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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGS | 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 given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected.
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide Test | Experimental | Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods. |
|
| Tirzepatide Reference | Experimental | Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods. |
|
| 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 Infinity (AUC0toinf) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported. | Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose |
| PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide | PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported | Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose |
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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 |
|---|---|---|---|---|---|---|
| Lilly Nus Centre for Clin Pharmacology | Singapore | 138623 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A | Participants received single dose of 5 milligram (mg) tirzepatide by subcutaneous injection (SC) administered through autoinjector on day 1 of period 1. Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe on day 1 of period 2. |
| FG001 | Sequence B | Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe on day 1 of period 1. Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector on day 1 of period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| ||||||||||||||||||||||||
| Period 2 |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received 5mg of tirzepatide by SC injection administered by autoinjector or prefilled syringe on day 1 of each period 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 (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported. | 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*hour per milliliter (ng*h/mL) | Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose |
|
Up to 72 days
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 | 5 mg Tirzepatide AI | Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site phlebitis | General disorders | MedDRA 22.0 | Systematic Assessment |
| 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 4, 2019 | Jul 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2019 | Jul 15, 2020 | 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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| Prefilled syringe (PFS) | Device | PFS used to administer tirzepatide |
|
| Auto-injector (AI) | Device | AI used to administer tirzepatide |
|
| Adverse Event |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received single dose of 5mg tirzepatide by SC injection administered through prefilled syringe. |
|
|
| Primary | PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide | PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported | 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 Milliliter (ng/mL) | Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 40 |
| 42 |
| EG001 | 5 mg Tirzepatide PFS | Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe. | 0 | 44 | 1 | 44 | 42 | 44 |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Eructation | 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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| Catheter site bruise | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Catheter site phlebitis | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Vessel puncture site phlebitis | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Viral upper respiratory 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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| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal 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 |