CompletedPhase 1Results posted

A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment

A Single Dose Pharmacokinetic Study of LY2189265 in Subjects With Varying Degrees of Hepatic Impairment

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Hepatic impairment

Eligibility highlights

•BMI 19-40•HbA1c 6.5-9%•Healthy volunteers

Primary endpoints

•Cmax•Time of Cmax (Tmax)•AUC

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01253304

Org study ID13765

Secondary IDH9X-EW-GBDOEli Lilly and Company

Timeline

Milestones

Study first posted2010-12-03estimated

Last update posted2014-10-07estimated

Results first posted2014-10-07estimated

Study start2010-11 (month precision)

Primary completion2011-11actual (month precision)

Study completion2011-11actual (month precision)

Assets

Investigational agents

Dulaglutide

Who this study enrolls

Healthy volunteersHepatic impairment

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

All Participants (including participants with type 2 diabetes mellitus [T2DM]):

•Male participants - Agree to use a reliable method of birth control (for example, barrier methods) during the study and for at least 3 months following dosing of study drug

•Female participants:

-Women must be of non-child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause

-Women with an intact uterus are deemed postmenopausal if they are over 45 years old and have had cessation of menses for at least 1 year or have had 6 to 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) >40 international units per milliliter (IU/mL) and have not taken hormone replacement therapy or oral contraceptives within 1 year of study start and are otherwise healthy

-Women who have had cessation of menses for at least 2 years are permitted to take hormone replacement therapy

•Have a body mass index (BMI) between 19.0 and 40.0 kilograms per meters squared (kg/m^2), inclusive, at screening.

•Have venous access sufficient to allow blood sampling

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

•Have given written informed consent approved by Lilly and the ethical review board governing the site

Control Participants:

•Overtly healthy participants with normal hepatic function

•Participants with T2DM with normal hepatic function

•Have normal sitting blood pressure and pulse rate as determined by the investigator or with changes compatible with their age and disease status in case of patients with T2DM

•Have clinical laboratory test results within normal reference range for the investigator site or results with minor deviations not considered to be clinically significant by the investigator or with changes compatible with their age and disease status in case of T2DM

Hepatic Impaired Participants:

•Have stable hepatic impairment (such as, post-alcoholic, chronic hepatitis, biliary cirrhosis, or cryptogenic) classified as Child-Pugh Class A, B, or C (mild, moderate, and severe impairment) who are considered by the investigator as acceptable for participation in the study. The hepatic-impaired participant population may include patients with T2DM.

•Have sitting blood pressure and pulse rate compatible with their disease state [including T2DM, if applicable] as determined by the investigator.

Participants with T2DM (All Study Groups)

•Have T2DM controlled with diet and exercise alone or T2DM is stable on a single, oral agent antihyperglycemic medication (metformin, sulfonylureas, repaglinide, nateglinide, acarbose [or other disaccharidase inhibitors], or thiazolidinediones) for at least 3 weeks (3 months for thiazolidinediones) prior to admission

•Have a glycosylated hemoglobin (HbA1C) value at screening (or within 4 weeks prior to screening) of 6.5% to 9.0%

•Have clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable

•Have acceptable blood pressure and pulse rate (sitting), as determined by the investigator

Exclusion criteria

All participants (including participants with T2DM)

•Are currently enrolled in, discontinued within the last 30 days from a clinical trial involving use of an investigational drug or device other than the study drug, 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 LY2189265 or related compounds

•Have previously completed or withdrawn from this study or any other study investigating LY2189265

•Have a current, functioning organ transplant

•Show evidence of significant active, uncontrolled, endocrine or autoimmune abnormalities (such as, thyroid disease or pernicious anemia) as judged by the screening physician

•Have shown febrile illness within 3 days prior to 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

•Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that are not otherwise explained by permitted concomitant medications

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

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

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

•Have an average weekly alcohol intake that exceeds 21 units per week (men) and 14 units per week (women) (1 unit = 12 ounces [oz] or 360 mL of beer, 5 oz or 150 mL of wine, or 1.5 oz or 45 mL of distilled spirits)

•Are unwilling to stop alcohol consumption for the duration of the study (from screening until the follow-up visit)

•Are participants who smoke more than 10 cigarettes per day, are unwilling to refrain from smoking on the day of LY2189265 administration, or are unable to abide by clinical research unit (CRU) restrictions on other inpatient days

•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 [such as, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy] or could be aggravated by glucagon like peptide [GLP] analogs). Participants with mild hypertension and 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.

•Are participants deemed to be unsuitable by the investigator for any reason.

Control participants:

•Have a history or presence of cardiovascular (such as, myocardial infarction, cerebrovascular accident, venous thromboembolism), respiratory, renal, endocrine (with exception of participants with T2DM), hematological, neurological disorders, cancer, hepatic (including Gilbert's disease), or dermatological disorders or diseases 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

•Show evidence of significant active neuropsychiatric disease

•Have creatinine clearance less than 80 milliliters per minute (mL/min) (as calculated by the Cockcroft-Gault equation)

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

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

•Intend to use:

-Over-the-counter medication (including herbal remedies/health supplements) within 7 days prior to dosing

-Prescription medication within 14 days prior to dosing participants with mild, moderate, and severe hepatic impairment

•Show evidence of any significant active disease other than that responsible for or associated with hepatic impairment. Participants with hypertension and hyperlipidemia may be permitted at the investigator's discretion.

•Show, in the opinion of the investigator, evidence of significant neuropsychiatric disease other than Grade 1 hepatic encephalopathy

•Show evidence of spontaneous bacterial peritonitis within 6 months of dosing.

•Show evidence of severe hyponatremia (Sodium [Na] <120 millimoles per liter [mmol/L])

•Show presence of hepatocellular carcinoma

•Have a portal shunt

•Show evidence of severe ascites

•Have hemoglobin <9.0 grams per deciliter (g/dL)

•Have platelet count <40 x 10^9 cells per liter (cells/L)

•Have total serum bilirubin >15 milligrams per deciliter (mg/dL)

•Use medication known to interfere with hepatic metabolism (that is, barbiturates, phenothiazines) or known to alter other major organs or systems

Mild, Hepatic Impaired Participants (Child-Pugh A)

•Show evidence of active renal disease with creatinine clearance <70 mL/min calculated by the Cockcroft-Gault equation.

•Moderate and Severe Hepatic Impaired Subjects (Child-Pugh B and C)

•Show evidence of hepatorenal syndrome as shown by creatinine clearance <50 mL/min calculated by the Cockcroft-Gault equation.

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.

Safety / tolerability / PK

14 endpoints

Primary/registry result

Pharmacokinetics: Maximum Observed Concentration (Cmax)

Time frame:Predose to 336 hours postdose

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · nanograms/milliliter (ng/mL)	95% CI
Normal Hepatic Function	84.5	-
Mild Hepatic Impairment	63.0	-
Moderate Hepatic Impairment	58.1	-
Severe Hepatic Impairment	61.3	-

Primary/registry result

Pharmacokinetics: Time of Maximum Concentration (Tmax)

Time frame:Predose to 336 hours postdose

Tmax

descriptive

Posted result

Group	Median · hours	95% CI
Normal Hepatic Function	48.00	24.02 - 72.02
Mild Hepatic Impairment	48.01	47.95 - 72.02
Moderate Hepatic Impairment	59.96	47.10 - 95.97
Severe Hepatic Impairment	71.93	71.90 - 71.98

Primary/registry result

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])

Time frame:Predose to 336 hours postdose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · nanograms times hour/milliliter(ng*hr/mL	95% CI
Normal Hepatic Function	10200	-
Mild Hepatic Impairment	7670	-
Moderate Hepatic Impairment	7220	-
Severe Hepatic Impairment	7660	-

Primary/registry result

Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])

Time frame:Predose to 336 hours postdose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · nanograms times hr/milliliter (ng*hr/mL)	95% CI
Normal Hepatic Function	16300	-
Mild Hepatic Impairment	12200	-
Moderate Hepatic Impairment	11200	-
Severe Hepatic Impairment	12500	-

Primary/registry result

Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)

Time frame:Predose to 336 hours postdose

Half-life

descriptive

Posted result

Group	Geometric mean · hours	95% CI
Normal Hepatic Function	104	88.6 - 116
Mild Hepatic Impairment	101	86.2 - 116
Moderate Hepatic Impairment	88.2	75.1 - 104
Severe Hepatic Impairment	99.2	76.4 - 121

Primary/registry result

Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)

Time frame:Predose to 336 hours postdose

descriptive

Posted result

Group	Geometric mean · liters/hour (L/h)	95% CI
Normal Hepatic Function	0.0920	-
Mild Hepatic Impairment	0.123	-
Moderate Hepatic Impairment	0.135	-
Severe Hepatic Impairment	0.120	-

Primary/registry result

Pharmacokinetics: Apparent Volume of Distribution (Vz/F)

Time frame:Predose to 336 hours postdose

descriptive

Posted result

Group	Geometric mean · liters (L)	95% CI
Normal Hepatic Function	13.8	-
Mild Hepatic Impairment	17.9	-
Moderate Hepatic Impairment	17.1	-
Severe Hepatic Impairment	17.1	-

Primary/protocol endpoint

Pharmacokinetics: Maximum Observed Concentration (Cmax)

Time frame:Predose to 336 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics: Time of Maximum Concentration (Tmax)

Time frame:Predose to 336 hours postdose

Tmax

descriptive

Primary/protocol endpoint

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])

Time frame:Predose to 336 hours postdose

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])

Time frame:Predose to 336 hours postdose

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)

Time frame:Predose to 336 hours postdose

Half-life

descriptive

Primary/protocol endpoint

Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)

Time frame:Predose to 336 hours postdose

descriptive

Primary/protocol endpoint

Pharmacokinetics: Apparent Volume of Distribution (Vz/F)

Time frame:Predose to 336 hours postdose

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.