GLP-1 Peptide Atlas, by Delfa

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CompletedPhase 1Results posted

LY2189265 and Atorvastatin Interaction Study

Effect of LY2189265 on the Pharmacokinetics of Atorvastatin 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 18.5-30

Primary endpoint

•Pharmacokinetics of Atorvastatin

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 IDNCT01250834

Org study ID11551

Secondary ID2010-021657-39

Secondary IDH9X-MC-GBCPEli Lilly and Company

Timeline

Milestones

Study first posted2010-12-01estimated

Last update posted2014-10-08estimated

Results first posted2014-10-08estimated

Study start2010-12 (month precision)

Primary completion2011-03actual (month precision)

Study completion2011-03actual (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 subjects with female partners of child-bearing potential: Agree and whose partners agree to use two reliable methods of contraception from the time of the first dose until 3 months after the last dose of study drug, as determined by the investigator.

•Female subjects not of child-bearing potential (that is, are postmenopausal or permanently sterilized [for example, tubal occlusion, hysterectomy, bilateral salpingectomy]) will not be required to use contraception. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) with follicle stimulating hormone (FSH) greater than or equal to 40 milliInternational Units per milliliter (mIU/mL).

•Female subjects who have undergone sterilization by tubal ligation: Agree to use a male or female condom used in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of study drug. Such subjects must also test negative for pregnancy at the time of enrollment.

•Have a body mass index (BMI) between 18.5 and 30.0 kilograms per square meter (kg/m^2), inclusive.

•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 frequent blood sampling.

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

Exclusion criteria

•Are currently enrolled in, or discontinued within the last 90 days from a clinical trial involving an investigational drug or device or off-label use of a drug or device 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 or intolerance to atorvastatin.

•Have known allergies to glucagon-like peptide-1 (GLP-1)-related compounds including LY2189265.

•Are persons who have previously completed or withdrawn from this study, or have taken part in any other study investigating LY2189265 or GLP-1-related compounds or incretin mimetics within the last 3 months.

•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 pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, for example esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts absorption and distribution of study drugs (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs.

•Have a history or presence of thyroid disease.

•Show history or evidence of significant active neuropsychiatric disease.

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

•Show evidence of human immunodeficiency virus (HIV) 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.

•Intend to use over-the-counter medication within 7 days prior to dosing or prescription medication (with the exception of vitamin/mineral supplements and/or hormone replacement therapy) within 14 days prior to dosing.

•Use drugs that are known substrates, inducers, or inhibitors of cytochrome P450 (CYP) enzyme pathways or phosphorylated glycoprotein (P-gp) within 14 days prior to the first dose.

•Have donated blood of more than 500 mL within the month prior to screening.

•Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), and are subjects unwilling to stop alcohol consumption from 48 hours before Admission (Day -1) until discharge from the unit for each treatment period, and to limit alcohol intake to a maximum of 2 units/day on all other days from screening through 48 hours prior to the post-study visit (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 subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study.

•Are women of child bearing potential

Endpoints (12)

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.

Safety / tolerability / PK

12 endpoints

Primary/registry result

Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)

Time frame:Pre-dose to 56 hours post-dose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	95% CI
40 mg Atorvastatin Alone	19.5	—
1.5 mg LY2189265 + 40 mg Atorvastatin	5.78	—

Primary/registry result

Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)

Time frame:Pre-dose to 56 hours post-dose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (ngh/mL)	95% CI
40 mg Atorvastatin Alone	82.8	—
1.5 mg LY2189265 + 40 mg Atorvastatin	65.9	—

Primary/protocol endpoint

Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)

Time frame:Pre-dose to 56 hours post-dose

Cmax

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)

Time frame:Pre-dose to 56 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/registry result

Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)

Time frame:Pre-dose to 56 hours post-dose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	95% CI
40 mg Atorvastatin Alone	0.473	—
1.5 mg LY2189265 + 40 mg Atorvastatin	0.360	—

Secondary/registry result

Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)

Time frame:Pre-dose to 56 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/registry result

Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)

Time frame:Pre-dose to 56 hours post-dose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	95% CI
40 mg Atorvastatin Alone	14.4	—
1.5 mg LY2189265 + 40 mg Atorvastatin	5.66	—

Secondary/registry result

Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)

Time frame:Pre-dose to 56 hours post-dose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (ngh/mL)	95% CI
40 mg Atorvastatin Alone	102	—
1.5 mg LY2189265 + 40 mg Atorvastatin	95.9	—

Secondary/protocol endpoint

Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)

Time frame:Pre-dose to 56 hours post-dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)

Time frame:Pre-dose to 56 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)

Time frame:Pre-dose to 56 hours post-dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)

Time frame:Pre-dose to 56 hours post-dose

AUC₀–∞

concentration, 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.