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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGE | Other Identifier | Eli Lilly and Company |
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This study has four parts. Each participant will enroll in one part.
Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it.
Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein.
Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution.
Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide following single IV bolus dose of lyophilized formulation.
This study will last approximately 70 days for each part (Part A, Part B or Part D) and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg Tirzepatide SC (Solution)-Part A | Experimental | Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation. |
|
| 5 mg Tirzepatide SC (Lyophilized)-Part A | Experimental | Participants received 5 mg of tirzepatide SC lyophilized formulation. |
|
| 0.5 mg LY3298176 IV-Part B | Experimental | Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide formulation. |
|
| 5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C | Experimental | Participants received tirzepatide subcutaneous solution at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4). |
|
| Placebo SC-Part C | Placebo Comparator | Participants received SC injection of placebo. |
|
| 0.5 mg LY3298176 Bolus IV-Part D |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide | Pharmacokinetics (PK) Part A: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide. | Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose |
| PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide | PK Part A: Maximum observed plasma drug concentration (Cmax) of tirzepatide. | Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose |
| PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide | PK Part B: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide. | Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-Ï„)] of Tirzepatide | PK Part C: Area under the concentration versus time curve during one dosing interval (168 hours) [AUC (0-Ï„)] of tirzepatide. | Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 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 |
|---|---|---|---|---|---|---|
| Covance | Dallas | Texas | 75247 | United States |
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4-part study, Part A (2-period, 2-treatment, crossover study with at least 35 days of washout period), Part B (fixed, single-arm treatment study), Part C (placebo-controlled, 4-week dose escalation study) and Part D (a fixed, single-arm treatment study).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1-Part A | Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation in Period 1 and 5 mg of tirzepatide SC lyophilized formulation in Period 2. |
| FG001 | Sequence 2-Part A | Participants received 5 mg of tirzepatide SC lyophilized formulation in Period 1 and 5 mg of tirzepatide SC solution formulation in Period 2. |
| FG002 | 0.5 mg Tirzepatide IV-Part B | Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide solution formulation. |
| FG003 | Placebo SC-Part C | Participants received SC injection of placebo. |
| FG004 | 5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C | Participants received tirzepatide subcutaneous solution formulation at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4). |
| FG005 | 0.5 mg Tirzepatide Bolus IV-Part D | Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1-Part A | Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation in Period 1 and 5 mg of tirzepatide SC lyophilized formulation in Period 2. |
| BG001 | Sequence 2-Part A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide | Pharmacokinetics (PK) Part A: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide. | All randomized participants from Part A group, who received at least one dose of study drug and had evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter(ng*hr/mL) | Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose |
|
Up To 92 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 | 5 mg Tirzepatide SC (Lyophilized)-Part A | Participants received 5 mg of tirzepatide SC lyophilized formulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 20.1 | 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: GPGE 05 Protocol Addenda (1) | Aug 31, 2018 | Aug 12, 2019 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: GPGE 05 Protocol (a) | Jan 23, 2018 | Aug 12, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2017 | Aug 12, 2019 | SAP_002.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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Part A, B and D are not blinded. Part C is blinded to Participant and Investigator
| Experimental |
Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation. |
|
|
| Tirzepatide | Drug | Administered IV |
|
|
| Placebo | Drug | Administered SC |
|
| Tirzepatide | Drug | Administered IV |
|
|
| PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide | PK Part C: Maximum observed plasma drug concentration (Cmax) of tirzepatide. | Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose |
| PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide | PK Part D: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide. | Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdose |
| Adverse Event |
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants received 5 mg of tirzepatide SC lyophilized formulation in Period 1 and 5 mg of tirzepatide SC solution formulation in Period 2.
| BG002 | 0.5 mg Tirzepatide IV-Part B | Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide solution formulation. |
| BG003 | Placebo SC-Part C | Participants received SC injection of placebo. |
| BG004 | 5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C | Participants received tirzepatide subcutaneous solution formulation at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4). |
| BG005 | 0.5 mg Tirzepatide Bolus IV-Part D | Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation. |
| BG006 | Total | Total of all reporting groups |
| Participants |
| No |
|
| 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 | Number | participants |
|
Participants received 5 mg of tirzepatide SC solution formulation. |
|
|
| Primary | PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide | PK Part A: Maximum observed plasma drug concentration (Cmax) of tirzepatide. | All randomized participants from Part A group, 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) | Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose |
|
|
|
| Primary | PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide | PK Part B: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide. | All randomized participants from Part B group, who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose |
|
|
|
| Secondary | PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-Ï„)] of Tirzepatide | PK Part C: Area under the concentration versus time curve during one dosing interval (168 hours) [AUC (0-Ï„)] of tirzepatide. | All randomized participants from Part C group, who received at least one dose of study drug and had evaluable PK data. As per planned analysis, for 10 mg Tirzepatide SC-Part C arm, no PK samples were collected at 168 hour post dose (after the fourth dose. i.e. following dose at Week 4). Hence, no data was collected to calculate AUC (0-Ï„) for 10 mg Tirzepatide SC-Part C arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose |
|
|
|
| Secondary | PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide | PK Part C: Maximum observed plasma drug concentration (Cmax) of tirzepatide. | All randomized participants participants from Part C group, who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose |
|
|
|
| Secondary | PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide | PK Part D: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide. | All randomized participants from Part D group, who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdose |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 9 |
| 20 |
| EG001 | 5 mg Tirzepatide SC (Solution)-Part A | Participants received 5 mg of tirzepatide SC solution formulation. | 0 | 20 | 0 | 20 | 5 | 20 |
| EG002 | 0.5 mg Tirzepatide IV-Part B | Participants received IV infusion of a single 0.5 mg dose of tirzepatide solution formulation. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | Placebo SC-Part C | Participants received SC injection of placebo. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG004 | 5 mg Tirzepatide SC, First-Part C | Participants received 5 mg of tirzepatide subcutaneous solution formulation on day 1 (week 1). | 0 | 12 | 0 | 12 | 4 | 12 |
| EG005 | 5 mg Tirzepatide SC, Second Dose-Part C | Participants received 5 mg of tirzepatide subcutaneous solution formulation on day 8 (Week 2). | 0 | 12 | 0 | 12 | 2 | 12 |
| EG006 | 7.5 mg LY3298176 SC-Part C | Participants received 7.5 mg of tirzepatide subcutaneous solution formulation on day 15 (week 3). | 0 | 12 | 0 | 12 | 6 | 12 |
| EG007 | 10 mg Tirzepatide SC-Part C | Participants received 10 mg of tirzepatide subcutaneous solution formulation on day 22 (week 4). | 0 | 11 | 0 | 11 | 4 | 11 |
| EG008 | 0.5 mg Tirzepatide Bolus IV-Part D | Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation. | 0 | 8 | 0 | 8 | 3 | 8 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
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| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |