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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-JE-GPGC | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to determine:
This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide | Experimental | Participants received escalating doses of 2.5 milligrams (mg), 5 mg, 10 mg and 15 mg of tirzepatide administered into the subcutaneous (SC) tissue of the abdominal wall. |
|
| Placebo | Placebo Comparator | Participants received placebo administered into the SC tissue of the abdominal wall. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record. | Baseline through Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide | Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma. | Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Hachiōji | Tokyo | 192-0071 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo administered into the SC tissue of the abdominal wall. |
| FG001 | 2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1) | Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall. |
| FG002 | 5 mg/10 mg/15 mg Tirzepatide (Cohort 2) | Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall. |
| FG003 | 5 mg Tirzepatide (Cohort 3) | Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall. |
| 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 | Placebo | Participants received placebo administered into the subcutaneous (SC) tissue of the abdominal wall. |
| BG001 | 2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1) | Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the SC tissue of the abdominal wall. |
| 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Day 85 |
|
Up To 85 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 | Placebo | Participants received placebo administered into the SC tissue of the abdominal wall. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | 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 | Oct 15, 2018 | Jun 21, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2017 | Jun 21, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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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| Placebo | Drug | Administered SC. |
|
| PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide |
Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC[0- τ]), where tau is dosing interval of (0-168 hours). |
| Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration |
| Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose | Change from baseline to 8 weeks in Fasting Plasma Glucose was measured to investigate the PD effect of Tirzepatide after multiple SC doses administered to Japanese patients with T2DM | Baseline, Week 8 |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Shinjuku-Ku | Tokyo | 169-0073 | Japan |
| Adverse Event |
|
| BG002 | 5 mg/10 mg/15 mg Tirzepatide (Cohort 2) | Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall. |
| BG003 | 5 mg Tirzepatide (Cohort 3) | Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall. |
| BG004 | 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 |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
| 2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1) |
Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall. |
| OG002 | 5 mg/10 mg/15 mg Tirzepatide (Cohort 2) | Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall. |
| OG003 | 5 mg Tirzepatide (Cohort 3) | Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide | Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma. | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide | Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC[0- τ]), where tau is dosing interval of (0-168 hours). | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms * hours per mL (ng*hr/mL) | Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose | Change from baseline to 8 weeks in Fasting Plasma Glucose was measured to investigate the PD effect of Tirzepatide after multiple SC doses administered to Japanese patients with T2DM | All randomized participants who received at least one dose of drug and have evaluable PK data. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Week 8 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | 2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1) | Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG002 | 5 mg/10 mg/15 mg Tirzepatide (Cohort 2) | Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall. | 0 | 16 | 0 | 16 | 15 | 16 |
| EG003 | 5 mg Tirzepatide (Cohort 3) | Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall. | 0 | 11 | 0 | 11 | 6 | 11 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| D004700 | Endocrine System Diseases |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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