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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZPB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of LY3502970 will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg LY3502970 (Control: Normal Hepatic Function) | Experimental | Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1. |
|
| 1 mg LY3502970 (Mild Hepatic Impairment) | Experimental | Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
|
| 1 mg LY3502970 (Moderate Hepatic Impairment) | Experimental | Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
|
| 1 mg LY3502970 (Severe Hepatic Impairment) | Experimental | Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3502970 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970 | PK: AUC (0-∞) of LY3502970. | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970 | PK: AUC0-tlast of LY3502970. | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970. | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 |
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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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center |
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| Label | URL |
|---|---|
| A Study of LY3502970 in Participants With Impaired and Normal Liver Function | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 mg LY3502970 (Control: Normal Hepatic Function) | Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1. |
| FG001 | 1 mg LY3502970 (Mild Hepatic Impairment) | Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
| FG002 | 1 mg LY3502970 (Moderate Hepatic Impairment) | Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
| FG003 | 1 mg LY3502970 (Severe Hepatic Impairment) | Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 mg LY3502970 (Control: Normal Hepatic Function) | Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1. |
| BG001 | 1 mg LY3502970 (Mild Hepatic Impairment) |
| 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 From Time Zero to Infinity (AUC [0-∞]) of LY3502970 | PK: AUC (0-∞) of LY3502970. | All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram *hour per milliliter (ng*h/mL) | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 |
|
Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
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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 | 1 mg LY3502970 (Control: Normal Hepatic Function) | Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1. |
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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 | Mar 28, 2024 | Apr 16, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2024 | Apr 16, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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| Orlando |
| Florida |
| 32809 |
| United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
| BG002 | 1 mg LY3502970 (Moderate Hepatic Impairment) | Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
| BG003 | 1 mg LY3502970 (Severe Hepatic Impairment) | Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
| 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 |
|
| OG001 | 1 mg LY3502970 (Mild Hepatic Impairment) | Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
| OG002 | 1 mg LY3502970 (Moderate Hepatic Impairment) | Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
| OG003 | 1 mg LY3502970 (Severe Hepatic Impairment) | Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. |
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970 | PK: AUC0-tlast of LY3502970. | All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 |
|
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970. | All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | 1 mg LY3502970 (Mild Hepatic Impairment) | Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | 1 mg LY3502970 (Moderate Hepatic Impairment) | Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | 1 mg LY3502970 (Severe Hepatic Impairment) | Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
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