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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGQ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants. The study will last about two months and will include five visits to the study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Hepatic Function | Active Comparator | Participants with normal hepatic function received single subcutaneous dose of 5 milligrams (mg) tirzepatide. |
|
| Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
|
| Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
|
| Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide | Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide. | Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose |
| PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide | PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide. | Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose |
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Inclusion Criteria:
All Participants:
Healthy Participants:
- Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function
Participants with Impaired Liver Function:
Exclusion Criteria:
All Participants:
Participants with Impaired Liver Function:
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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 |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35674880 | Derived | Urva S, Quinlan T, Landry J, Ma X, Martin JA, Benson CT. Effects of Hepatic Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide. Clin Pharmacokinet. 2022 Jul;61(7):1057-1067. doi: 10.1007/s40262-022-01140-3. Epub 2022 Jun 8. |
| Label | URL |
|---|---|
| A Study of Tirzepatide in Participants With Impaired Liver Function | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Normal Hepatic Function) | Participants with normal hepatic function received single subcutaneous dose of 5 mg tirzepatide. |
| FG001 | Mild Hepatic Impairment | Participants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
| FG002 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
| FG003 | Severe Hepatic Impairment | Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Normal Hepatic Function) | Participants with normal hepatic function received single subcutaneous dose of 5 mg tirzepatide. |
| BG001 | Mild Hepatic Impairment | Participants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
| 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 (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide | Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose |
|
Baseline to Study Completion (Up to 14 Months)
All participants who received at least one dose of study drug.
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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 | Control (Normal Hepatic Function) | Participants with normal hepatic function received single subcutaneous dose of 5 mg tirzepatide. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2019 | Aug 5, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2019 | Aug 5, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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|
| Orlando |
| Florida |
| 32809 |
| United States |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70112 | United States |
| BG002 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
| BG003 | Severe Hepatic Impairment | Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
| 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 mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.
| OG002 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
| OG003 | Severe Hepatic Impairment | Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. |
|
|
|
| Primary | PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide | PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 4 |
| 13 |
| EG001 | Mild Hepatic Impairment | Participants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | Severe Hepatic Impairment | Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide. | 0 | 7 | 1 | 7 | 2 | 7 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
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| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| Ratio of geometric least squares mean |
| 1.00 |
| 2-Sided |
| 90 |
| 0.802 |
| 1.25 |
| Other |
| Ratio of geometric least squares mean | 0.972 | 2-Sided | 90 | 0.784 | 1.21 | Other |