Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZPC | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to assess the amount of study drug (LY3502970) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3502970 will also be evaluated in these participants. The study will last up to 6 weeks including screening period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3502970 (Normal Renal Function) | Experimental | A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function [defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)] on day 1. |
|
| LY3502970 (Severe Renal Impairment) | Experimental | A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function [defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D] on day 1. |
|
| LY3502970 (End-Stage Renal Disease) | Experimental | A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease [defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D] 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 (AUC0-∞) of LY3502970 | PK: (AUC0-∞) of LY3502970 is reported. | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970 | PK: AUC0-tlast of LY3502970 is reported. | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 is reported. | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose |
Not provided
Not provided
Inclusion Criteria:
Participants with Normal Renal Function:
Participants with Renal Impairment:
Exclusion Criteria:
Participants with Renal Impairment:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | ||
| Advanced Pharma CR, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LY3502970 (Normal Renal Function) | A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function [defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)] on day 1. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2023 | Apr 16, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Miami |
| Florida |
| 33147 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Alliance For multispecialty Research, LLC | Knoxville | Tennessee | 37920 | United States |
| LY3502970 (Severe Renal Impairment) |
A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function [defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D] on day 1. |
| FG002 | LY3502970 (End-Stage Renal Disease) | A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease [defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D] on day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LY3502970 (Normal Renal Function) | A single oral dose of 1 mg LY3502970 was administered to participants with normal renal function [defined as an eGFR: ≥ 90 mL/min, and without a diagnosis of T2D] on day 1. |
| BG001 | LY3502970 (Severe Renal Impairment) | A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function [defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D] on day 1. |
| BG002 | LY3502970 (End-Stage Renal Disease) | A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease [defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D] on day 1. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| 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 (AUC0-∞) of LY3502970 | PK: (AUC0-∞) of LY3502970 is reported. | All enrolled participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose |
|
|
| |||||||||||||||||||||||||||||||
| 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 is reported. | All enrolled participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose |
| |||||||||||||||||||||||||||||||||
| Primary | PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 is reported. | All enrolled participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millilitre (ng/mL) | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose |
|
Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY3502970 (Normal Renal Function) | A single oral dose of 1 mg LY3502970 was administered to participants with normal renal function [defined as an eGFR: ≥ 90 mL/min, and without a diagnosis of T2D] on day 1. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | LY3502970 (Severe Renal Impairment) | A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function [defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D] on day 1. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | LY3502970 (End-Stage Renal Disease) | A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease [defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D] on day 1. | 0 | 8 | 0 | 8 | 6 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemodialysis | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2023 | Apr 16, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729680 | orforglipron |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|