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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDA | Other Identifier | Eli Lilly and Company |
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The primary purpose of this study is to help answer the following research questions:
The study is conducted in 4 groups, based on the Child-Pugh classification of hepatic impairment as follows:
Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment (Child-Pugh class C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2605541-Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single subcutaneous (SC) dose of 0.075 milligrams per kilogram (mg/kg) LY2605541 |
|
| LY2605541-Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 |
|
| LY2605541-Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 |
|
| LY2605541-Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2605541 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541 | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541 | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
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Inclusion Criteria:
All Participants (including those with type 2 diabetes mellitus [T2DM] who are controlled by diet)
Participants with Normal Hepatic Function
Participants with Hepatic Impairment
Exclusion Criteria:
All Participants (including those with T2DM)
Participants with Normal Hepatic Function
Participants with Hepatic Impairment
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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 | LY2605541-Normal Hepatic Function | Participants with normal hepatic function received a single subcutaneous (SC) dose of 0.075 milligrams per kilogram (mg/kg) LY2605541 |
| FG001 | LY2605541-Mild Hepatic Impairment | Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 |
| FG002 | LY2605541-Moderate Hepatic Impairment | Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 |
| FG003 | LY2605541-Severe Hepatic Impairment | Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2605541-Normal Hepatic Function | Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541 |
| BG001 | LY2605541-Mild Hepatic Impairment | Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 |
| 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: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541 | All participants who received 1 dose of LY2605541 and had evaluable AUC(0-∞) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole*hours/liter (pmol*h/L) | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 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 | LY2605541-Normal Hepatic Function | Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| C587357 | LY2605541 |
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| 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. | Balatonfüred | 8230 | Hungary |
| BG002 | LY2605541-Moderate Hepatic Impairment | Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 |
| BG003 | LY2605541-Severe Hepatic Impairment | Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Participants with Diabetes | Count of Participants | Participants | No |
|
| OG002 | LY2605541-Moderate Hepatic Impairment | Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 |
| OG003 | LY2605541-Severe Hepatic Impairment | Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 |
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541 | All participants who received 1 dose of LY2605541 and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L | Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | LY2605541-Mild Hepatic Impairment | Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 | 0 | 8 | 0 | 8 | 1 | 8 |
| EG002 | LY2605541-Moderate Hepatic Impairment | Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | LY2605541-Severe Hepatic Impairment | Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541 | 0 | 7 | 0 | 7 | 1 | 7 |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |