intravenous infusion of 0.9%

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 IDNCT03835013
Org study IDCOCOA
Secondary ID18/EM/0417REC-HRA
Secondary ID250402IRAS ID

Timeline

Milestones

Study first posted2019-02-08actual
Study start2019-02-11actual
Primary completion2021-11-01actual
Study completion2021-11-01actual
Last update posted2024-04-03actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Written informed consent to participate
•Aged 18 to 40
•Male
•Current non-smoker
•BMI >18.0 and <30kg/m2

Exclusion criteria

•Female
•Sustained Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)
•Clinically significant heart disease
•Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
•Known active malignancy
•Known renal failure (creatinine >140μmol/L)
•Known diabetes mellitus (type 1 or 2)
•Use of vasoactive medications or NSAIDS/aspirin within 24 hours of study visits
•Use of formal anticoagulant therapy such as, but not limited to, heparin, warfarin or rivaroxaban
•Current involvement in the active treatment phase of other research studies, (excluding observations/noninterventional)
•Any other clinical reason which may preclude entry in the opinion of the investigator

Endpoints (14)

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

Cardiometabolic biomarkers
7
Glycemic / diabetes
4
Other (unclassified)
2
Safety / tolerability / PK
1

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-5 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

C-peptide AUC

concentration, descriptive

Secondary/protocol endpoint/low confidence

Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

concentration, descriptive

Secondary/protocol endpoint/low confidence

Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

change from baseline, descriptive

Cardiometabolic biomarkers

7 endpoints
Primary/protocol endpoint

Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

Heart rate, change

change from baseline, improvement

Primary/protocol endpoint

Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Primary/protocol endpoint

Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

change from baseline, improvement

Primary/protocol endpoint

Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

change from baseline, descriptive

Primary/protocol endpoint

Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

change from baseline, improvement

Primary/protocol endpoint

Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

Free fatty acids, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

Plasma concentration (steady state)

concentration, descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.

Time frame:Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks

concentration, descriptive

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.