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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGO | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3502970 + [14C]-LY3502970 | Experimental | Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 ([14C]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3502970 | Drug | Administered orally |
| |
| [14C]-LY3502970 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Absolute Bioavailability of LY3502970 | Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed [14C]-LY3502970 compared to oral dosed LY3502970, using formula: [AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome. | Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose. |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma | PK: AUC [0-∞] of Total Radioactivity in Plasma. | 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose |
| PK: AUC [0-∞] of [14C]-LY3502970 in Plasma |
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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 Clinical Research Inc | Madison | Wisconsin | 53704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY3502970 + [14C]-LY3502970 | Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 ([14C]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY3502970 + [14C]-LY3502970 | Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of [14C]-LY3502970 containing approximately 800 nCi radioactivity. |
| 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): Absolute Bioavailability of LY3502970 | Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed [14C]-LY3502970 compared to oral dosed LY3502970, using formula: [AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose. |
|
Baseline through end of the follow-up (Up to Day 19)
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 | LY3502970 + [14C]-LY3502970 | Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of [14C]-LY3502970 containing approximately 800 nCi radioactivity. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel puncture site pain | General 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 5, 2023 | Apr 17, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2024 | Apr 17, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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| Drug |
Administered IV |
|
PK: AUC [0-∞] of [14C]-LY3502970 in Plasma. |
| 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose |
| PK: AUC [0-∞] of LY3502970 in Plasma | PK: AUC [0-∞] of LY3502970 in Plasma. | Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose |
| PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma | PK: Cmax of Total Radioactivity in Plasma. | 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose |
| PK: Cmax of [14C]-LY3502970 in Plasma | PK: Cmax of [14C]-LY3502970 in Plasma. | 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose |
| PK: Cmax of LY3502970 in Plasma | PK: Cmax of LY3502970 in Plasma. | Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose |
| 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 |
|
Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of [14C]-LY3502970 containing approximately 800 nCi radioactivity.
|
|
| Secondary | PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma | PK: AUC [0-∞] of Total Radioactivity in Plasma. | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent*hour per milliliter | 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose |
|
|
|
| Secondary | PK: AUC [0-∞] of [14C]-LY3502970 in Plasma | PK: AUC [0-∞] of [14C]-LY3502970 in Plasma. | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent*hour per milliliter | 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose |
|
|
|
| Secondary | PK: AUC [0-∞] of LY3502970 in Plasma | PK: AUC [0-∞] of LY3502970 in Plasma. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma | PK: Cmax of Total Radioactivity in Plasma. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent per milliliter | 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose |
|
|
|
| Secondary | PK: Cmax of [14C]-LY3502970 in Plasma | PK: Cmax of [14C]-LY3502970 in Plasma. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent per milliliter | 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose |
|
|
|
| Secondary | PK: Cmax of LY3502970 in Plasma | PK: Cmax of LY3502970 in Plasma. | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
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