Healthy, Renal Insufficiency
Conditions
Brief summary
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.
Interventions
DRUGLY3502970
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive. * Men and women who agree to use highly effective or effective methods of contraception may participate in this trial. Participants with Normal Renal Function: * Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min) Participants with Renal Impairment: * Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis. * ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing.
Exclusion criteria
* Have a current, functioning organ transplant. Non-functional renal allografts may be allowed. * Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications. * Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy. * Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study. * Have a history or presence of chronic or acute pancreatitis Participants with Renal Impairment: * Have hemoglobin \<8.5 g/dL. * Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970 | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose | PK: (AUC0-∞) of LY3502970 is reported. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970 | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose | PK: AUC0-tlast of LY3502970 is reported. |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose | PK: Cmax of LY3502970 is reported. |
Countries
United States
Contacts
STUDY_DIRECTORCall 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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 17.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 10 | 2 / 6 | 6 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 6 | 0 / 8 |
Outcome results
None listed