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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPHU | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes.
The study will last about 13 weeks for each participant, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide + Acetaminophen | Experimental | Participants received 5mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered subcutaneously (SC) and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Tirzepatide administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen | Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
| PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen | Maximum Observed Drug Concentration (cmax) of Acetaminophen | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) Data by Diabetic Status | Levels of Hemoglobin A1c (HbA1c) were assessed at predose on Day 29, and at follow-up (Day 64). | Predose on Day 29 and follow-up (Day 64) |
| PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic |
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Inclusion Criteria:
Key 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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Hialeah | Florida | 33014 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Diabetic | Participants received 5 milligrams (mg) tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered subcutaneously (SC) and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37. |
| FG001 | Type 2 Diabetes Mellitus (T2DM) | Participants received 5mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Diabetic | Participants received 5 mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37. |
| BG001 | T2DM |
| 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 Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen | Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen | All randomized participants who received at least one dose of acetaminophen and have evaluable acetaminophen PK data. | Posted | Geometric Mean | 90% Confidence Interval | nanograms*hours per milliliter (ng*h/mL) | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
|
Baseline Up To 45 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 | Non-diabetic | Participants received 5 mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 23.0 | 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 | Jul 23, 2020 | Jun 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2020 | Jun 7, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| D000082 | Acetaminophen |
| 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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| Acetaminophen | Drug | Acetaminophen administered orally. |
|
Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic |
| Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM | Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
| PK: Cmax of Acetaminophen at Steady State Non-diabetic | PK: Cmax of Acetaminophen at Steady State Non-diabetic | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
| PK: Cmax of Acetaminophen at Steady State For T2DM | PK: Cmax of Acetaminophen at Steady State T2DM | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
Participants received 5 mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37. |
| 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 |
|
| OG001 |
| Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2) |
Participants received 5 mg tirzepatide on Day 1 and Day 8 and 160 mg acetaminophen administered orally Day 2. |
| OG002 | Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37) | Participants received 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day 37. |
|
|
|
| Primary | PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen | Maximum Observed Drug Concentration (cmax) of Acetaminophen | All randomized participants who received at least one dose of acetaminophen and have evaluable acetaminophen PK data. | Posted | Geometric Mean | 90% Confidence Interval | nanograms per milliliter (ng/mL) | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
|
|
|
|
| Secondary | Hemoglobin A1c (HbA1c) Data by Diabetic Status | Levels of Hemoglobin A1c (HbA1c) were assessed at predose on Day 29, and at follow-up (Day 64). | All participants who received at least one dose of acetaminophen or tirzepatide, whether or not they completed all protocol requirements | Posted | Mean | Standard Deviation | Percentage of HbA1c | Predose on Day 29 and follow-up (Day 64) |
|
|
|
| Secondary | PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic | Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic | All participants who received at least one dose of acetaminophen and have evaluable acetaminophen PK data. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | nanograms*hours per milliliter (ng*h/mL) | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
|
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM | Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM | All participants who received at least one dose of acetaminophen and have evaluable acetaminophen PK data. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | nanograms*hours per milliliter (ng*h/mL) | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
|
|
|
|
| Secondary | PK: Cmax of Acetaminophen at Steady State Non-diabetic | PK: Cmax of Acetaminophen at Steady State Non-diabetic | All participants who received at least one dose of acetaminophen and have evaluable acetaminophen PK data. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | nanograms per milliliter (ng/mL) | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
|
|
|
|
| Secondary | PK: Cmax of Acetaminophen at Steady State For T2DM | PK: Cmax of Acetaminophen at Steady State T2DM | All participants who received at least one dose of acetaminophen and have evaluable acetaminophen PK data. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | nanograms per milliliter (ng/mL) | Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37 |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 16 |
| 18 |
| EG001 | T2DM | Participants received 5 mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered SC and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37. | 0 | 18 | 0 | 18 | 16 | 18 |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Ratio of geometric least squares mean |
| 0.679 |
| 2-Sided |
| 90 |
| 0.589 |
| 0.783 |
| Superiority |
| Ratio of geometricleast squares mean |
| 1.23 |
| 2-Sided |
| 90 |
| 1.07 |
| 1.42 |
| Superiority |
| Ratio of geometricleast squares mean |
| 1.08 |
| 2-Sided |
| 90 |
| 0.938 |
| 1.25 |
| Superiority |
| Ratio of geometricleast squares mean |
| 0.804 |
| 2-Sided |
| 90 |
| 0.660 |
| 0.979 |
| Superiority |
| Ratio of geometricleast squares mean |
| 0.574 |
| 2-Sided |
| 90 |
| 0.471 |
| 0.698 |
| Superiority |