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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPIP | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP) | Experimental | Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations. |
|
| Sequence 2: Tirzepatide by MUPFP / SDP | Experimental | Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide | PK: Cmax of Tirzepatide | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide | PK: AUC(0-t) of Tirzepatide | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide | PK: AUC(0-∞) of Tirzepatide | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. |
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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 |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States | ||
| ICON Early Phase Services |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Tirzepatide by SDP / MUPFP | Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via a Single-Dose Pen (SDP) in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a Multi-use Prefilled Pen (MUPFP) in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations. |
| FG001 | Sequence 2: Tirzepatide by MUPFP / SDP | Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||||||||
| Period 2 |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1: Tirzepatide by SDP / MUPFP | Participants received a single dose of 5 mg tirzepatide administered SC via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations. |
| BG001 |
| 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): Maximum Concentration (Cmax) of Tirzepatide | PK: 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 | nanograms per milliliter (ng/mL) | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. |
|
Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
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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 (SDP) | Participants received 5 mg tirzepatide SC via an SDP. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | 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 | May 30, 2023 | Jul 9, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2023 | Jul 9, 2024 | 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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|
| Single Dose Pen | Device | Used to administer tirzepatide SC |
|
| Multi-use Prefilled Pen | Device | Used to administer tirzepatide SC |
|
| San Antonio |
| Texas |
| 78209 |
| United States |
| ICON | Salt Lake City | Utah | 84124 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| Sequence 2: Tirzepatide by MUPFP / SDP |
Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations. |
| BG002 | 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 |
|
|
|
| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide | PK: AUC(0-t) 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, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. |
|
|
|
| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide | PK: AUC(0-∞) of Tirzepatide | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. |
|
|
|
| 65 |
| 0 |
| 65 |
| 38 |
| 65 |
| EG001 | Tirzepatide (MUPFP) | Participants received 5 mg tirzepatide SC via a MUPFP. | 0 | 62 | 0 | 62 | 28 | 62 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
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| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |