GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Study of the Effect of Dulaglutide on the Action of Warfarin in Healthy Participants

The Effect of Dulaglutide (LY2189265) on the Pharmacokinetics and Pharmacodynamics of Single Dose Warfarin in Healthy Subjects

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 18.5-32

Primary endpoints

•AUC of R-warfarin and S-warfarin•Cmax of R-warfarin and S-warfarin (Cmax)•Cmax (Tmax) of R-warfarin and S-warfarin

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 IDNCT01432938

Org study ID11549

Secondary IDH9X-MC-GBCSEli Lilly and Company

Timeline

Milestones

Study first posted2011-09-13estimated

Last update posted2014-10-07estimated

Results first posted2014-10-07estimated

Study start2011-09 (month precision)

Primary completion2011-12actual (month precision)

Study completion2011-12actual (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•male participants with female partners of child-bearing potential, or partners who are pregnant or breastfeeding, agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator. The method may be one of the following:

–condom with spermicidal agent

–male participant sterilization

–true abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable)

•female participants not of child-bearing potential and are postmenopausal or have undergone a documented hysterectomy (total or partial). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrolment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) with follicle stimulating hormone (FSH) ≥40 milli-international units per milliliter (mIU/mL)

•have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2), inclusive, at screening

•have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

•have venous access sufficient to allow for blood sampling

•are reliable and willing to make themselves available for the duration of the study and are willing to follow study restrictions

•have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Exclusion criteria

•are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

•have known allergies to glucagon-like-peptide 1 (GLP-1)-related compounds including dulaglutide or to warfarin, related compounds, or any components of either formulation

•are persons who have previously completed or withdrawn from this study or any other study investigating dulaglutide in the 3 months prior to screening or have received glucagon-like peptides or incretin mimetics in the 3 months prior to screening

•history or presence of significant bleeding disorders that is, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intracranial hemorrhage

•have a personal history, family history, or current evidence of a bleeding disorder, coagulopathy, or clinically significant history of bleeding complications after surgical procedures, tooth extractions, nose or gingival bleeding, spontaneous bleeding (including bleeding into joint spaces)

•have a personal or family history of polycystic kidney disease or protein C or S deficiency

•have a history of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within the last 3 months prior to screening

•have a history of or plan to undergo major surgery in the last 3 months prior to screening

•show positive for a fecal occult blood test at screening

•have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study

•have an abnormal blood pressure (after at least 5 minutes sitting) that, in the opinion of the investigator, increases the risks associated with participating in the study

•have a history or presence of cardiovascular, respiratory, hepatic, renal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

•have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, for example relevant esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts gastric emptying (GE) (such as, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs. Participants with mild dyslipidemia, and participants who had cholecystolithiasis (removal of gall stones) and/or cholecystectomy (removal of gall bladder) in the past, with no further sequelae, may be included in the study at the discretion of the screening physician

•Show evidence of significant active neuropsychiatric disease

•have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC

•regularly use known drugs of abuse and/or show positive findings on urinary drug screening

•show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

•show evidence of hepatitis C and/or positive hepatitis C antibody

•show evidence of hepatitis B and/or positive hepatitis B surface antigen

•are women with a positive pregnancy test or women who are lactating

•have used or intend to use over-the-counter medication other than acetaminophen within 7 days prior to the first dose of warfarin or dulaglutide or prescription medication (with the exception of vitamin/mineral supplements and/or hormone replacement therapy [HRT]) within 14 days prior to dosing. Aspirin and other nonsteroidal anti-inflammatory drugs should not be taken from 2 weeks prior to the first dosing occasion

•show intended use of any drug or dietary supplement that may affect warfarin or coagulation within 14 days prior to the first dose of warfarin or dulaglutide or during the conduct of the study

•use or intended use of a drug that inhibits or induces cytochrome P450 (CYP)1A2, CYP2C9, CYP2C19, or CYP3A4 within 14 days prior to the first dose of warfarin or dulaglutide or during the conduct of the study

•have donated blood of more than 500 milliliters (mL) within the month prior to screening

•have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption from 48 hours prior to admission (Day -1 of the first treatment period) until discharge (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)

•are smokers

•have an international normalized ratio/prothrombin time (INR/PT) or activated partial thromboplastin time (aPTT) above the normal reference range at screening

•are females who menstruate

•have consumed grapefruit, cranberries, or grapefruit- or cranberry-containing products within 7 days prior to the first dose of warfarin or dulaglutide

•in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

•have any medical conditions, medical history or are taking any medication which are contraindicated within the warfarin Product Information Leaflet

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

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

8 endpoints

Primary/registry result

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of R-warfarin and S-warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanograms times hours per milliliter	95% CI
Warfarin AloneS-warfarin	19200	—
R-warfarin	33000	—
Dulaglutide + WarfarinS-warfarin	18900	—
R-warfarin	32900	—

Primary/registry result

Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of R-warfarin and S-warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

Cmax

concentration, descriptive

componentsCmax

Posted result

Group	Value (geometric_mean), nanograms per milliliter (ng/mL)	95% CI
Warfarin AloneS-warfarin	530	—
R-warfarin	530	—
Dulaglutide + WarfarinS-warfarin	414	—
R-warfarin	451	—

Primary/registry result

Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-warfarin and S-warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

Tmax

concentration, descriptive

Posted result

Group	Value (median), hours	95% CI
Warfarin AloneS-warfarin	2.00	1.00 – 4.00
R-warfarin	2.00	1.00 – 4.00
Dulaglutide + WarfarinS-warfarin	4.00	1.00 – 24.02
R-warfarin	8.00	2.00 – 24.02

Primary/protocol endpoint

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of R-warfarin and S-warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

AUC₀–∞

concentration, descriptive

componentsAUC₀–∞

Primary/protocol endpoint

Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of R-warfarin and S-warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

Cmax

concentration, descriptive

componentsCmax

Primary/protocol endpoint

Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-warfarin and S-warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

Tmax

descriptive

Secondary/registry result

Pharmacodynamics: Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

concentration, descriptive

Posted result

Group	Value (geometric_mean), ratio	95% CI
Warfarin Alone	157	—
Dulaglutide + Warfarin	161	—

Secondary/registry result

Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax) of Warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

descriptive

Posted result

Group	Value (geometric_mean), ratio	95% CI
Warfarin Alone	1.24	—
Dulaglutide + Warfarin	1.27	—

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Pharmacodynamics: Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax) of Warfarin

Time frame:Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)

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

No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide.
Clinical pharmacokinetics2017 Nov (month)PMID28357715doi:10.1007/s40262-017-0531-7via clinicaltrials gov reference derived + pubmed nct search

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.