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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPHI | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide - Upper Arm | Experimental | Participants received 5mg Tirzepatide by subcutaneous injection on upper arm. |
|
| Tirzepatide - Thigh | Experimental | Participants received 5mg Tirzepatide by subcutaneous injection on thigh. |
|
| Tirzepatide - Abdomen | Active Comparator | Participants received 5mg Tirzepatide by subcutaneous injection on abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Tirzepatide administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) was evaluated. | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose |
| PK: Maximum Concentration (Cmax) of Tirzepatide | PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated. | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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There was a washout period of at least 35 days between Tirzepatide injections.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on upper arm in period 1, on thigh in period 2 and on abdomen in period 3. |
| FG001 | Sequence 2 | Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on abdomen in period 1, on upper arm in period 2 and on thigh in period 3. |
| FG002 | Sequence 3 | Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on thigh in period 1, on abdomen in period 2 and on upper arm in period 3. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
| ||||||||||||||||
| Period 3 |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received 5mg Tirzepatide by subcutaneous injection administered through either upper arms or abdomen or thigh as per the dosing sequence. |
| 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 of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) was evaluated. | All randomized participants who received at least one dose of study drug and had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour * nanogram per milliliter (h*ng/mL) | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose |
|
Up to 36 days
All randomized 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 | Tirzepatide - Abdomen | Participants received 5mg Tirzepatide by subcutaneous injection on abdomen. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | 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 | Jun 27, 2019 | Mar 5, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2019 | Mar 5, 2021 | SAP_001.pdf |
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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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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
|
| NOT COMPLETED |
|
|
| 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 |
|
Participants received 5mg Tirzepatide by subcutaneous injection on upper arm. |
| OG002 | Tirzepatide - Thigh | Participants received 5mg Tirzepatide by subcutaneous injection on thigh. |
|
|
|
| Primary | PK: Maximum Concentration (Cmax) of Tirzepatide | PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated. | All randomized participants who received at least one dose of study drug and had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per Millilitre (ng/mL) | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose |
|
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 37 |
| 54 |
| EG001 | Tirzepatide - Upper Arm | Participants received 5mg Tirzepatide by subcutaneous injection on upper arm. | 0 | 54 | 0 | 54 | 31 | 54 |
| EG002 | Tirzepatide - Thigh | Participants received 5mg Tirzepatide by subcutaneous injection on thigh. | 0 | 53 | 0 | 53 | 23 | 53 |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Eructation | 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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| Early satiety | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| 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 |
| Linear mixed effects model |
| Ratio of geometric least squares mean |
| 0.921 |
| 2-Sided |
| 95 |
| 0.874 |
| 0.971 |
| Non-Inferiority |
A priori estimates for the 90% CI geometric least square means ratios of Cmax for the upper arm versus abdomen injection sites were from 0.80 to 1.25. |