GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382

A Phase 1, Open-label Study to Compare the Pharmacokinetics and Pharmacodynamics of Warfarin and Esmolol in the Absence and Presence of MEDI0382 in Healthy Subjects

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-30•Healthy volunteers

Primary endpoints

•Maximum international normalized ratio (INRmax)•Heart rate, change

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 IDNCT03347968

Org study IDD5670C00009

Timeline

Milestones

Study first posted2017-11-20actual

Study start2017-11-27actual

Primary completion2018-04-09actual

Study completion2018-04-09actual

Last update posted2018-04-25actual

Assets

Investigational agents

Cotadutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy volunteers aged ≥ 18 to 45 years

•BMI between 18 -30 kg/m2

•Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception

Exclusion criteria

•Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product

•Receipt of investigational product as part of a clinical study or a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.

•Concurrent participation in another study of any kind

•Severe allergy/hypersensitivity to any of the proposed study treatments or excipients.

•History or presence of gastrointestinal (GI), hepatic, or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs.

•Impaired renal function is defined as estimated glomerular filtration rate (eGFR) < 60 mL/minute/1.73 m2 at screening.

•Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of screening.

•History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.

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

Safety / tolerability / PK

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

Change in heart rate from resting after a 9-minute excercise treadmill test (Bruce Protocol, first 3 stages)

Time frame:Days 1 and 26

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Maximum international normalized ratio (INRmax)

Time frame:Days 2-8 and Days 27-33

descriptive

Primary/protocol endpoint

Maximum international normalized ratio (INRmax)

Time frame:Days 2-8 and Days 27-33

descriptive

Secondary/protocol endpoint

PK(AUC) of R-Warfarin and S-Warfarin

Time frame:Days 2 and 27

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK (Cmax) of R-Warfarin and S-Warfarin

Time frame:Days 2 and 27

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of patients with Adverse Events (AEs)

Time frame:33 Days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

Time frame:Day 1, Day 8, Day 13, and Day 18

descriptive

Secondary/protocol endpoint

Anti-drug antibody titer incidence

Time frame:Days 1 and 33

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Clinical laboratory assessments (hematology)

Time frame:Days 1 and 33

descriptive

Secondary/protocol endpoint

Vital signs (systolic and diastolic blood pressure)

Time frame:Days 1-8, Days 12 and 13, Days 25-33

descriptive

Secondary/protocol endpoint

Vital signs (pulse rate and respiratory rate

Time frame:Days 1-8, Days 12 and 13, Days 25-33

descriptive

Secondary/protocol endpoint

Clinical laboratory assessments (serum chemistry)

Time frame:Day -1, Day 8, Day 17, Day 25 and Day 33

descriptive

Secondary/protocol endpoint

Clinical laboratory assessment (urinalysis)

Time frame:Day -1

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.