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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPIN | Other Identifier | Eli Lilly and Company |
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The main purpose of this study was to look if the study drug, tirzepatide, gets into the breastmilk and, if yes, how long it takes the body to get rid of it from the breastmilk. The study drug was given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study was approximately 8 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg Tirzepatide | Experimental | Participants received a single dose of 5 mg tirzepatide injection administered subcutaneously (SC). |
|
| 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 of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞]) | PK: AUC (0-∞) of Tirzepatide excreted in Breastmilk | Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 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 |
|---|---|---|---|---|---|---|
| Las Vegas Clinical Research Unit - PPD | Las Vegas | Nevada | 89113-2228 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 mg Tirzepatide | Participants received a single dose of 5 mg tirzepatide injection administered subcutaneously (SC). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg Tirzepatide | Participants received a single dose of 5 mg tirzepatide injection administered SC. |
| 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 in Breastmilk From Zero to Infinity (AUC [0-∞]) | PK: AUC (0-∞) of Tirzepatide excreted in Breastmilk | Participants who received a dose of tirzepatide were eligible for this outcome analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hours per milliliter (ng*h/mL) | Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dose |
|
|
Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
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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 | Participants received a single dose of 5 mg tirzepatide injection administered SC. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | 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 | Sep 15, 2023 | Mar 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2023 | Mar 4, 2025 | 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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| 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 |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 11 |
| 11 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal 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 |