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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGG | 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 kidney function compared to healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide - Control | Experimental | Group 1 - Tirzepatide 5 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function. |
|
| Tirzepatide - Mild Renal Impairment | Experimental | Group 2 - Tirzepatide 5mg administered SC to participants with mild renal impairment. |
|
| Tirzepatide - Moderate Renal Impairment | Experimental | Group 3 - Tirzepatide 5mg administered SC to participants with moderate renal impairment. |
|
| Tirzepatide - Severe Renal Impairment | Experimental | Group 4 - Tirzepatide 5mg administered SC to participants with severe renal impairment. |
|
| Tirzepatide - End Stage Renal Disease (ESRD) | Experimental | Group 5 - Tirzepatide 5mg administered SC to participants with ESRD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast]) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC[0-tlast]) of Tirzepatide was evaluated. | Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose |
| PK: Maximum Concentration of Tirzepatide | Cmax is the maximum observed concentration of Tirzepatide. | Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose |
| PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC[0-inf]) | Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Tirzepatide was evaluated. | Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose |
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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 renal function, assessed by estimated glomerular filtration rate (eGFR) ≥90 milliliters per minute (mL/min) at screening
Participants with Renal Impairment or ESRD:
-- Males or females with stable mild to severe renal impairment, assessed by eGFR or with ESRD (having received hemodialysis for at least 3 months)
Participants with Type 2 Diabetes Mellitus (T2DM) and Renal Impairment or ESRD:
Exclusion Criteria:
All Participants:
Participants with Renal Impairment or ESRD:
Participants with T2DM and Renal Impairment or ESRD:
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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 | ||
| Clinical Pharmacology of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33778934 | Derived | Urva S, Quinlan T, Landry J, Martin J, Loghin C. Effects of Renal Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide. Clin Pharmacokinet. 2021 Aug;60(8):1049-1059. doi: 10.1007/s40262-021-01012-2. Epub 2021 Mar 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tirzepatide - Control | Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection. |
| FG001 | Tirzepatide - Mild Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| FG002 | Tirzepatide - Moderate Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| FG003 | Tirzepatide - Severe Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| FG004 | Tirzepatide - End Stage Renal Disease (ESRD) | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tirzepatide - Control | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| BG001 | Tirzepatide - Mild Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| 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 Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast]) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC[0-tlast]) of Tirzepatide was evaluated. | 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 Millilitre (ng*h/mL) | Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose |
|
Up to 28days
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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 | Tirzepatide - Control | Participants received single dose of 5 5mg Tirzepatide by subcutaneous injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | 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 | May 3, 2019 | May 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2018 | May 15, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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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|
| Miami |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| BG002 | Tirzepatide - Moderate Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| BG003 | Tirzepatide - Severe Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| BG004 | Tirzepatide - End Stage Renal Disease (ESRD) | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| BG005 | 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 received single dose of 5mg Tirzepatide by subcutaneous injection. |
| OG002 | Tirzepatide - Moderate Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| OG003 | Tirzepatide - Severe Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
| OG004 | Tirzepatide - End Stage Renal Disease (ESRD) | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. |
|
|
| Primary | PK: Maximum Concentration of Tirzepatide | Cmax is the maximum observed concentration 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 per Millilitre (ng/mL) | Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC[0-inf]) | Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Tirzepatide was evaluated. | 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 Millilitre (ng*h/mL) | Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Tirzepatide - Mild Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG002 | Tirzepatide - Moderate Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG003 | Tirzepatide - Severe Renal Impairment | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG004 | Tirzepatide - End Stage Renal Disease (ESRD) | Participants received single dose of 5mg Tirzepatide by subcutaneous injection. | 0 | 8 | 0 | 8 | 3 | 8 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |