A Parallel-group, Phase 1, Open-label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Renal Impairment Compared With Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 29
- Locations
- 4
- Primary Endpoint
- Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
Study Overview
Brief Summary
The main purpose of this study is to assess the amount of study drug 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 healthy participants. The study will last up to 5 weeks, excluding screening.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normal Participants:
- •Healthy male and female participants as determined by physical examination
- •Participants with normal renal function assessed by estimated glomerular filtration rate (eGFR) ≥ 90 milliliter per minute (mL/min).
- •Body mass index (BMI) ≥ 19.0 and ≤ 40.0 kilograms per meter squared (kg/m²)
- •Male participants who agree to use contraception and female participants of child bearing potential must agree to use contraceptive methods and women not of child bearing potential can participate.
- •Participants with Renal Impairment:
- •Have acceptable blood pressure (BP) and pulse rate, as determined by the investigator
- •Participants with type 2 diabetes must have a glycated hemoglobin (HbA1c) ≥ 5.0% and ≤ 11.5%
- •Are males or females with severe renal impairment as determined by a stable eGFR <30 mL/min, not requiring hemodialysis OR
- •Are males or females with end-stage renal disease (have received hemodialysis for at least 3 months)
Exclusion Criteria
- •Have known allergies to LY3437943 or related compounds
- •Have a current, functioning organ transplant. Nonfunctional renal allografts may be allowed
- •Have any abnormality in the 12-lead electrocardiogram (ECG)
- •Are women with a positive pregnancy test or women who are lactating
Arms & Interventions
LY3437943 (Control)
LY3437943 administered subcutaneous (SC) to participants with normal renal function
Intervention: LY3437943 (Drug)
LY3437943 (Severe Renal Impairment)
LY3437943 administered SC to participants with severe renal impairment
Intervention: LY3437943 (Drug)
LY3437943 (End-Stage Renal Disease)
LY3437943 administered SC to participants with end-stage renal disease
Intervention: LY3437943 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
Time Frame: Predose up to 31 days postdose
PK: AUC0-∞ of LY3437943
PK: Maximum observed concentration (Cmax) of LY3437943
Time Frame: Predose up to 31 days postdose
PK: Cmax of LY3437943
Secondary Outcomes
No secondary outcomes reported