DRUG
LY3437943
Administered SC.
Status
Completed
Phase
Phase 1
Enrollment
29
Locations
4
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Administered SC.
Timeline
First posted
Nov 10, 2022
Study start
Nov 16, 2022
Primary completion
Sep 5, 2023
Study completion
Sep 5, 2023
Results posted
Not reported
Registry updated
Oct 2, 2023
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
Not reported in the indexed record.
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Orange County Research Center
Tustin, California, United States
Clinical Pharmacology of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Nucleus Networks
Saint Paul, Minnesota, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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