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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-EW-GBDO | Other Identifier | Eli Lilly and Company |
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The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal hepatic function | Experimental | LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function |
|
| Mild hepatic impairment | Experimental | LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A) |
|
| Moderate hepatic impairment | Experimental | LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B) |
|
| Severe hepatic impairment | Experimental | LY2189265: A single, SC-1.5 mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2189265 | Drug | Subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Observed Concentration (Cmax) | This measure was calculated using non-compartmental analysis techniques. | Predose to 336 hours postdose |
| Pharmacokinetics: Time of Maximum Concentration (Tmax) | This measure was calculated using non-compartmental analysis techniques. | Predose to 336 hours postdose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast]) | This measure was calculated using non-compartmental analysis techniques. | Predose to 336 hours postdose |
| Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity]) | This measure was calculated using non-compartmental analysis techniques. | Predose to 336 hours postdose |
| Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2) | The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques. | Predose to 336 hours postdose |
| Pharmacokinetics: Apparent Total Plasma Clearance (CL/F) | The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques. | Predose to 336 hours postdose |
| Pharmacokinetics: Apparent Volume of Distribution (Vz/F) |
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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:
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:
Hepatic Impaired Participants:
Participants with T2DM (All Study Groups)
Exclusion Criteria:
All participants (including participants with T2DM)
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:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Munich | 81241 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Hepatic Function | LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function |
| FG001 | Mild Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with mild hepatic impairment (Child-Pugh A) |
| FG002 | Moderate Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with moderate hepatic impairment (Child-Pugh B) |
| FG003 | Severe Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with severe hepatic impairment (Child-Pugh C) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who received at least one dose of study drug (LY2189265).
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Hepatic Function | LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function |
| BG001 | Mild Hepatic Impairment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics: Maximum Observed Concentration (Cmax) | This measure was calculated using non-compartmental analysis techniques. | Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data. | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Predose to 336 hours postdose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Hepatic Function | LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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|
The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques. |
| Predose to 336 hours postdose |
| Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Budapest | 1032 | Hungary |
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
| BG002 | Moderate Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B) |
| BG003 | Severe Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Moderate Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B) |
| OG003 | Severe Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C) |
|
|
| Primary | Pharmacokinetics: Time of Maximum Concentration (Tmax) | This measure was calculated using non-compartmental analysis techniques. | Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data. | Median | Full Range | hours | Predose to 336 hours postdose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast]) | This measure was calculated using non-compartmental analysis techniques. | Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data. | Geometric Mean | Geometric Coefficient of Variation | nanograms times hour/milliliter(ng*hr/mL | Predose to 336 hours postdose |
|
|
|
| Primary | Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity]) | This measure was calculated using non-compartmental analysis techniques. | Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data. | Geometric Mean | Geometric Coefficient of Variation | nanograms times hr/milliliter (ng*hr/mL) | Predose to 336 hours postdose |
|
|
|
| Primary | Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2) | The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques. | Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data. | Geometric Mean | Full Range | hours | Predose to 336 hours postdose |
|
|
|
| Primary | Pharmacokinetics: Apparent Total Plasma Clearance (CL/F) | The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques. | Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data. | Geometric Mean | Geometric Coefficient of Variation | liters/hour (L/h) | Predose to 336 hours postdose |
|
|
|
| Primary | Pharmacokinetics: Apparent Volume of Distribution (Vz/F) | The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques. | Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data. | Geometric Mean | Geometric Coefficient of Variation | liters (L) | Predose to 336 hours postdose |
|
|
|
| 0 |
| 11 |
| 10 |
| 11 |
| EG001 | Mild Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A) | 0 | 6 | 5 | 6 |
| EG002 | Moderate Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B) | 1 | 6 | 5 | 6 |
| EG003 | Severe Hepatic Impairment | LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C) | 1 | 3 | 1 | 3 |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment | Event resulted in death |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cerebral hygroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |