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Recruiting
NCT05611957
A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function
Conditions: Healthy, Renal Insufficiency
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 20
Sponsor: Eli Lilly and Company
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Normal Participants:Healthy male and female participants as determined by physical examinationParticipants 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 investigatorParticipants 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 ORAre 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 compoundsHave a current, functioning organ transplant.
Nonfunctional renal allografts may be allowedHave any abnormality in the 12-lead electrocardiogram (ECG)Are women with a positive pregnancy test or women who are lactating
Source: ClinicalTrials.gov (NCT05611957). StuddyBuddy aggregates publicly available trial information.